NATCO records ₹1434.9 Crore consolidated revenue and INR 676.5 Crore, profit after tax, for Q2 FY25 12 November 2024
NATCO recorded consolidated total revenue of INR 1434.9 Crore for the second quarter of FY2025 that ended on 30th September 2024, as against INR 1060.8 Crore for the same period last year, reflecting a growth of 35.3%. The net profit for the period, on a consolidated basis, was INR 676.5 Crore as against INR 369.0 Crore same period last year, showing robust growth of about 83%.
The company has shown continued strong growth during the second quarter driven by exports formulation business and stable domestic pharma business.
The Board of Directors has declared second interim dividend of INR 1.50 per equity share, for FY 2024-25.
Celgene Corporation, Bristol Myers Squibb Company Withdraws Claims Against Breckenridge Pharmaceutical Inc. and NATCO Pharma 21 December 2023
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) vide its disclosure dated 8th
September 2023, has informed that Celgene Corporation, Bristol Myers Squibb Company,
Breckenridge Pharmaceutical Inc. and Natco Pharma Limited have been named defendants in
an antitrust lawsuit in the US by Louisiana Health Service & Indemnity Company D/B/A Blue
Cross and Blue Shield of Louisiana and HMO Louisiana, Inc., regarding Pomalidomide
(POMALYST) capsules.
The plaintiffs voluntarily dismissed Breckenridge Pharmaceutical Inc. and Natco Pharma
Limited from the case. All claims against the Company in the litigation have now been
dismissed.
Breckenridge is the ANDA holder and front-end marketing partner for the Pomalidomide
capsules generic product in the US.
Natco’s Pomalidomide capsules generic product has not yet launched in the US.
NATCO announces the Launch of additional strengths for the Generic Version of Revlimid® (lenalidomide capsules), in the USA 10 March 2023
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces the launch of
additional strengths for the generic version of Revlimid® (lenalidomide capsules), in 2.5
mg, and 20 mg strengths, in the United States, through its marketing partner Teva
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.
With this launch the companies made available all the strengths of lenalidomide in the
US market. Lenalidomide capsules are a prescription medicine used in adults for the
treatment of multiple myeloma.
Revlimid® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company
NATCO Announces Launch of First Generic Version of Nexavar® (Sorafenib) Tablets in the U.S. Market 01 June 2022
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of the first generic version of Nexavar® (Sorafenib) Tablets in 200 mg strength today in the U.S. market. The product will be launched by NATCO’s commercial partner Viatris, a global pharmaceutical company.
Sorafenib is prescribed for treatment of unresectable Hepatocellular Carcinoma (HCC), advanced Renal Cell Carcinoma (RCC) and Differentiated Thyroid Carcinoma (DTC). For more information refer to the full prescribing information or other medical resources.
Nexavar® registered sales of USD 69.7 million for the year ending December 2021 as per industry sales data.
Nexavar ® is a registered trademark of Bayer Healthcare Pharmaceuticals Inc. All brand names and trademarks are the property of their respective owners.
Investec India invites you to Natco Pharma Q3 FY22 Earnings call 10 February 2022
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Executive Vice President – Crop Health Sciences) will represent NATCO Pharma on the call. The call is scheduled for Tuesday, February 15th, 2022 at 11 am. It would run for an hour.
Click here for more information
NATCO announces License Agreement with the Medicines Patent Pool 20 January 2022
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a non-exclusive licenses agreement with the Medicines Patent Pool (MPP), Switzerland. MPP had taken license from Merck Sharp & Dohme Corp. (MSD), USA for the same.
Natco with this license agreement can manufacture and sell Molnupiravir Capsules 200 mg. for Indian market, which will be sold under brand name MOLNUNAT ® for treatment of Covid 19 infection with Sp02>93% and who have high risk of progression of the disease including hospitalization or death.
This agreement allows Natco to expand access to Covid-19 medicines in 105 countries in generic name. Under the license, Natco can set its own price for the generic products it produces, paying a royalty on sales to MSD. MSD, Ridgeback Biotherapeutics and Emory University will not receive royalties for sales of Molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.
NATCO Pharma Limited has been awarded Corporate Governance Award 07 January 2022
NATCO Pharma Limited (the Company) pleased to inform that the Company has been awarded Corporate Governance Award for the year 2021 at the virtual event held on January 6, 2022 organised by Moneylife Foundation, a non-profit organisation registered with the Charity Commissioner of Mumbai in the year 2016. Our Company has been selected from the nominations that it had received on its own from Moneylife readers, many top investors, analysts, fund managers, bankers, academics, and researchers. The award was presented by Sri M. Damodaran, former Chairman of SEBI.
The jury for selection of Corporate Governance Award for the first time are Sri R Balakrishnan, Prof. JP Singh (from IIM Ahmedabad – Retd.), Sri Gautam Bafna, Founder and CEO of Wisdom Torch Consulting Solutions LLP and Deputy Editor Sri Yogesh Sapkale as Member-Secretary. The framework and evaluation template to judge the 35 Companies under standard parameters are Statutory compliance, board composition and functioning, communication with shareholders, shareholder-related actions, ownership structure, related-party transactions, extraordinary gestures, investor perception, etc.
NATCO completes acquisition of Dash Pharmaceuticals LLC 01 January 2022
NATCO Pharma Inc. USA, a wholly owned subsidiary of NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) (“NATCO”), has completed the acquisition of Dash Pharmaceuticals LLC (“Dash”), a New Jersey based entity. Pursuant to this, Dash will become a 100% wholly owned subsidiary of NATCO Pharma Inc. and a step-down subsidiary of NATCO. The acquisition amount paid is US$ 18 million.
Dash is a front-end pharmaceutical sales, marketing and distribution entity in the USA which is expected to have Net Sales of approximately USD 15 million for the financial year ending December 2021.
This acquisition provides NATCO with a platform to engage with its customers directly in the USA which is the largest pharmaceutical market in the world
NATCO receives approval for the drug for the treatment of Covid-19 in India 28 December 2021
Natco Pharma Limited {NSE: NATCOPHARM; BSE: 524816) has received approval for Covid 19 drug Molnupiravir Capsules 200 mg. for Indian market, which will be sold under brand name MOLNUNAT ®. Molnupiravir is the first Covid drug authorized by Drugs Controller General {India) (DCGI) for the treatment of Covid 19 infection with Sp02>93% and who have high risk of progression of the disease including hospitalization or death. This capsule was earlier approved in United Kingdom and United States of America.
MOLNUNAT will be marketed by Natco and will be priced affordably. Molnupiravir is the first Covid drug available in Indian market with a minimal dosage duration of 5 days with promising viral clearance. Phase 3 trials of Molnupiravir has shown significant reduction in hospitalization of Covid 19 patients.
NATCO proposes to acquire Dash Pharmaceuticals LLC 14 December 2021
NATCO Pharma Limited through its affiliates is proposing to enter into an agreement to acquire Dash Pharmaceuticals LLC ("Dash") subject to satisfactory completion of due diligence, execution of definitive agreements and compliance with statutory requirements. Dash is a front-end pharmaceutical sales, marketing and distribution entity based in New Jersey, USA which is expected to have approximate net sales of USD 15 million for the year ending December 2021.
This acquisition provides NATCO with a front-end to engage with its customers directly in the USA which is the largest pharmaceutical market in the world.
NATCO launches Tipanat tablets in India, for the treatment of advanced colorectal and gastric cancer 18 November 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has launched a novel fixed-dose combination of Trifluridine + Tipiracil for the first-time in India under the brand name Tipanat as a pack of 20 tablets in a bottle. Tipanat is a novel antineoplastic nucleoside analog indicated for the treatment of advanced colorectal and gastric cancer.
In India, approximately 1,25,000 new cases of the above-mentioned cancers are reported every year. Tipanat is of high importance in not only extending the survival but also in preserving the quality of life in the late lines of treatment which is currently an unmet medical need. NATCO has offered Tipanat at an affordable price.
NATCO records INR 415.2 Crore consolidated revenue and INR 65.1 Crore of profit. after tax, for the Second Quarter, FY2021-22 11 November 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 415.2 Crore for the Second quarter ended on 30th September, 2021,
as against INR 827.90 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 65.1 Crores as against INR 203.90 Crore same period last year. The decline in revenue and profits compared to last year quarter is primarily due to a one-off contribution in prior
period earnings.
The company is poised for growth during latter half of this financial year and confident of a strong rebound in business. During this quarter, Lenalidomide product in Canada and Everolimus higher strength product in USA were launched. The revenues from these products will be realized in immediate quarters. The company is well prepared for its major launch of Lenalidomide in USA during Q4 of this financial year.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue in INR crores, Q2 FY22 |
| API |
76.3 |
| Formulations, Domestic |
99.8 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
190.5 |
| Other Operating income & non-operating income |
45.1 |
| Crop Health Sciences (CHS) |
3.5 |
The Board of Directors has recommended a second interim dividend of INR 0.5 per equity share of
INR 2.0 each, for FY 2021-22
Investec invites you to the Q2 FY22 Earnings call of Natco Pharma Limited 09 November 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Executive Vice President – Crop Health Sciences & Head – Investor Relations) will represent NATCO Pharma on the call. The call is scheduled for Friday, November 12th, 2021 at 11 am. It would run for an hour.
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NATCO announces launch of its 10mg strength for Everolimus Tablets (generic for Afinitor®) in the US market 01 October 2021
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816: Announces today that its marketing partner Breckenridge Pharmaceutical, Inc., US has launched the 10mg strength of Everolimus Tablets (generic for Afinitor®) in the US market. The U.S. Food and Drug Administration previously granted final approval of this Abbreviated New Drug Application. According to industry sales data, the 10mg strength of Afinitor generated annual sales of $392 million during the twelve months ending July 2021. Breckenridge previously launched Everolimus tablets in 2.5mg, 5mg and 7.5mg strengths during the first quarter of 2021 in the US market.
*All brand names and trademarks are the property of their respective owners.
Natco Pharma (Canada) Inc. announces the launch of PrNAT-LENALIDOMIDE Capsules, the first generic alternative to Revlimid® 02 September 2021
Natco Pharma (Canada) Inc., a subsidiary of Natco Pharma Limited, announced today the launch of Pr NAT-LENALIDOMIDE Capsules, the first generic alternative to Revlimid® to be approved by Health Canada.
PrNAT-LENADLIDOMIDE is used in combination with dexamethasone for the treatment of multiple myeloma in patients who are not eligible for stem cell transplant. PrNAT-LENALIDOMIDE is also indicated for treatment of transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion of 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
“We are proud to have led the way for an accessible treatment option for multiple myeloma that may alleviate the financial burden for myeloma patients, as well as public and private payers,” said Glenn Ikeda, Ph.D., CEO of Natco Pharma (Canada) Inc. “Our team has been working diligently to improve the supply of accessible, high-quality medicines to Canadian patients. The launch of PrNAT-LENALIDOMIDE represents an important milestone in Natco’s continued efforts to expand its product portfolio and is the result of considerable Canadian investment that will bring cost savings to healthcare at a critical time.”
Sales of oncology medicines have nearly tripled over the past decade with a shift towards higher-cost drugs. Multiple myeloma, commonly referred to as myeloma, is a cancer of plasma cells and the second most common form of blood cancer. Patients with this type of cancer may have low blood cell counts and immune problems giving them a higher chance for getting infections such as pneumonia. The bones can be affected leading to bone pain and breaks (fractures).
About 7,400 Canadians are living with or are in remission from myeloma and every day, nine Canadians are diagnosed with the disease. To date there is no cure for myeloma, however several types of treatments help control the disease.
“As a self-administered capsule, lenalidomide is an important therapy for Canadian patients whose lives are critically impacted by a variety of myeloma-related events and symptoms. This treatment aims at prolonging survival and improving quality of life. The availability of NAT-LENALIDOMIDE as the first generic alternative to Revlimid® is excellent news,” commented Joe Kamel, Registered Pharmacist, at Pure Health Pharmacy in Barrie, Ontario.
r NAT-LENALIDOMIDE is available through the RevAid® risk management plan in strengths of 2.5 mg, 5mg, 10 mg, 15 mg, 20 mg and 25 mg capsules.
NATCO records INR 427.30 Crore consolidated revenue and INR 75 Crore of profit, after tax, for the first quarter ended 30th June 2021 12 August 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 427.30 Crore for the quarter ended on 30th June 2021 as against INR 582.10 crores for Q1, FY 2020. The net profit after tax for the period, on a consolidated basis, was INR 75 Crore as against INR 122.10 crores for same quarter in the last financial year.
The degrowth in sales can be partially attributed to the higher proportion of initial phase of pandemic exports to USA in Chloroquine Phosphate tablets and Oseltamivir Phosphate capsules in the revenues for the quarter ended 30th June 2020.
The pandemic continues to impact the revenues of the company but recovered compared to quarter ending March 2021.
The Company has strong product launches both in Export markets and domestic India business during the current financial year and expects to have good growth.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue in INR crores, Q1 FY22 |
| API |
61.6 |
| Formulations, Domestic |
200.6 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
145.4 |
| Other Operating income & non-operating income |
19.2 |
| Crop Health Sciences (CHS) |
0.5 |
The Board of Directors has recommended an interim dividend of INR 2.0 per equity share of INR 2.0 each, during the First Quarter of FY 2021-22.
Investec invites you to the Q1 FY22 Earnings call of Natco Pharma Limited 09 August 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, August, 12, 2021 at 6.00 PM and would run for an hour.
Click here for more information
NATCO transfers Lenalidomide ANDA to Arrow 04 August 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces that it has transferred the Lenalidomide Capsules ANDA (2.5mg, 5mg, 10mg, 15mg, 20mg and 25mg strengths) to Arrow
International Limited as per an earlier agreement between the parties.
This transfer of the ANDA to Arrow does not materially change any of the terms of the agreement between the parties.
Arrow International Limited (an affiliate of Teva Pharmaceutical Industries Ltd) is the marketing partner of NATCO for this product in the US market. The ANDA was approved by USFDA in May 2021 with final approval in the 5mg, 10mg, 15mg, and 25mg strengths, and tentative approval in the 2.5mg and 20mg strengths.
Legal Update 07 July 2021
Natco Pharma Limited (NSE:NATCOPHARM, BSE: 524816} states that the Hon'ble High Court of Delhi has today orally pronounced judgment in the interim injunction application filed by FMC Corporation on CTPR. The Hon'ble Court said that it has allowed the application of FMC Corporation. The full copy of the Judgment is yet to become available. Natco will review all its options after the full Judgment becomes available to it.
NATCO records INR 2155.7 Crore consolidated revenue and INR 442.4 Crore of profit, after tax, for the full year ended March 2021 17 June 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2155.7 Crore for the year ended on 31st March, 2021, as against INR 2022.4 Crore for the last year, reflecting a revenue growth of 6.6 %, year-over-year. The net
profit for the period, on a consolidated basis, was INR 442.4 Crore, as against INR 458.1 Crore last year, showing a slight decline of 3.4%.
For the fourth quarter (Q4) ended March 31st, 2021, the company recorded a net revenue of INR 359.7 Crore, on a consolidated basis, as against INR 477.2 Crore during Q4, FY20. The profit after
tax, on a consolidated basis, was recorded as INR 53.0 Crore for the quarter, as against INR 93.2 Crore same quarter last year.
In spite of significant negative impact of the pandemic on the base business, the company was able to sustain its revenue during the year. The company expects strong growth during the current year due to multiple high value product launches in the USA, rebound in domestic India
business with new products and contribution from Crop Health division.
Segmental Revenue Split (All Figures in INR Crore)-
| Segment |
Revenue, Q4FY21 |
Revenue, Full Year FY21 |
| API |
70.8 |
512 |
| Formulations, Domestic |
81.8 |
410.2 |
| Formulations, Exports (incl. Profit Share &Foreign Subs) |
158.8 |
1077.1 |
| Other operating income& non-operating income |
47 |
154.3 |
| Crop Health Sciences |
1.3 |
2.1 |
Investec invites you to the Q4 FY21 Earnings call of Natco Pharma Limited 15 June 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, June, 18, 2021 at 11.00 AM and would run for an hour.
Click here for more information
NATCO receives approval for Carfilzomib Vials ANDA (generic for KYPROLIS® ) in the US market 14 June 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for
KYPROLIS®), from the U.S. Food and Drug Administration (USFDA).
The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. Based on the ANDA filing date NATCO believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch.
In the year 2019, the parties have reached a Settlement Agreement on para IV litigation related to the product with Onyx Therapeutics, Inc. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic carfilzomib products on a date that is held as confidential in the year 2027 or sooner depending on certain occurrences.
As per industry sales data, KYPROLIS® had generated annual sales of $696million during the twelve months ending December 2020 in the US. 10mg strength alone generated sales of $63million for the same period
NATCO receives USFDA approval for Lenalidomide Capsules 22 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5mg, 10mg, 15mg, and 25mg strengths, from the U.S. Food and Drug Administration (FDA), and the tentative approval of the 2.5mg and 20mg strengths.
NATCO, along with its marketing partner Arrow International Limited (a U.S. affiliate of Teva Pharmaceutical Industries Ltd), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID®. NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.
NATCO receives final approval for Everolimus tablets (generic for ZORTRESS9 ) in the US market 22 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for ZORTRESS ®),from the U.S. Food and Drug Administration (USFDA).
NATCO's partner BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the
product shortly.
The above strengths of Everolimus are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver Transplantation. As per industry sales data, ZORTRESS® and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.
NATCO starts Phase-III Clinical Trial of Molnupiravir capsules for Covid-19 treatment 21 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has initiated Phase-III clinical trial of Molnupiravir capsules in India. Its first patient was dosed today in Yashoda Hospitals, Hyderabad.Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response within five days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.
Phase-III clinical trial is initiated to evaluate the efficacy and safety of Molnupiravir
Capsules in mild COVID-19 patients. NATCO’s clinical trial is planned in 32 hospitals across India. A few established hospitals locally include Yashoda Hospitals,
Gleneagles Global Hospitals, KIMS Hospital in Secunderabad and Vizag, and Excel
Hospital, where the trial is being conducted
NATCO signs Voluntary Licensing Agreement with Lilly for Baricitinib for Covid-19 in India 17 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to
announce the signing of a royalty-free, non-exclusive, voluntary licensing agreement with Eli Lilly and Company, for the manufacture and commercialization of the drug Baricitinib for Covid-19 indication in India. In line with the licensing agreement, Natco has withdrawn its application filed with the Indian Patent Office, seeking Compulsory License against Lilly for Baricitinib for Covid-19 in India.
NATCO had earlier received an emergency use authorization for Baricitinib tablets, from Central Drugs Standard Control Organization (COSCO), for use in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
NATCO receives Emergency Use approval for Baricitinib tablets for Covid-19 treatment 03 May 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir, is used for treatment of COVID-19 positive patients.
Natco will be requesting a Compulsory License based on emergency use and in light
of the grave and serious public health emergency across India due to the Pandemic. The company is ready to launch the product this week, so as to make the product available to suffering patients across India
NATCO seeks Emergency approval of Molnupiravir capsules for Covid-19 treatment 26 April 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has applied to the Central Drugs Standard
Control Organization (CDSCO) in India for approval of Phase-III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 positive patients.
Pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Patients treated with Molnupiravir achieved response
within 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.
NATCO is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients. “Compassionate use” approval is given for investigational drugs so a patient with
an immediately life-threatening condition can gain access to the drug. The company is ready to launch the product this month if approval is given.
NATCO receives tentative approval for Ibrutinib tablets (generic for IMBRUVICA ®) ANDA in the US market 12 April 2021
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for our Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA®), from the U.S. Food and Drug Administration (USFDA).
Based on our ANDA filing date and the approval timeline, NATCO believes that we are eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form of the product
at the time of launch.
As per industry sales data, IMBRUVICA® (Tablet and Capsule dosage forms) had generated annual sales of $3.7 billion during the twelve months period ending December 2020 in the US market, of this, all the
strengths of IMBRUVICA® Tablets alone generated sales of $3.0 billion during the same period.
NATCO forays into Pheromone based technology for Integrated Pest Management 15 March 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its foray into Pheromone based mating disruption technology for Integrated Pest Management (IPM) solution to farmers in India. NATCO through its Crop Health Science (CHS) division is working with ATGC Biotech Pvt Ltd (ATGC) for the technology. ATGC is a science based innovative technology company concentrating on developing new biosafe molecules and tools to protect diverse crops from insect pests, in collaboration with US based agricultural biotech company ISCA Inc.
During Kharif 2021, NATCO plans to launch its first Green Label Pheromone product for Effective Management of Pink Bollworm (PBW) in cotton crop, under its brand NATMATE PBW. This is the first pheromone-based indigenously manufactured product for mating disruption that received approval from Central Insecticide Board (CIB). With this launch, cotton farmers will have a new and powerful tool to manage PBW.
Pink Bollworm posed a major challenge in the past few years to cotton farmers across India. The damage to quality and yield of cotton due to PBW is significant and often severely affects the livelihood of small farmers. Now, NATMATE PBW will be a tool in the hands of farmers and seed producers in developing an Insect Resistance Management (IRM) plan and preserve benefits of Bt traits in cotton as well.
NATCO receives final approval for Everolimus tablets (generic for Afinitor®) for the US market 08 March 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for Afinitor®) from the U.S. Food and Drug Administration (USFDA).
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks. The launch of 10 mg strength of the product is subject to confidential terms of a settlement and license agreement entered into with the owner of the Afinitor® brand.
The launch date of 10 mg strength of the product will be announced at a later date.
The above strengths of Everolimus are indicated in the treatment of breast cancer and a few other types of cancers. As per industry sales data, Afinitor® and its therapeutic equivalents had
generated annual sales of $712 million in USA during the twelve months ending December 2020.
*All brand names and trademarks are the property of their respective owners.
NATCO launches Brivaracetam tablets, in India, for treatment of epilepsy 26 February 2021
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of Brivaracetam tablets under brand BRECITA in India. Brivaracetam is indicated towards treatment of epilepsy.
Brivaracetam is developed by UCB Pharma and currently marketed in India by Dr Reddy’s under brand name Briviact®. NATCO’s BRECITA tablets will be available in two strengths of 50mg and 100mg at significantly lower MRP prices of INR 25/- and INR 35/- per tablet respectively. Epilepsy patients in India is estimated to be between 5-10 million, as per GEMIND guidelines.
NATCO records INR 386.0 Crore consolidated revenue and INR 63.4 Crore of profit, after tax, for the Third Quarter, FY2020-21 11 February 2021
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 386.0 Crore for the Third quarter ended on 31st December 2020, as against INR 513.0 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 63.40 Crore as against INR 104.4 Crore same period last year. The decline in revenue and profits was due to lower sales in domestic oncology and weak realization of profits from oseltamivir product in the USA.
Segmental Revenue Split (approx.), for Quarter 3 (All Figures in INR Crore)
| Segment |
Revenue, Q3 FY21 |
| API |
97.8 |
| Formulations, Domestic |
95.3 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
162.1 |
| Other Operating income |
5.9 |
| Other Income |
24.9 |
The Board of Directors has recommended a third interim dividend of INR 1/- per equity share of INR 2/- each.
Investec invites you to the Q3 FY21 Earnings call of Natco Pharma Limited 08 February 2021
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, February, 12, 2021 at 11.00 AM and would run for an hour.
Click here for more information
NATCO receives approval for Chlorantraniliprole (CTPR) - 1st key product of Crop Health Sciences Division 05 February 2021
Natco Pharma Limited (NSE : NATCOPHARM ; BSE: 524816) is pleased to announce its registration approval given by Central Insecticide Board & Registration Committee (CIB&RC) recorded in its Minutes of the 425th Meeting held on 25.01.2021, for indigenous manufacture of Chlorantraniliprole (CTPR) Technical 93.00% w/ w min. under Section 9(3) of Insecticides Act, 1968. NATCO would be the 1st indigenous manufacturer of this technical product.
CTPR technical is formulated into broad-spectrum insecticides used in several crops for better pest management. NATCO hopes to bring products based on CTPR shortly that would be affordable and accessible to farmers across India.
CTPR is an active ingredient used in products commercialized by FMC under brands Coragen® & Ferterra®. The sales generated from CTPR containing products in India, inclusive of third-party marketing companies, as per declaration given by FMC was estimated to be INR 1540 crores in 2016. NATCO believes the current market size to be over INR 2000 crores. NATCO has a pending litigation against FMC for declaration of freed om to use of CTPR.
NATCO launches anti blood clot tablet Rivaroxaban in India 17 December 2020
Natco Pharma Limited {NSE: NATCOPHARM; BSE: 524816) is pleased to announce the launch of
Rivaroxaban molecule, under brand RPIGAT. Rivaroxaban is an anticoagulant medication used
to treat and prevent blood clots. Rivaroxaban is currently sold by Bayer under brand name of
Xarelto®, in the lndianmarket.
After successful previous launches of DABIGAT (Dabigatran) and AP IGAT (Apixaban) by NATCO,
this latest Rivaroxaban NOAC (Novel oral anti-coagulant) is in line with our Company's mission of
affordable medicines accessible to all. NATCO has launched RPIGAT in four strengths- 20 mg, 15
mg, 10 mg and 2.5 mg. The 20 mg strength is priced at an MRP of INR 14.0 per tablet.
NATCO records INR 827.90 Crore consolidated revenue and INR 203.90 Crore of profit, after tax, for the Second Quarter, FY2020-21 12 November 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 827.90 Crore for the Second quarter ended on 30th September, 2020, as against INR 518.90 Crore for the same period last year, reflecting 59.5% growth. The net profit for the period, on a consolidated basis, was INR 203.90 Crores as against INR 117.7 Crore same period last year, showing a growth of 73.2%.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)-
| Segment |
Revenue, Q2 FY21 |
| API |
199.7 |
| Formulations, Domestic |
108.3 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
482.0 |
| Other Operating income |
10.7 |
| Other Income |
27.2 |
The Board of Directors has recommended a second interim dividend of INR 3.0 per equity share of INR 2.0 each, for FY 2020-21.
Axis Capital Limited invites you to the Q2 FY21 Earnings call of Natco Pharma Limited 06 November 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Friday, November, 13, 2020 at 11.00 AM and would run for an hour.
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NATCO announces launch of breast cancer medicine Lapatinib Tablets in the U.S. 30 September 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner, Lupin Limited (Lupin), has launched Lapatinib Tablets, 250 mg, in the United States market after NATCO received the final approval for its Abbreviated New Drug Application (ANDA) from the U.S. Federal Drug Administration (USFDA). NATCO was the 1st ANDA applicant for Lapatinib Tablets, 250mg, containing a Paragraph IV certification.
Lapatinib Tablets, 250mg, is sold under Brand name TYKERB®, of Novartis Pharmaceuticals Corporation (Novartis), which is indicated primarily for the treatment of certain types of breast cancer. For the 12 months ending June, 2020, TYKERB® had sales of approximately USO 61 million in the U.S. (IQVIA MAT June 2020).
NATCO records INR 582.1 Crore consolidated revenue and INR 122.1 Crore of profit, after tax, for the First Quarter, FY2020-21 12 August 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 582.1 Crore for the first quarter ended on 30th June, 2020, as against INR 513.3 Crore for the same period last year, reflecting an increase of 13.4%. The net profit for the period, on a consolidated basis, was INR 122.1 Crores as against INR 142.8 Crore same period last year, showing a decline of about 14.5%.
Increase in revenue was driven primarily by exports formulations business. During the quarter, the company faced margins pressure on both domestic and international formulations. In spite of lower margins during the first quarter, the company is confident of its business for remaining part of the financial year based on the order book and earnings outlook. The company expects a growth of over 25% in its earnings for FY2020-21 compared to prior year.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)
| Segment |
Revenue, Q1 FY21 |
| API |
143.92 |
| Formulations, Domestic |
125.62 |
| Formulations, Exports (incl. Profit Share & Foreign Subs) |
274.23 |
| Other Operating income |
18.35 |
| Other Income |
19.95 |
The Board of Directors has recommended an interim dividend of INR 1.25 per equity share of INR 2.0 each, during the First Quarter of FY2020-21.
Axis Capital Limited invites you to the Q1 FY21 Earnings call of Natco Pharma Limited 05 August 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, August 13, 2020 at 11.00 AM and would run for an hour.
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NATCO settles on Lenalidomide for Canada 10 July 2020
Natco Pharma (Canada) Inc., Canada, a subsidiary of Natco Pharma Limited has entered into a settlement agreement with Celgene (now part of Bristol-Myers Squibb) for the product Lenalidomide Capsules in Canada. The terms of the agreement are confidential as per the agreement.
NATCO records INR 2,022.4 Crore consolidated revenue and INR 458.1 Crore of profit, after tax, for the full year ended March 2020 17 June 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,022.4 Crore for the year ended on 3Pt March, 2020, as against INR 2224.7 Crore for the last year, reflecting a decline of around 9%, year-over-year. The net profit
for the period, on a consolidated basis, was INR 458.1 Crore, as against INR 642.4 Crore last year, showing a decline of about 29%.
For the fourth quarter (Q4) ended March 31, 2020, the company recorded a net revenue of INR 477.2 Crore, on a consolidated basis, as against INR 486.7 Crore during Q4, FY 2019. The profit after tax, on a consolidated basis, was recorded as INR 93.2 Crore for the quarter, as against INR 120.4 Crore same quarter last year.
The overall decline in revenue and profits, from prior year, was primarily due to continued decline in Hepatitis C product portfolio and to an extent in oncology segment due to pricing pressures.
The company also faced slowdown in business operations during the fourth quarter due to supply chain issues amidst Covid-19 concerns, which were subsequently resolved.
Segmental Revenue Split (approx.), as below (All Figures in INR Crore)
| Segment |
Revenue, Q4 FY20 |
Revenue, FY20 |
| API |
96.4 |
355.2 |
| Formulations, Domestic |
102.6 |
540.5 |
| Formulations, Exports (incl. profit share) |
200.9 |
824.9 |
| Foreign Subsidiaries |
18.5 |
108.5 |
| Other Operating income |
20.2 |
69.5 |
| Other Income |
38.6 |
123.8 |
The Board of Directors has recommended a fourth interim dividend of INR 1.00 per equity share of INR 2/- each, resulting in a total dividend payout of INR 6.75 per equity share for the year.
Axis Capital Limited invites you to the Q4 FY20 Earnings call of Natco Pharma Limited 11 June 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, June 18, 2020 at 11.00 AM and would run for an hour.
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NATCO supports Columbia University's clinical trial of chloroquine phosphate to prevent symptomatic Covid-19 infections 22 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) reiterates its commitment in supporting a clinical trial to prevent symptomatic SARS-CoV-2 infections by donating Chloroquine Phosphate (CQ) Tablets through its marketing partner in the United States, Rising Pharmaceuticals, to a study conducted by Columbia University, New York.
After NATCO's recent donation to a global clinical trial conducted by the CROWN
(COVID-19 Research Outcomes Worldwide Network) Collaborative at the Washington University School of Medicine in St. Louis it has now committed to support the Phase 2 of a clinical trial at Columbia University. The trial aims to determine the effectiveness of CQ in preventing COVID-19 infection in healthcare workers with moderate to high risk of exposure to the virus.
Researchers at Columbia University are conducting this critical study to assess CQ
as prophylaxis against COVID-19 in healthcare workers. The Phase 2 trial will enroll 350 volunteers who work in direct patient care roles at Columbia University Irving Medical Center and who have contact with patients who may have COVID-19 infection.
NATCO has been supplying CQ Tablets, a USFDA approved drug, through its marketing partner to the United States since 2011. Columbia University, a private Ivy League research university in New York City established in 1754 is renowned across the world for its expertise in conducting well designed clinical trials and NATCO is glad to work with them on this path breaking trial.
NATCO's Vizag Formulation facility receives EIR 20 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection and receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its drug formulations manufacturing facility at Visakhapatnam (Vizag) Andhra Pradesh, India, for an inspection conducted during the period from 24th March to 30th March, 2020.
NATCO's Chloroquine for International Study to prevent SARS-CoV-2 infection In Frontline Healthcare Workers 19 May 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has donated
Chloroquine Phosphate Tablets through its marketing partner in the United States,
Rising Pharmaceuticals, to support a global clinical trial conducted by the CROWN
Collaborative, for Protecting Essential Healthcare Workers from COVID-19 virus.
Washington University School of Medicine in St. Louis is the clinical coordinating
center for this ambitious international trial.
The group, called the COVID-19 Research Outcomes Worldwide Network (CROWN)
Collaborative, is testing whether the antimalaria drug Chloroquine can prevent
COVID-19 infection or decrease its severity in front-line health-care workers. For
this study, Chloroquine will be donated to the U.S. arm of the Chloroquine
RepurpOsing to healthWorkers for Novel CORONAvirus mitigaTION (CROWN
CORONATION) clinical trial.
The Collaborative and the trial are funded by the COV/0-19 Therapeutics
Accelerator, an initiative with contributions from an array of public and
philanthropic donors, including Bill & Melinda Gates Foundation. Conducted at
multiple sites in North America, Europe, the UK and Africa, CROWN CORONATION
will evaluate the protective potential of weekly, twice weekly or daily doses of
Chloroquine, when compared with placebo, in frontline healthcare workers at high
risk of exposure to SARS-CoV-2. The trial aims to include at least 30,000 subjects
across the frontline healthcare workers.
NATCO has been supplying Chloroquine Phosphate Tablets, a USFDA approved
drug, through its marketing partner to the United States since 2011. More recently
NATCO's alternate facility in Vizag has also been approved to supply the same drug.
Chloroquine Phosphate Tablets are indicated predominantly for the treatment of
malaria.
There is an urgent need to identify a drug to protect essential healthcare workers
and NATCO is very glad to help battle this unprecedented crisis engulfing the world.
NATCO's Vizag formulation facility receives USFDA approval 28 April 2020
Natco Pharma Limited (NSE : NATCOPHARM; BSE: 524816) is pleased to
announce final approval of its 1st supplemental abbreviated new drug
application (sANDA) product from the U.S. Food and Drug Administration
(USFDA) filed from its new drug formulations facility in JNPC SEZ, Ramky
Pharma City, Visakhapatnam (Vizag), Andhra Pradesh, India.
The sANDA, submitted as " Prior Approval Supplement," provides for NATCO's
Vizag facility as an alternate site for manufacture of the approved drug product
for the US market.
NATCO receives establishment inspection report (EIR) for Kothur's formulation facility 25 April 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection with an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the pre-approval inspection conducted at its drug formulations facility in Kothur village, Telangana, India, during the period from 2nd March to 6th March, 2020.
USFDA completes inspection of NATCO’s Kothur formulation facility 06 March 2020
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a Pre-approval inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur village, near Hyderabad, India, which was conducted from 2nd March to 6th March, 2020.
At the end of the inspection, the facility received a single observation related to equipment qualification of a co-mill used in the process that had operating speed slightly outside the qualification range. The company believes that this is a minor observation and can be addressed within a short period of time.
The company will provide due justification and corrective action plan with in the next 15 working days to address this observation.
NATCO records INR 513.0 Crore consolidated revenue and INR 104.4 Crore of profit, after tax, for the Third Quarter, FY 2019-20 12 February 2020
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.0 Crore for the Third quarter ended on 31st December, 2019, as against INR 580.0 Crore for the same period last year. The net profit for the period on a consolidated
basis, was INR 104.4 Crore as against INR 159.3 Crore same period last year. The company continues to face margin pressures in its Hepatitis C portfolio.
| Segment |
Revenue
(INR crore)
Q3 FY20 |
| API |
92.5 |
| Formulations, Domestic |
152.2 |
| Formulations, Exports (incl. profit share) |
187.5 |
| Foreign Subsidiaries |
34.5 |
| Other Operating income |
17.1 |
| Other Income |
30.9 |
The Board of Directors has recommended a third interim dividend of INR 3.50 per equity share of INR 2/- each.
Axis Capital Limited invites you to the Q3 FY20 Earnings call of Natco Pharma Limited 10 February 2020
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Thursday, February 13, 2020 at 12.00 Noon and would run for an hour.
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NATCO files ANDA for Trifluridine/ Tipiracil Hydrochloride Tablets for the USA market 03 January 2020
Natco Pharma Limited (NSE:NATCOPHARM; BSE: 524816} is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Lonsurf® (Trifluridine/ Tipiracil) tablets (15mg/6.14mg and 20mg/8.19mg). NATCO believes that it is one of the first ANDA filers for the product and could be eligible for 180 days exclusivity under certain circumstances.
Lonsurf® has recorded sales of USD 150 million for the year ending December 20 18 in the US market as per IQVIA. The drug is currently indicated for certain forms of Colorectal and Gastric Cancers. Lonsurf® is a registered trademark of Taiho Oncology, INC.
Commercial Manufacturing Operations begin in NATCO's Visakhapatnam Formulation Facility 14 November 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its Finished Dosage Formulations (FDF) facility in Visakhapatnam has commenced commercial operations. The facility is a part of the Special Economic Zone (SEZ) and intended to cater primarily to the U.S. & other international markets.
Vizag facility is a key part of NATCO's capacity expansion plans for its pipeline of products and diversification into different geographies. From capability perspective, this facility will focus mostly on oral solid dosages (tablets and capsules), including a cytotoxic block for products in the oncology segment. An application with the U.S. Food and Drug Administration (USFDA) is already filed for site transfer of the first product & to trigger a regulatory audit. Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its Finished Dosage Formulations (FDF) facility in Visakhapatnam has commenced commercial operations. The facility is a part of the Special Economic Zone (SEZ) and intended to cater primarily to the U.S. & other international markets.
NATCO records INR 518.9 Crore consolidated revenue and INR 117.7 Crore of profit, after tax, for the Second Quarter, FY 2019-20 12 November 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded
consolidated total revenue of INR 518.9 Crore for the Second quarter ended on 30th September, 2019, as against INR 583.50 Crore for the same period last year. The net profit for the period, on a consolidated basis, was INR 117.7 Crores as against INR 181.6 Crore same
period last year. The decline in revenues and profits compared to the same period last year is primarily due to the anticipated drop in oseltamivir product sales in the USA and Hep C sales in India.
Segmental Revenue Split (approx.), for the Quarter 2, FY2019-20, as below:
| Segment |
Revenue (INR crore) Q2 FY20 |
| API |
68 |
| Formulations, Domestic |
122 |
| Formulations, Exports (incl Profit Share) |
225 |
| Foreign Subsidiaries |
27 |
| Other Operating income |
43 |
| Other Income |
34 |
The Board of Directors has recommended second interim dividend of INR 1.00 per equity share of INR 2.00 each.
NATCO's 1st key product in Crop Health Sciences for India - Chlorantraniliprole 11 November 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce a key technical product from its Crop Health Sciences (CHS) division for Chlorantraniliprole (CTPR), a broad spectrum insecticide used in several crops, and is hoping to bring formulations based on this product with affordability and accessibility to farmers across the country. NATCO is awaiting regulatory approval of the CTPR product.
CTPR is an active ingredient used in products commercialized by FMC under their brands Coragen® & Ferterra®. The sales generated from CTPR containing products in India, inclusive of third-party marketing companies, as per declaration given by FMC is estimated to be INR 1540 crores in 2016. NATCO has filed a suit for declaration of freedom to use of CTPR, at the City Civil Court, Hyderabad, in the month of September 2019. FMC has counter-sued before the Delhi High Court, in November 2019, claiming patent infringement
Edelweiss Securities invites you to the Q2 FY20 Earnings call of Natco Pharma Limited 06 November 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled for Wednesday, November 13, 2019 at 11.00 AM IST and would run for an hour.
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USFDA completes inspection of NATCO’s Mekaguda active pharmaceutical ingredient facility 12 August 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 5th August, 2019 to 9th August, 2019.
At the end of the inspection, the facility received six observations mostly procedural in nature. The company believes that none of observations are related to data integrity and that all the observations can be addressed within a short period of time.
Key points of the observations in Form 483 outlined below:
• Supplier & service provider agreements to be made more robust. Some procedural improvements in gowning section recommended.
• Employees engaged in the manufacturing and packaging areas require more effective training.
• Procedural improvements needed in process revalidation protocols and approval of alternate supplier sources.
• Visual stains were observed in some early stage reactors that need further diagnosis and improvement. ‘Status tags’ for certain drying process equipment were not to be found.
• Incident report not raised for software systemic error found in Karl-Fisher instrument in the QC lab.
• Procedural and handling gaps found in settling plate management in the microbiology lab.
The company will provide due justifications and corrective action plan within the next 15 working days to address the above USFDA observations.
NATCO records INR 513.3 Crore consolidated revenue and INR 142.8 Crore of profit, after tax, for the First Quarter, FY 2019-20 09 August 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 513.3 Crore for the first quarter ended on 30th June, 2019, as against INR 574.5 Crore for the same period last year, reflecting a decline of about 10.6%. The net profit for the period, on a consolidated basis, was INR 142.8 Crores as against INR 181.1 Crore same period last year, showing a decline of about 21%. Despite this periodic decline in profitability, the company remains confident on its outlook for the year and beyond.
However, the amount of INR 47.40 Crores (USD 6.83 million) received as upside sharing incentive from investor CX Securities is recognized as an increase in equity and not considered as income in Profit & Loss, as per applicable accounting framework.
Segmental Revenue Split (approx.), for the Quarter 1, FY2019-20, as below-
| Segment |
Revenue
(INR crore)
Q1 FY20 |
| API |
72 |
| Formulations, Domestic |
164 |
| Formulations, Exports
(incl. Profit Share) |
213 |
| Foreign subsidiaries |
28 |
| Other operating income |
16 |
| Other income |
20 |
The Board of Directors has recommended an interim dividend of INR 1.25 per equity share of INR 2.0 each, for the financial year FY2019-20.
NATCO receives establishment inspection report for Kothur facility 05 August 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful closure of inspection with the receipt of Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility in Kothur Village, Telangana, India, during the period May 30th – June 5th, 2019.
Edelweiss Securities invites you to the Q1 FY20 Earnings call of Natco Pharma Limited 05 August 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled on Friday, August 9, 2019 at 3.30 PM IST. It would run for an hour
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USFDA completes inspection of NATCO’s Chennai formulation facility 15 July 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful completion of regulatory inspection from the U.S. Food and Drug
Administration (FDA) for its Active Pharmaceutical Ingredient (API) facility in Chennai, India, conducted during the period July 8th – 12th, 2019. The regulatory
audit resulted in zero observations.
USFDA completes inspection of NATCO’s Kothur formulation facility 06 June 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur Village, near Hyderabad, India, which was conducted during the period 30th May, 2019 to 5th June, 2019.
At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.
Key points of the observations in Form 483 outlined below:
• Field Alert Report (FAR) was not submitted within three (3) days of receipt of information of failure of distributed batches to meet specifications. Although the out of specifications (OOS) result was invalidated, but FAR was not submitted within three (3) days of detection of OOS.
Out of trend results of a distributed batch were not extrapolated to obtain expected impurity value at the end of shelf life.
• Annual product reviews of one of the products were not approved in time.
• Visual inspection of products carried out as a part of investigation was not properly documented.
• SOP on manual interpretation of impurity peaks was made effective in November 2018, but the interpretation of impurity peaks performed prior to November 2018 were not reviewed for appropriateness and accuracy.
• Retest results performed by original analyst were considered for reporting rather than average of all retest results from the original and 2nd analyst.
• Documentation of chemical surface swabbing performed per cleaning validation on one of the products provides no description of each of individual sub swabbing samples performed for each sample location.
• Master Production and control records for one of the product does not include the operational parameters of peristaltic pumps used.
• Mechanical stirrer used in the manufacturing of one of the product does not have documented range or speed verification using a calibrated tachometer.
• Standard weights used to perform daily calibration of balances, or ferrous and non-ferrous metal test pieces used during qualification of metal detector are not traceable to a unique identification code in calibration logs.
The company will provide due justifications and corrective action plan within the next fifteen (15) working days to address the USFDA observations.
Natco files ANDA for Bosentan 32mg Tablets for the USA market 04 June 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension.
Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer®. NATCO believes that its ANDA is possibly the sole first-to-file based on the filing date. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product.
Tracleer® is indicated for the treatment of pulmonary arterial hypertension. As per Johnson & Johnson’s annual report, for the year ending 2018, Tracleer® had registered sales of approx. $268million in the US market, and the 32 mg is one strength that is indicated for pediatric patients.
NATCO settles generic Carfilzomib Injection Patent Litigation in the US market 30 May 2019
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it has reached a Settlement Agreement with Onyx Therapeutics, Inc. on patent litigation related to generic versions of 10mg, 30mg and 60mg of Kyprolis®. NATCO has partnered with Breckenridge Pharmaceutical, Inc., who will market the product in the United States.
The parties have reached a Settlement Agreement and the District Court case has been dismissed. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic carfilzomib product on a date that is held as confidential in 2027 or sooner depending on certain occurrences. The parties cannot make further comment as to the terms of the Settlement Agreement.
NATCO believes that its 10mg ANDA is sole first to file and could be eligible for 180-days marketing exclusivity for the 10mg strength under certain circumstances.
Kyprolis® reportedly had sales of USD 586 million for the year ending December 2018 in the United States.
Kyprolis® is a registered trademark of Onyx Therapeutics, Inc.
NATCO records INR 2,224.7 Crore consolidated revenue and INR 642.4 Crore of profit, after tax, for the full year ended March 2019 27 May 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,224.7 Crore for the year ended on 31st March, 2019, as against INR 2242.4 Crore for the last year, reflecting a slight decline of less than 1%, year-over-year. The net profit for the period, on a consolidated basis, was INR 642.4 Crore, as against INR 695.2 Crore last year, showing a decline of 7.6%.
For the fourth quarter (Q4) ended March 31st, 2019, the company recorded a net revenue of INR 486.7 Crore, on a consolidated basis, as against INR 787.9 Crore during Q4, FY 2018. The profit after tax, on a consolidated basis, was recorded as INR 120.4 Crore for the quarter, as against INR 299.7 Crore same quarter last year.
Although the revenue has been flat year-over-year, the marginal decline in profit was primarily due to write-off of Oseltamivir inventory by our marketing partner in the USA. The flu-season in USA was weaker than expected resulting in the write-off of this inventory valued at approximately US$ 5.5M. On the domestic business, in spite of intense price pressures, the company has seen growth in Oncology segment.
Segmental Revenue Split (approx.), for the full year, FY2018-19, as below-
| Particulars |
Amount |
|
(Rs.in crores) |
| API |
303 |
| Formulations, Domestic |
735 |
| Formulations, Exports (incl Profit Share) |
885 |
| Foreign Subsidiaries |
109 |
| Other Operating income |
63 |
| Other Income |
130 |
The Board of Directors has declared third interim dividend of INR 1.25 per equity share of INR 2/- each, resulting in a total dividend payout of INR 6.25 per equity share for the Financial Year 18-19.
Edelweiss Securities invites you to the Q4 FY19 Earnings call of Natco Pharma Limited 22 May 2019
Mr. Rajeev Nannapaneni (Vice Chairman and Chief Executive Officer) and Mr. Rajesh Chebiyam (Vice President, Acquisitions, Institutional Investor Management and Corporate Communications) will represent NATCO Pharma on the call. The call is scheduled on Tuesday, May 28, 2019 at 11.00 AM IST. It would run for an hour.
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Natco’s marketing partner Alvogen receives FDA approval for Nitroglycerin Sublingual Tablets 08 May 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner Alvogen has received the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg,
and 0.6 mg. Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
Pfizer Pharmaceuticals Ltd markets this drug under its brand Nitrostat® Sublingual Tablets in the same strengths mentioned above.
As per IQVIA data, Nitroglycerin Sublingual Tablets had total annual sales of around USD 77.3 million in the US market, for the year ending 2018.
Natco & its alliance partner Lupin receive FDA approval for generic Bosentan Tablets 02 May 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Bosentan tablets in the strengths of 62.5 mg and 125 mg. Bosentan is used for the treatment of patients with pulmonary arterial hypertension.
The tablets of Natco marketing by its partner Lupin are a generic version of Actelion Pharmaceuticals Ltd’s Tracleer® tablets in the same strengths.
As stated by our partner, Lupin, as per IQVIA MAT March 2019 data, Bosentan tablets 62.5 mg and 125 mg had an annual sales of around USD 84.8 million in the US market.
NATCO and its alliance partner Lupin receive FDA approval for lmatinib Mesylate Tablets 06 March 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for lmatinib Mesylate Tablets, 100 mg (base) and 400 mg (base). These Tablets will be marketed in the USA by Natco’s marketing partner Lupin, as generic versions of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec® Tablets, 100mg and 400mg.
lmatinib Mesylate Tablet is indicated primarily for the treatment of patients with specific types of Chronic Myeloid Leukemia (CML). Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately USD 655 million in the US (IQVIA MAT December 2018).
NATCO records INR 580.0 Crore revenue and INR 159.3 Crore of Profit, after tax, for the Third Quarter, FY 2018-19 12 February 2019
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenues of INR 580.0 Crore for the quarter ended on December 31, 2018, as against INR 573.6 Crore during the same quarter last year.
The net profit for the period, on a consolidated basis, was INR 159.3 Crore, as against INR 217.4 Crore same quarter last year. The decline in profits during the quarter compared to last year was predominantly due to margin reduction of Oseltamivir in the USA market.
Revenue Split (approx.) for Quarter 3, FY2019- API - INR 99 Cr
Formulations, Domestic - INR 164 Cr
Formulations, Exports (incl Profit Share) - INR 257 Cr
Foreign Subsidiaries - INR 25 Cr
Other Operating & Other Income - INR 35 Cr
The Board of Directors has recommended an interim dividend of INR 3.50 per equity share of INR 2/-each.
Edelweiss Securities invites you to the Q3 FY19 Earnings call of Natco Pharma Limited 05 February 2019
Mr. Rajeev Nannapaneni (Vice Chairman and CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q3 FY2019 Earnings Conference Call on Wednesday, February 13th, 2019 at 12 PM IST hosted by Edelweiss Securities.
Click here for more details.
NATCO and Alvogen file ANDA for Ibrutinib Tablets for the USA market 31 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica® Tablets).
NATCO and its co-development & marketing partner, Alvogen Pine Brook LLC, USA, believe that the ANDA is possibly sole first-to-file based on the ANDA filing dates. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances.
In the United States Imbruvica® brand is owned and marketed by Pharmacyclics LLC and Janssen Biotech, Inc. Imbruvica® had U.S. Sales of approximately US$ 2.6 Billion for twelve months ending September, 2018, according to data from IQVIA. As per the last tracked prescription sales, almost 83% of the sales contribution has come from the above mentioned tablet dosage forms.
NATCO launches Valsartan-Sacubitril tablet in INDIA at an affordable price, under its brand VALSAC 28 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched Valsartan-Sacubitril tablet at an affordable price, under its brand VALSAC. Valsartan-Sacubitril is a combination drug used for certain types of heart failure, and works by relaxing blood vessels, making it easier for the heart to pump blood to the body.
NATCO has launched VALSAC in 50 mg & 100 mg strengths at an MRP of INR 45.0 and INR 55.0, per tablet, respectively
NATCO initiates Greenfield Facilities for Niche Agrichemical Business 25 January 2019
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has initiated work on green-field manufacturing facilities for producing Niche Agrichemical products in the Nellore District of Andhra Pradesh. These facilities will manufacture both Agrichemical Technical and Formulation products.
Natco strongly believes that its pharma strength in chemistry coupled with an acumen towards selection of niche molecules would differentiate itself in the Agrichemical space as well. Natco expects the facilities in Nellore district to be commissioned by end of 2019 with a total capital expenditure of INR 100 crores.
NATCO records INR 583.40 Crores consolidated revenue and INR 181.50 Crore of profit, after tax, for the Second Quarter, FY 2018-19 05 November 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 583.40 Crore for the second quarter ended on 30th September, 2018, as against INR 432.20 Crore for the same period last year, reflecting a growth of 35%. The net profit for the period, on a consolidated basis, was INR 181.60 Crores as against INR 84.40 Crore same period last year, showing a growth of 115%.
During the quarter, the company has witnessed growth in the formulations business- both domestic and exports. The breakup of revenues has Formulations domestic Rs. 193.87 crores, Formulation exports including profit share/service income Rs. 247.81 crores, API revenues Rs. 66.81 crores, other operating / other income Rs.53.61 crores and subsidiary revenues Rs. 21.40 crores for quarter ended 30th September 2018.
Notice of Board Meeting – November 5th, 2018 29 October 2018
This is to inform you that the meeting of the Board of Directors of the Company is scheduled to be held on Monday, the 5th day of November, 2018 at 10.30 a.m. at the Registered Office of the Company to consider the following, among other things:
1. Approval of the unaudited financial results, both on standalone and consolidated basis for the quarter and half-year ended 30th September, 2018.
2. Consideration of buy-back of equity shares of the Company and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 11.15 a.m on 29th October, 2018 to 7th November, 2018 (both days inclusive). Trading window will be opened from 8th November, 2018.
CPhI Worldwide 2018 09 October 2018
The Business Development Team at CPhI worldwide 2018, held in Madrid, Spain. CPhI Worldwide, is an annual event which allows pharma companies to connect and network with their existing and potential worldwide partners.
Court Affirms Prior Decisions Finding Copaxone® 40 mg/ml Patents Invalid- a milestone for NATCO and its market ing partner Mylan 15 October 2018
NATCO Pharma Limited {NSE: NATCOPHARM; BSE: 524816) is pleased to announce that the United
States Court of Appeals for the Federal Circuit has affirmed the District of Delaware's decision that
Teva's Copaxone® 40 mg/ml dosing patents are invalid as obvious. The Federal Circuit also
affirmed today the final written decisions issued by the Patent Trial and Appeal Board (PTAB) in
three inter partes reviews filed by Natco's marketing partner, Mylan, related to the same patents.
These were the last remaining patent infringement cases Mylan was defending in the U.S. relating
to Glatiramer Acetate Injection 40mg/ml. Today's decisions are important milestones as we
continue to focus our efforts on meeting the needs of multiple sclerosis patients in the U.S. The
invalidated patents are U.S. Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776,
which are owned by Veda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals
Industries, Ltd.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in t he U.S. with brand
sales for the 20 mg/ml dose of approximately $527 million and for the 40 mg/ml dose of
approximately $2.86 billion for the 12 months ending Aug. 31, 2018, according to IQVIA.
Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial
MS diagnoses.
Dr.Reddy’s & NATCO file Doxorubicin Hydrochloride Liposome Injection in EUROPE 13 August 2018
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its codevelopment and marketing partner Dr. Reddy’s Laboratories Ltd. has filed for Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil®, for intravenous use, for the European Markets.
Janssen’s brand Doxil® is predominantly used for the treatment of metastatic breast cancer, advanced ovarian cancer and progressive multiple myeloma. The Doxil® brand, 2mg/ml, had sales of approximately US$130.5 Million, in Europe, for the 12 months ending December 31, 2017, according to Quintiles IMS.
NATCO records INR 574.5 Crores consolidated revenue and INR 181.1 Crore of profit, after tax, for the First Quarter, FY2018-19 08 August 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 574.5 Crore for the first quarter ended on 30th June, 2018, as against INR 448.7 Crore for the same period last year, reflecting a growth of 28 %. The net profit for the period, on a consolidated basis, was INR 181.1 Crores as against INR 93.7 Crore same period last year, showing a growth of 93 %.
The Board of Directors approved an Interim Dividend of Rs.1.50 (75%) per equity share of Rs.2/each.
Click here for the Quarter 1 results.
Edelweiss Securities invites you to the Q1 FY19 Earnings call of Natco Pharma Limited 01 August 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q1 FY 2019 Earnings Conference Call on Thursday, August 9th, 2018 at 11:00 AM IST hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting – August 8th, 2018 28 July 2018
A meeting of the Board of Directors of the Company is scheduled to be held on Wednesday, the 8th day of August 2018 at 11.00 a.m. at the Registered Office of the Company to consider, among other things, the following items of businesses and related matters:
1. Unaudited financial results for the quarter ended 30th June, 2018 along with the Limited Review Report thereon.
2. To Consider Interim Dividend, if any, for the year 2018-19.
3. Convening of 35th Annual General Meeting to be held for the financial year 2017-18.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 30th July 2018 to 10th August 2018 (both days inclusive). Trading window will be opened from 11th August 2018.
NATCO launches fixed dose combination of Sofosbuvir-Daclatasvir drug for Hepatitis C treatment in INDIA 02 July 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the first company in India to launch under its brand Hepcinat Plus, the generic fixed dose combination of Sofosbuvir 400 mg and Daclatasvir 60mg Tablet, for the treatment of patients with chronic hepatitis C virus (HCV) infection.
Natco has launched Hepcinat Plus at an MRP of INR 17,500/-, for a bottle of 28 tablets.
NATCO launches generic Posaconazole Injection- 1st time available in INDIA 08 June 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of Posaconazole Injection, 300 mg/16.7ml, under its brand POSANAT. This is the first time an injection version of this drug available in India. POSANAT will be available in 18.0 mg/ml strength, a formulation for intravenous (IV) use. Posaconazole Injection is sold in the USA market by Merck under its brand name of NOXAFIL ®.
Posaconazole injection is an antifungal agent & used in patients who are at high risk of developing infections due to being severely immunocompromised, such as associated with stem cell transplant or from chemotherapy.
NATCO records INR 2,242 Crore consolidated revenue and INR 695 Crore of profit, after tax, for the full year ended March 2018 23 May 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2,242.4 Crore for the year ended on 31st March, 2018, as against INR 2078.9 Crore for the last year, reflecting an year-over-year growth of 7 .87%. The net profit for the period, on a consolidated basis, was INR 695.2 Crore, as against INR 484.9 Crore last year, showing a growth of 43.37%.
For the fourth quarter (Q4) ended March 31st, 2018, the company recorded a net revenue of INR 787 .9 Crore, on a consolidated basis, as against INR 577.2 Crore during Q4, FY 2017, posting an increase of 36.50%. The profit after tax, on a consolidated basis, was recorded as INR 299.7 Crore for the quarter, as against INR 176.4 Crore same quarter last year, showing a growth of 69.90%.
The growth in revenue and profit during the year was driven primarily by formulations business in the USA that included niche generic product launches of Glatiramer Acetate, Liposomal Doxorubicin and Lanthanum Carbonate. Additionally, generic Oseltamivir sales in the USA was a strong contributor for the company in spite of competition. The domestic oncology formulations business continued to be strong during the year.
Click here for the full FY18 results.
Edelweiss Securities invites you to the Q4 FY18 Earnings call of Natco Pharma Limited 21 May 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q4 FY2018 Earnings Conference Call on Thursday, May 24th, 2018 at 11:00 AM IST hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting – May 23rd, 2018 16 May 2018
A meeting of the Board of Directors of the Company is scheduled to be held on Wednesday, the 23rd day of May, 2018 at 11.00 a.m. at the Registered Office of the Company to consider among other things, to approve the Audited Financial Results for the quarter and year ended 31st March, 2018 and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 16th May, 2018 to 25th May, 2018 (both days inclusive). Trading window will be opened on 28th May, 2018.
NATCO launches 1st generic version of Oral tablets for Multiple Sclerosis in INDIA 04 April 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the first company in India to launch a generic version of Teriflunomide, for the treatment of Relapsing and Remitting forms of Multiple Sclerosis (RRMS), under its brand DENOPSY. This is the first oral medicine for RRMS being offered in India at two different strengths- 14 mg & 7 mg tablets. Teriflunomide is sold by Sanofi-Genzyme under brand name of AUBAGIO®, in the USA market.
DENOPSY is priced attractively & much lower than other alternate options in India. As per WHO 2013 estimates, the number of patients suffering from Multiple Sclerosis in India is 5-20 per 1 lakh population.
NATCO announces USFDA filing for Sofosbuvir tablets, 400 mg 01 March 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that it has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the U.S. Federal Drug Administration (USFDA). Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi®.
Natco believes that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
For the 12 months ending Dec. 31, 2017, SOVALDI® had U.S. sales of approximately $130 million as per Gilead Sciences Inc. unaudited results released for the year ending 31st December, 2017.
USFDA completes inspection of Natco's Mekaguda API facility with zero observations 17 February 2018
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce successful completion of regulatory inspection from the United States Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, which was conducted during the period 12th February, 2018 to 16th February, 2018. The regulatory audit resulted in zero observations (no form 483 issued).
NATCO records INR 573.6 Crore revenue and INR 217.4 Crore of Profit, after tax, for the Third Quarter, FY 2017-18 06 February 2018
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenues of INR 573.6 Crore for the quarter ended on 31st December, 2017, as against INR 685.1 Crore during the same quarter last year. The decline in revenue compared to last year’s quarter was predominantly due to large stocking quantities of generic oseltamivir during last year’s period.
The company is very pleased to show strong earnings during the quarter, in spite of loss of exclusivity for generic oseltamivir in the USA market. We successfully launched several new products in the USA market recently, that includes generic versions of glatiramer acetate, oseltamivir suspension, liposomal doxurubicin and lanthanum carbonate, and continue to believe in strong growth in ensuing quarters. The net profit for the period, on a consolidated basis, was INR 217.4 Crore, as against INR 194.9 Crore same quarter last year, showing a growth of 11.5%.
Edelweiss Securities invites you to the Q3 FY18 Earnings call of Natco Pharma Limited 31 January 2018
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q3 FY2018 Earnings Conference Call on Wednesday, February 7th, 2018 at 9.30 AM IST hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting - February 6th, 2018 29 January 2018
A meeting of the Board of Directors of the Company is scheduled to be held on February 06, 2018, inter alia, to consider the following items of business:
1. The unaudited financial Results for the quarter and nine months ended December 31, 2017 (Q3) and related matters.
2. To consider Second Interim Dividend, if any, for the financial year 2017-18 and related matters etc.
Further, pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from January 29, 2018 to February 08, 2018 (both days inclusive). Trading window will be opened from February 09, 2018.
NATCO launches TAFNAT, Tenofovir Alafenamide tablets, for treatment of chronic hepatitis B, in INDIA 18 December 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is one of the first companies to launch a generic version of Tenofovir Alafenamide, TAF, 25 mg, a once-daily tablet for the treatment of chronic hepatitis B in adults, under its brand TAFNAT, in India. The drug TAF demonstrates comparable efficacy, with an enhanced renal and bone safety profile as compared to earlier formulation of tenofovir (tenofovir disoproxil fumarate).
TAFNAT is manufactured under license from Medicines Patent Pool (MPP) and Gilead Sciences. Natco priced its generic medicine of TAFNAT at an MRP of INR 1900/- for a monthly pack of 30 tablets for the India market.
Natco Closes QIP 14 December 2017
In respect of the QIP, the Committee of Directors at its meeting held today i.e. December 14, 2017 has inter alia approved allocation of 10,000,000 Equity Shares at the issue price of Rs. 915 per Equity (including a premium of Rs. 913 per Equity Share) upon the closure of the Issue, which is at a discount of 2.41% (i.e. Rs. 22.63) per Equity Share, to the Floor Price of Rs. 937.63 per Equity Share, determined as per the formula prescribed under Regulation 85(1) of the SEBI ICDR Regulations, for the Equity Shares to be allotted to eligible qualified institutional buyers pursuant to the QIP amounting to an Issue size of Rs. 9,150 million.
Click here for the
Placement Document
Natco’s investment in OMRV Hospitals Pvt.Ltd.(PACE Hospitals) 04 November 2017
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) would like to announce that today, it has executed definitive agreement and subscribed to 7.50% (seven decimal point five zero per cent) of the paid-up equity share capital of OMRV Hospitals Private Limited (OMRV). The investment amount was INR 7.50 crores (Rupees Seven crores and fifty lakhs).
OMRV operates under brand name of PACE Hospital which is a super specialty hospital presently operating in Hyderabad, Telangana focused on tertiary care services in the field of Medical and Surgical Gastroenterology, Hepatology, Nephrology, Urology, GI Oncology and Andrology.
Natco's marketing partner Alvogen first to market generic equivalent to Oseltamivir Phosphate powder for oral suspension in the USA 03 November 2017
Natco Pharma Limited (NSE: NATCOPHARMA; BSE: 524816) is pleased to announce that it's marketing partner Alvogen has received the final approval and is the first to market the generic equivalent to Oseltamivir Phosphate, 6 mg/ml powder for oral suspension in the United States. In December 2016, Alvogen launched the first generic equivalent to Oseltamivir Phosphate capsules in the United States.
NATCO records INR 432.2 Crore revenue for the Second Quarter, FY 2017-18 02 November 2017
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenues of INR 432.2 Crore for the quarter ended on 30th September, 2017, as against INR 471.1 Crore during the same quarter last year. The company had a one-time exclusive launch of generic oseltamivir during last year’s period.
The net profit for the period, on a consolidated basis, was INR 84.4 Crore, as against INR 66.2 Crore same quarter last year, showing a growth of 27.5 %.
Edelweiss Securities invites you to the Q2 FY18 Earnings call of Natco Pharma Limited. 31 October 2017
Mr. Rajeev Nannapaneni (CEO) & Mr. Rajesh Chebiyam (VP, Acquisitions, Institutional Investor Management & Corporate Communications) will be addressing investor queries in Natco Pharma Limited’s Q2 FY2018 Earnings Conference Call on Friday, November 3, 2017 at 11.00 AM IST hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting - November 2nd, 2017 25 October 2017
A meeting of the Board of Directors of the Company is scheduled to be held on Thursday, the 2nd day of November, 2017 at 11.00 a.m. at the Registered Office of the Company to consider, among other things, the following items of businesses and related matters:
1. Approval of the unaudited financial results, both on standalone and consolidated basis
for the quarter and half-year ended 30th September, 2017.
2. Approval for raising of funds through further issue of shares or convertible securities of any nature through one or more modes, including but not limited to a further public offer, rights issue, qualified institutions placement, issue of American depository receipts or global depository receipts etc. subject to such approvals as may be required.
3. Convening of Extraordinary General Meeting of the members of the Company to
approve such raising of funds.
Please further note that pursuant to the SEBI {Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 25th October, 2017 to 4th November, 2017 (both days inclusive). Trading window will be opened from 6th November, 2017.
NATCO’s marketing partner Mylan launches generic Glatiramer Acetate in the U.S. market - both 20 mg/mL and 40 mg/mL versions 05 October 2017
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that its marketing partner Mylan N.V., has launched in the U.S. the first Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection that is an AP-rated substitutable generic version of Teva's Copaxone® 40 mg/mL, as well as Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone® 20 mg/mL. These products are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Shipments to customers have commenced.
NATCO’s marketing partner Mylan receives final approval of generic Glatiramer Acetate, for both 20 mg/mL and 40 mg/mL versions 04 October 2017
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved its marketing partner Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone® 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone® 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. The launch plans for both products will be communicated shortly after concurring with its partner Mylan.
Copaxone® is the most prescribed MS treatment for relapsing forms of MS in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending July 31, 2017, according to Quintiles IMS. Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.
Natco & its alliance partner Lupin receive FDA approval for generic Lanthanum Carbonate Chewable Tablets 14 August 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base). The product, as the first generic, will be launched shortly in the USA market.
Natco’s Lanthanum Carbonate strengths mentioned above are generic equivalents of Shire Development LLC’s Fosrenol® Chewable Tablets and are indicated to reduce serum phosphate in patients with End Stage Renal Disease (ESRD).
Fosrenol® Chewable Tablets has US sales of USD 122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol® Chewable Tablets.
NATCO records INR 448.7 crore consolidated revenue and profit after tax of INR 93.7 crore, for the First Quarter, FY 2017-18 07 August 2017
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated revenues of INR 448.7 Crore for the quarter ended on 30th June, 2017, as against INR 345.5 Crore during the same quarter last year, reflecting an increase of about 30% Year on Year (YoY).
The net profit for the period, after tax, on a consolidated basis, was INR 93.7 Crore, as against INR 47.5 Crore same quarter last year, showing a growth of 97% Year on Year (YoY).
Edelweiss Securities invites you to the Q1 FY18 Earnings call of Natco Pharma Limited. 02 August 2017
Mr. Rajeev Nannapaneni, CEO & Mr. Rajesh Chebiyam, VP, Business Development and Corporate Support will be addressing investor queries in Natco Pharma Limited’s Q1 FY2018 Earnings Conference Call hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting – August 7th, 2017 29 July 2017
A meeting of the Board of Directors of the Company is scheduled to be held on Monday, the 7th day of August 2017 at 10.30 a.m. at the Registered Office of the Company to consider, among other things, the following items of businesses and related matters:
1. Unaudited financial results for the quarter ended 30th June, 2017 along with the Limited Review Report thereon.
2. To Consider Interim Dividend, if any, for the year 2017-18.
3. Convening of 34th Annual General Meeting to be held for the financial year 2016-17.
4. Consideration of Natco Employee Stock Option Scheme 2017 (NATSOP 2017) under SEBI (Share Based Employee Benefits) Regulations, 2014.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 31st July 2017 to 9th August 2017 (both days inclusive). Trading window will be opened from 10th August 2017.
Natco Receives Establishment Inspection Report (EIR) from U.S. Food And Drug Administration (FDA) 20 July 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the receipt of successful Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility at Kothur Unit, Telangana, India, during the period Jan 16th – 24th, 2017. This Kothur formulation facility predominantly caters to regulated international markets, including USA.
NATCO receives final approval for Generic AZACITIDINE for Injection (VIDAZA®) for USA market 27 June 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Azacitidine for Injection, 100mg per Vial, Single-Dose Vial, a generic version of Vidaza® by Celgene Corporation. NATCO and its marketing partner Breckenridge Pharmaceutical, Inc. (BPI) plan to launch this product in the USA market in the near future.
Vidaza® is a prescription anti-cancer chemotherapy drug that is indicated to treat myelodysplastic syndrome (MDS). Vidaza® generated total combined sales of $188 million for the twelve-month period ending April, 2017, based on industry sales data.
NATCO records INR 2078.9 Crore total consolidated revenue and INR 486.0 Crore of profit, after tax, for the full year ended March 2017 30 May 2017
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 2078.9 Crore for the year ended on
31st March, 2017, as against INR 1089.7 Crore for the last year, reflecting a year-over-year growth of 90.8%. The net profit for the period, on a consolidated basis, was INR 486.0 Crore, as against INR 157.1 Crore last year, showing a growth of 209.3%.
For the fourth quarter (Q4) ended March 31st, 2017, the company recorded a net revenue of INR 577.2 Crore, on a consolidated basis, as against INR 394.8 Crore during Q4, FY 2016, posting an increase of 46.2%. The profit after tax, on a consolidated basis, was recorded as INR 176.7 Crore for the quarter, as against INR 62.8 Crore same quarter last year, showing a growth of 181.4%.
The revenue and profit growth for the company during the financial year was driven primarily due to the sales of generic Oseltamivir product in the USA market and continued growth of domestic formulations business.
All results for the quarter and previous year FY2016 have been restated to comply with Indian Accounting Standards (Ind AS) to make them comparable.
Edelweiss Securities invites you to the Q4 FY17 Earnings call of Natco Pharma Limited. 26 May 2017
Mr. Rajeev Nannapaneni, CEO & Mr. Rajesh Chebiyam, VP, Business Development and Corporate Support will be addressing investor queries in Natco Pharma Limited’s Q4 FY2017 Earnings Conference Call hosted by Edelweiss Securities.
Click here for more details.
Notice of Board Meeting - 30th May, 2017 20 May 2017
A meeting of the Board of Directors of the Company is scheduled to be held on Tuesday, the 30th day of May, 2017 at 11.00 a.m. at Registered Office of the Company, inter alia, to consider and approve the Audited Financial Results for the quarter and year ended 31st March, 2017 and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 20th May, 2017 to 01st June, 2017 (both days inclusive). Trading window will be opened from 02nd June, 2017.
NATCO’s partner Dr. Reddy's Laboratories announces USFDA approval for the launch of Doxorubicin Hydrochloride Liposome Injection in the U.S. Market 17 May 2017
Natco Pharma Limited is pleased to announce that its partner Dr. Reddy’s Laboratories Ltd. has received approval from the U.S. Food and Drug Administration (USFDA) to launch Doxorubicin Hydrochloride Liposome Injection, a therapeutic equivalent generic version of Doxil®(doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.
Please find enclosed herewith the Press Release of our partner Dr. Reddy’s Laboratories Ltd. in this connection for more details.
NATCO launches POMALID, first generic version of pomalidomide capsules, for treatment of a specific blood cancer, in INDIA 10 May 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of pomalidomide 1 mg, 2 mg, and 4 mg capsules in India. Pomalidomide is sold by Celgene Inc., in the USA, under the brand name POMALYST®.
Pomalidomide is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma (a type of blood cancer) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Natco will market generic pomalidomide capsules under its brand name POMALID in India. Natco priced its generic medicine of POMALID 1 mg, 2 mg, and 4 mg capsules at an MRP of INR 5000/-, INR 10,000/-, and INR 20,000/- respectively for a monthly pack of 21 capsules. We believe, this is approximately 98% discount of price from what it is sold at in the USA to patients, per secondary market data researched.
NATCO launches VELPANAT, generic version of Sofosbuvir 400 mg/ Velpatasvir 100 mg fixed dose combination tablets in INDIA 08 May 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched a generic version of Sofosbuvir 400 mg / Velpatasvir 100 mg fixed dose combination in India. Sofosbuvir 400 mg / Velpatasvir 100 mg fixed dose combination is sold by Gilead Sciences, Inc., globally, under the brand name Epclusa®.
Epclusa® is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic Hepatitis C virus (HCV) infection. Epclusa is a prescription medicine used to treat adults with chronic (lasting a long time) Hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated).
Natco will market Sofosbuvir 400 mg / Velpatasvir 100 mg under the brand name VELPANAT. Natco priced its generic medicine of VELPANAT at an MRP of INR 18,500/- for a bottle of 28 tablets in India. Natco has signed a nonexclusive licensing agreement with Gilead Sciences, Inc., to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.
NATCO records INR 685.13 Crore total consolidated revenue and INR 194.76 Crore of profit, after tax, for the Third Quarter, FY 2017 14 February 2017
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total revenue of INR 685.13 Crore for the quarter ended on 31st December, 2016, as against INR 293.45 Crore during the same quarter last year, reflecting an increase of about 134%.
The net profit for the period, on a consolidated basis, was INR 194.76 Crore, as against INR 37.04 Crore same quarter last year, showing a growth of 425%. The revenue and profit growth for the company during the quarter was driven predominantly by the sales of Oseltamivir product in the USA market and includes profit sharing from our marketing partner.
Edelweiss Securities invites you to the Q3 FY17 Earnings call of Natco Pharma Limited. 09 February 2017
Notice of Board Meeting – February 14th, 2017 08 February 2017
A meeting of the Board of Directors of the Company is scheduled to be held on Tuesday, the 14th day of February, 2017 at 11.00 a.m. at Registered Office of the Company to consider among other things, the following items of business:
1. The unaudited financial Results for the quarter ended 31st December, 2016 and related matters.
2. To consider second Interim Dividend, if any, for the financial year 2016-17 and related matters etc.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 3rd February, 2017 to 16th February, 2017 (both days inclusive). Trading window will be opened from 17th February, 2017.
NATCO’s partner Mylan Wins U.S. District Court Ruling Related to Copaxone® 40 mg/mL Patents 31 January 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that the United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone® 40 mg/mL invalid based on obviousness.
The invalidated patents are United States Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries, Ltd.
On Dec. 2, 2016, the U.S. Patent and Trademark Office's U.S. Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision that three of these patents ('250, '413 and '302) are unpatentable in its inter partes review (IPR) proceedings initiated by NATCO’s marketing partner Mylan. Mylan also challenged the '776 patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on the '776 patent IPR by May 16, 2017.
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending Nov. 30, 2016, according to IMS Health.
NATCO updates on USFDA inspection at its Kothur Formulation Facility 25 January 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) updated that an inspection was conducted by the United States Food & Drug Administration (USFDA) at its Pharmaceutical Formulations facility in Kothur, near Hyderabad, between January 16-24, 2017.
At the end of the inspection, the facility received six observations, all of which are correctable and procedural, and which the company believes are minor in nature. The observations are related to complaint and incident investigations, stability backlog and procedural SOP’s. A copy of the observations is attached.
The company will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.
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NATCO receives final approval for Generic Bendamustine HCl Powder for USA Market 06 January 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce the final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial). Pursuant to the settlement of the Paragraph IV litigation, NATCO plans to launch this drug on November 1, 2019, or earlier under certain circumstances, through its marketing partner Breckenridge Pharmaceutical, Inc., in the USA market. Natco and Breckenridge filed their ANDA with a Paragraph IV certification on the first-to-file date and expect to share 180-day exclusivity with other ANDA first filers.
Cephalon (acquired by Teva in 2011) sells Bendamustine Hydrochloride powder for Injection, 25 mg/Vial and 100 mg/Vial (Singe-Dose Vial) under Brand name TREANDA® in the USA market. TREANDA® is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma. TREANDA® had U.S. sales of approximately $133 Million for twelve months ending November, 2016, according to IMS Health.
NATCO launches VELPANAT in Nepal - 1st generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination medicine in the country 02 January 2017
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination in Nepal. Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination is sold by Gilead Sciences, Inc., under brand name Epclusa®.
Epclusa® is the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for Ribavirin.
Natco will market Sofosbuvir 400mg/Velpatasvir 100mg under the brand name VELPANAT®. Natco priced its generic medicine of VELPANAT at an MRP of INR 25,000/- equivalent for a bottle of 28 tablets in Nepal. Natco has signed a non-exclusive licensing agreement with Gilead Sciences, Inc., to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries.
NATCO launches the first generic version of Oseltamivir Capsules in the USA market 12 December 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce launch of the first generic version of Oseltamivir oral capsules, 30 mg, 45 mg and 75 mg through its marketing partner Alvogen in the USA market, as of December 12th, 2016.
NATCO receives final approval for Generic Armodafinil tablets for USA market 29 November 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic version of Armodafinil Tablets, 50 mg, 150 mg, and 250 mg . NATCO and its marketing partner Breckenridge Pharmaceutical, Inc., plan to launch this product in the USA market immediately.
Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under Brand name NUVUGIL® in the USA market. NUVUGIL® is a wakefulness promoting agent for oral administration. NUVUGIL® Tablets had U.S. sales of approximately $480 Million for twelve months ending December 2015, according to IMS Health.
NATCO receives final approval for generic Budesonide Capsules, 3 mg, for USA market 24 November 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for generic version of Budesonide Capsules (Enteric Coated), 3 mg . NATCO and its marketing partner Alvogen plan to launch this product in the USA market immediately.
Perrigo Pharma International DAC sells Budesonide Capsules under their brand ENTOCORT® in the USA market. ENTOCORT® EC Capsules, 3 mg, and its generic versions had U.S. sales of approximately $370 Million for twelve months ending December 2015, according to IMS Health.
NATCO records INR 467.86 Crore operating revenue for the Second Quarter, FY 2017, ended September 2016 11 November 2016
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated total income from operations of INR 467.86 Crore for the quarter ended on 30th September, 2016, as against INR 243.02 Crore during the same quarter last year, reflecting an increase of about 92.5%.
The net profit for the period, on a consolidated basis, was INR 65.97 Crore, as against INR 30.28 Crore same quarter last year, showing a growth of 117.9 %. The growth for the company during the quarter was driven primarily by increased sales of its formulation business.
IDFC Securities invites you to the Q2 FY17 Earnings call of NATCO Pharma Limited 08 November 2016
Notice of Board Meeting – November 11th, 2016 01 November 2016
A meeting of the Board of Directors of the Company is scheduled to be held on Friday, the 11th November, 2016 at 11.00 a.m. at the Registered Office of the Company to consider among other things, the Unaudited Financial Results for the quarter and half year ended 30th September, 2016 and related matters.
Please further note that pursuant to the SEBI (Prohibition of Insider Trading) Regulations, 2015 TRADING WINDOW for dealing in the securities of the Company will be closed from 1st November, 2016 to 13th November, 2016 (both days inclusive). Trading window will be opened from 14th November, 2016.
NATCO’s marketing partner Mylan Invalidates Third Teva Copaxone®... 02 September 2016
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd., unpatentable. This is the third patent related to Copaxone® 40 mg/mL to be found unpatentable in the last week.
On August, 24, 2016 the PTO's Patent Trial and Appeal Board (PTAB) found Teva's first two patents, U.S. Patent Nos. are 8,232,250 and 8,399,413, unpatentable in Mylan's IPR challenge of these patents.
NATCO’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
Copaxone® 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.
NATCO’s marketing partner Mylan Invalidates Two of Teva's Copaxone®... 25 August 2016
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that the U.S. Patent and Trademark Office (PTO) has ruled in favour of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of two related Copaxone® 40 mg/mL patents to be unpatentable. The U.S. Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's third petition seeking inter partes review of U.S. Patent No. 8,969,302 is expected on or before September 1, 2016.
On Aug. 15, the PTO's Patent Trial and Appeal Board (PTAB) found Mylan's application against a fourth Copaxone 40 mg/mL patent, U.S. Patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan believes that today's favourable ruling in the IPR against the '250 and '413 patents strongly undermines the '776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the '776 patent.
NATCO’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application containing a Paragraph IV certification for a three times per week Glatiramer Acetate Injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.
NATCO receives Establishment Inspection Report for Chennai facility 25 August 2016
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted, during the period February 8 – February 12, 2016, at its Chemical Division, Chennai, India (named NATCO Organics Limited, prior to amalgamation into the company).
NATCO receives Establishment Inspection Report for Kothur facility 16 August 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce receipt of successful Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug manufacturing facility in Kothur Village, Mahaboob Nagar District, India, during the period February 29 – March 7, 2016. The Kothur facility predominantly caters to regulated international markets, including USA.
NATCO records INR 325.22 crore operating revenue for the First Quarter, ended June 2016 09 August 2016
Hyderabad based NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has recorded consolidated net operating revenues of INR 325.22 Crore for the quarter ended on 30th June, 2016, as against INR 223.71 Crore during the same quarter last year, reflecting an increase of about 45.4%.
The net profit for the period, after tax and minority interest, on a consolidated basis, was INR 47.65 Crore, as against INR 28.07 Crore same quarter last year, showing a growth of 69.8%. The growth for the company was predominantly driven by increased sales of its oncology and hepatitis C products in India.
Natco Receives Final Approval For Generic Oseltamivir 04 August 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic versions of Oseltamivir oral capsules, 30 mg, 45 mg and 75 mg. NATCO and its marketing partner Alvogen are the first generic players to receive this approval.
Earlier in December, 2015, NATCO and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. Under the terms of the settlement, NATCO’s partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA’s Orange Book for U.S. Patent No. 5,763,483, which is February 23, 2017.
Edelweiss Securities invites you to the Q1 FY17 Earnings call of NATCO Pharma Limited 02 August 2016
Notice of Board Meeting – August 9th, 2016 01 August 2016
A meeting of the Board of Directors of the Company is scheduled to be held on Tuesday, 9th August, 2016 at 11.00 a.m. at the Registered Office of the Company to consider among other things, the following items of businesses and related matters:
1. Unaudited financial Results for the quarter ended 30th June, 2016.
2. To Consider Interim Dividend, if any, for the year 2016-17.
3. Convening of 33rd Annual General Meeting for the financial year 2015-16.
4. Consideration of Employee Stock Option Scheme (NATSOP2016) under SEBI (Share Based Employee Benefits) Regulations, 2014.
Please further note that TRADING WINDOW for dealing in the securities of the Company will be closed from 1st August, 2016 to 11th August, 2016 (both days inclusive). Trading window will be opened from 12th August, 2016.
Winner of ‘Golden Peacock Environment Management Award’ for the Year 2016 09 July 2016
Natco Pharma Limited’s Chemical Division at Mekaguda was declared as the Winner of ‘Golden Peacock Environment Management Award’ for the year 2016.
The award was presented at the Institute of Directors (IOD) India's “18th World Congress on Environment Management” held on 8, 9th July 2016 at The Ashok Hotel, New Delhi. The theme of the event was “Environment and Climate Change - Transitioning to a Sustainable Economy” and it was attended by a distinguished gathering of diplomats and business leaders.
Mr. PSRK Prasad, Executive Vice President Corp Engineering Services and Mr. Srinivas Rao, Deputy General Manager, Environment Health and Safety, attended the event and received the award on behalf of the Company from Justice (Dr.) Arijit Pasayat, Co-Chairman, Institute Of Directors & former Judge, Supreme Court of India.
NATCO receives USFDA tentative approval for Sorafenib Tablets, 200mg 03 June 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that its marketing partner, Mylan Inc. (Nasdaq:MYL), has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. Food and Drug Administration (USFDA). This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
NATCO and Mylan have filed an ANDA containing a Paragraph IV certification for this product. NATCO manufactures this product at its facility in Kothur, Mahaboobnagar District, Telangana State, India.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the U.S. market. For the 12 months ending Dec. 31, 2015, NEXAVAR® had U.S. sales of approximately $300 million.(SOURCE: Bayer’s Annual Report)
NATCO records Rs.1152.38 crores net revenues & Rs.155.19 crores net profit after tax, for the year ended March 2016 26 May 2016
The Board of NATCO Pharma Limited (NPL) met in Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2016.
NPL recorded an aggregate of Rs.1152.38 crores in consolidated net revenues for the year ended on 31st March, 2016, as against Rs.840.18 crores for last year, with a year-over-year growth of 37.15% in the topline. The net profit, after tax, on a consolidated basis, was recorded as Rs.155.19 crores for the year ended 31st March, 2016, as against Rs.134.61 for the previous year.
For the fourth quarter (Q4) ended March 31st, 2016, the Company recorded a net revenue of Rs.408.47 crores, on a consolidated basis, as against Rs.204 crores during Q4, FY 2015, posting an increase of about 100%. The profit after tax, on a consolidated basis, was recorded as Rs.60.24 crores for the quarter. The key driver for the accelerated revenue growth was the company’s Hepatitis C portfolio of products in the domestic Indian market.
Edelweiss Securities invites you to the Q4 FY16 Earnings call of NATCO Pharma Limited 23 May 2016
Notice of Board Meeting – May 26th, 2016 11 May 2016
A meeting of the Board of Directors of the Company is scheduled to be held on Thursday, May 26th 2016 at 11.00 am at Registered Office of the Company to consider and approve the Audited Financial Results for the Year ended 31st March, 2016.
Please note that the trading window for dealing in the securities of the Company will be closed for Promoters, Directors, Connected Persons, Insiders, Employees and their immediate relatives from 16th May, 2016 to 28th May, 2016 (both days inclusive). It will be opened from 30th May, 2016.
High Court approves amalgamation scheme of NATCO 09 May 2016
The High Court of Madras vide its Order dated 28th April, 2016, has sanctioned the Scheme of Amalgamation of NATCO Organics Limited, a Wholly Owned Subsidiary of the Company with NATCO Pharma Limited.
NATCO updates on Sale of US Store 07 April 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) completed the transaction of sale of its SAVE MART PHARMACY Store located in USA to CARE MART Inc., for which an agreement was executed. The agreement inter-alia provides for consideration towards goodwill, furniture and fixtures, Inventory etc.
Natco Board approves sale of its Save Mart Store in the USA 30 March 2016
The Board of Directors of Natco Pharma Limited at their meeting held on the 30th of March 2016, approved the sale of its Save Mart Pharmacy Store located in the USA. The Save Mart Pharmacy Store is owned by Natco Pharma Inc., a wholly owned subsidiary of the Company, and is considered as a non-core part of the business.
Natco updates on USFDA Inspection 27 March 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) updated that an inspection was conducted by the United States Food & Drug Administration (USFDA) in two of its manufacturing facilities recently- the Active Pharmaceutical Ingredients (API) manufacturing facility at Manali, near Chennai, and the Pharmaceutical Formulations facility at Kothur, near Hyderabad, during early February and March, 2016, respectively.
The company received Form-483 observations for both facilities and believes them to be of minor in nature. The company has already sent response and compliance report for these observations and believes that there would be no adverse impact to its current or future pipeline products coming from these facilities.
NATCO records Rs.281.40 crores revenue for the Third Quarter, ended December 2015 11 February 2016
Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.281.40 Crores in consolidated net revenues for the quarter ended on 31st December, 2015, as against Rs.202.80 Crores during the same quarter last year, recording an increase of about 38.75%.
The net profit, after tax, on a consolidated basis, was Rs.37.15 Crores, as against Rs.14.34 Crores same quarter last year that had a one-time exceptional expense. The solid growth in revenue & profit for the quarter was largely driven by domestic formulation business, the revenues for which grew to about Rs.170 crores during Q3 FY16, as opposed to about Rs.62 crores same quarter previous year, reflecting a 175% growth.
Nirmal Bang invites you to the Q3 FY16 Earnings call of NATCO Pharma Limited 08 February 2016
Notice of Board Meeting – February 11th, 2016 30 January 2016
This is to inform you that the meeting of the Board of Directors of the Company is scheduled to be held on Thursday, the 11th day of February, 2016 at 11.00 a.m. at Registered Office of the Company to consider among other things, the following:
1. The unaudited financial Results for the quarter and nine months ended 31st December, 2015 and related matters
2. To consider Interim Dividend, if any, for the financial year 2015-16 and related matters etc.
Please further note that TRADING WINDOW for dealing in the securities of the Company will be closed for romoters, Directors, Connected Persons, Insiders, Employees and their immediate relatives from 3rd February, 2016 to 13th ebruary, 2016 (both days inclusive). It will be opened from 15th February, 2016.
NATCO Announces Licensing Agreement for Daclatasvir 21 January 2016
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a nonexclusive, royalty free licensing agreement with the Medicines Patent Pool (MPP) and Bristol-Myers
Squibb to manufacture and sell generic versions of Bristol-Myers Squibb’s chronic hepatitis C
medicine – Daclatasvir Dihydrochloride (Daclatasvir).
Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV)
genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV
patient subsets.
Natco will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India.
This agreement allows Natco to expand access to these chronic hepatitis C medicines in 112 developing countries. Under the license, Natco can set its own price for the generic products it produces.
NATCO announces REVLIMID® Settlement with Celgene 23 December 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and its US partner Allergan announce settlement of its pending litigation with Celgene regarding generic Lenalidomide.
Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic Lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total Lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total Lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license under this agreement.
REVLIMID® had recorded sales of nearly $3.4 billion in the US market for the year ending September 2015 (Source: Celgene Website).
NATCO receives generic Ledipasvir + Sofosbuvir approval for India 15 December 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General (India). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India.
Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies.
NATCO will price its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets. NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in 100 other developing countries in addition to India.
NATCO RECEIVES GENERIC DACLATASVIR APPROVAL FOR INDIA 14 December 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is the 1st company in India to get approval for generic Daclatasvir Dihydrochloride (“Daclatasvir”) tablets, 30mg & 60mg, from Drugs Controller General (India). Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets.
Natco will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India. Natco will launch Immediately in India at an MRP of Rs.6000/-(Rupees Six thousand only) and Rs.4000/- (Rupees Four Thousand only) for the 60mg and 30mg strengths, respectively, for a bottle of 28 tablets.
Alvogen And Natco Settle Infringement Suit With Gilead And Others For Generic Oseltamivir 14 December 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) and Alvogen, who have partnered on the first Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the U.S. Food and Drug Administration (FDA) for generic versions of Oseltamivir phosphate oral capsules, 30 mg, 45 mg and 75 mg, announced today that they have settled the patent infringement suit filed by Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. against Alvogen and Natco in New Jersey District Court (2:11-cv-04969-SDW–MCA).
FDA granted tentative approval to NATCO for the generic oseltamivir phosphate capsules on March 14, 2014. Under the terms of the settlement, NATCO’s partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA’s Orange Book for U.S. Patent No. 5,763,483, which is February 23, 2017.
Natco Pharma’s WOS API plant operations at Chennai temporarily suspended due to flooding 02 December 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) stated today that its Wholly Owned Subsidiary’s (WOS’s) Active Pharmaceuticals Ingredient (API) Plant at Manali Industrial Area, Chennai, has temporarily suspended operations due to flooding caused by incessant rains in the plant area.
The Unit manufactures a few oncology related APIs at its Manali site. The company believes that this temporary shutdown should not impact/impair its pipeline launches associated with this plant. The Unit is also adequately insured for any losses it has incurred in fixed assets, raw materials and loss in production including work-in-progress. Actual losses will be assessed once this natural calamity passes by, and the plant is back in full operational mode.
Key Managerial Personnel updation 02 December 2015
Pursuant to Regulatin30 (5) of SEBI (Listing and Obligation Disclosure Requirements) Regulations, 2015, please find below the details of the Key Managerial Personnel who have been jointly severally authorised by the Board of Directors of the Company:
To determine the materiality of an even or information under this regulation and also making disclosures to stock Exchange (s):
| Name |
Designation |
E-mail Id |
| Mr. V C Nannapaneni |
Chairman & Managing Director |
chairman@natcopharma.co.in |
| Mr. Rajeev Nannapaneni |
Vice Chairman & CEO |
rajeev@natcopharma.co.in |
| Mr. M. Adinarayana |
Company Secretary & Vice President (Legal & Corp Affairs) |
man@natcopharma.co.in |
| Mr. S.V.V.N. Appa Rao |
Interim Chief Financial Officer |
svvn@natcopharma.co.in |
| Contact Address: |
NATCO Pharma LimitedNATCO House, Road No.2, Banjara HillsHyderabad 500 034, Telangana |
| Contact No. |
040-23547532 |
Religare invites you to the Q2 FY16 Earnings call of NATCO Pharma Limited 16 November 2015
NATCO records Rs.236.97 crores revenue for the Second Quarter, ended September 2015 13 November 2015
Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.236.97 Crores in consolidated net revenues for the quarter ended on 30th September, 2015, as against Rs.222.42 Crores during the same quarter last year, recording an increase of about 6.6%.
The net profit, after tax, on a consolidated basis, was Rs.29.57 Crores, as against Rs.32.37 Crores same quarter last year. This is a decrease of about 8.6% compared to same quarter last year. The growth in profit for the quarter was constrained due to delay in exports to South America. However, sales of domestic formulation segments, including Sofosbuvir, continue to do well. The company expects stronger sales growth with higher profitability, during H2 of FY2016.
NATCO launches HEPCINAT LP in Nepal 28 October 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first licensed generic version of ledipasvir+sofosbuvir combination in Nepal, under its brand name Hepcinat LP.
Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, Inc., under its brand HARVONI®. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. NATCO priced its generic medicine, Hepcinat LP, at an MRP of INR 25,000/- for a bottle of 28 tablets in Nepal.
Natco had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI®, in India and other 100 developing countries.
NATCO received the “Best Speciality Brand-SILVER AWARD” for marketing excellence in India, during 2014-15 fiscal year 15 October 2015
NATCO received the “Best Speciality Brand-SILVER AWARD” for marketing excellence in India, during 2014-15 fiscal year, for one of its flagship oncology brands – ERLONAT, by AWACS.
The award was presented by All Indian Origin Chemists & Distributors (AIOCD) AWACS. AWACS is a market research agency with syndicated audit Pharma Trac. These awards are instituted to recognise and reward top performers of the domestic pharma industry. This was the first edition of such awards, by an independent market research agency in India.
ERLONAT was introduced by NATCO as the first generic Erlotinib in the year 2009. It was marketed at a fractional cost of the innovator drug, which benefitted thousands of non-small cell lung cancer and pancreatic cancer patients.
On behalf of the NATCO team, Mr.K. Srivastava-Vice President (Sales and Marketing), Mr. James Rajakumar- GM (Oncology Division) & Mr. Lalon Sen-Product Manager (Lung Cancer Portfolio) received the award on 7th October 2015 at Nehru Centre, Worli, Mumbai.
NATCO PHARMA LIMITED, WINNER OF ‘ GOLDEN PEACOCK INNOVATION MANAGEMENT AWARD’ FOR THE YEAR 2015 12 October 2015
Natco Pharma Limited was declared as the Winner of ‘Golden Peacock Innovation Management Award’ for the year 2015, by the Awards Jury of Golden Peacock Awards Chaired by Justice M.N.Venkatachaliah, former Chief Justice, Supreme Court of India.
The award was presented at a specially organized event by the Institute of Directors (IOD), India, “Global Peacock Awards Nite” held on 8thOctober 2015 at Millennium Hotel, London Mayfair. This occasion was graced by distinguished gathering of business leaders attending the IOD India’s 15th London Global Convention wherein conference on “Corporate Governance & Sustainability" and “Global Business Meet” were held during 7 - 9 October, 2015 in London (UK).
Dr.A.K.S. Bhujanga Rao, Director and President (R&D and Tech.) and CS M. Adinarayana, Company Secretary & Vice President (Legal & Corp. Affairs) attended the event and received the award on behalf of the Company from the hands of the Rt. Hon Oliver Letwin MP, The Chancellor of the Duchy of Lancaster and Hon'ble Cabinet Minister of United Kingdom.
Natco Closes QIP 15 September 2015
Natco Announces QIP Issue 10 September 2015
NATCO receives FIPB approval for Qualified Institutional Placement for up to Rs.450 crores and Foreign Investment limit increase to 31.5% 13 August 2015
Hyderabad based NATCO Pharma Limited informed that Foreign Investment Promotion Board (FIPB) has approved both of its Foreign Direct Investment (FDI) related proposals in its 221
st Meeting held on July 13
th, 2015.
The two approvals given are for:-
- Increase of Foreign Investment Limit from 24% to 31.5% of the paid up equity share capital of the company.
- Issue and Allotment of Eligible Securities to Qualified Institutional Buyers (QIBs) up to Rs.450 crores.
NATCO Stock Split - Records Rs.225.54 crores revenue for the First Quarter, ended June 2015 12 August 2015
Board of Directors of Hyderabad based NATCO Pharma Limited approved and recommended to the members of the company a Sub-division of face value of its equity shares from Rs.10/-(rupees ten only) each to that of Rs.2/-(rupees two only) each. It also announced an aggregate consolidated net revenues of Rs.225.54 Crores for the quarter ended on 30th June, 2015, as against Rs.211.48 Crores during the same quarter last year thus recording an increase of about 6.6%.
The net profit, after tax, on a consolidated basis, was Rs.28.23 Crores, as against Rs.33.46 Crores for the same quarter last year. Although this is a decrease of about 15.6% compared to the same quarter last year, the company expects strong sales growth with high-margin products, in the ensuing quarters of FY2016.
IDFC Securities invites you to the Q1 FY16 Earnings call of NATCO Pharma Limited 08 August 2015
U.S.Court of Appeals for the Federal Circuit Finds Teva’s 808 COPAXONE Patent Invalid 19 June 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that U.S Court of Appeals for Federal Circuit has again found Teva’s US Patent No.5.800.808 (“the 808 patent”) for Copaxone to be invalid as indefinite. The Company awaits USFDA approval to launch the Product.
EGM notice for the members of Natco Pharma Limited will be held on Saturday, the 27th June, 2015. Click for more info 04 June 2015
Notice is hereby given that an Extraordinary General Meeting of the Members of Natco Pharma Limited will be held at at Jubilee Hills International Centre, Road No.14, Jubilee Hills, Hyderabad 500033 on Saturday, the 27th June, 2015 at 10.30 a.m.
Click her for a PDF with more information
NATCO records Rs.840 crores net revenues for the year ended March 2015 25 May 2015
The Board of Natco Pharma Limited (NPL) met in Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2015.
NPL recorded an aggregate of Rs.840.18 crores in consolidated net revenues for the year ended on 31st March, 2015, as against Rs.755.60 crores for last year, reflecting a growth of 11.20%.
The net profit, after tax, on a consolidated basis, was recorded as Rs.134.61 crores. This includes two exceptional items:
(a) A decrease in profit on account of an extraordinary charge of Rs.15.13 crores due to a legal settlement.
(b) An increase in profit on account of a reversal of deferred tax liability of Rs.31.17 crores for the quarter ended March 31st, 2015, the Company recorded a net revenue of Rs.204 crores, on a consolidated basis, as against Rs.193.76 crores during Q4, FY 2014, posting an increase of 5.28%, quarter-on-quarter basis. The profits, after tax, on a consolidated basis, was recorded as Rs.54.44 crores, which includes a deferred tax reversal.
NATCO RECEIVES GENERIC SOFOSBUVIR (SOVALDI®) APPROVAL FOR INDIA 11 March 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it is the 1st company in India to get approval for generic sofosbuvir tablets, 400mg, from Drugs Controller General (India). Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc.,under its brand Sovaldi®.
Natco will market generic sofosbuvir under its brand HEPCINAT and through strategic partners in India. Natco plans to price its generic medicine at an MRP of INR 19,900 for a bottle of 28 tablets and expects to launch in India very soon. Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.
NATCO launches HEPCINAT in Nepal- 1 st generic version of Sofosbuvir (Sovaldi®) in the country 09 March 2015
NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has launched the first generic version of sofosbuvir in Nepal. Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi®. Natco priced its generic medicine at an MRP of INR 19,900 for a bottle of 28 tablets in Nepal.
NATCO markets generic sofosbuvir under its brand HEPCINAT. Natco hopes to launch HEPCINAT in India soon, subject to approval from the Drugs Controller General of India (DCGI). Natco had recently signed a non-exclusive licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic hepatitis C medicines in 91 developing countries.
Supreme Court Agrees With NATCO and denies Petition For Certiorari On Generic Oseltamivir Patent 09 March 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is pleased with the U.S.Supreme Court’s decision to deny certiorari for the generic version of Oseltamivir phosphate oral capsules. Natco is partnered with Alvogen in the USA for marketing of this product. The denial was issued on March 9, 2015, in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, No. 14-647.
Natco has already received a tentative approval on March 14, 2014, for Oseltamivir Phosphate Capsules USP,30 mg (base), 45 mg (base) and 75 mg (base) on the Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the United States Food & Drug Administration (USFDA).
In the April 22, 2014 Federal Circuit decision, Circuit Judges Chen and Prost agreed with Natco and Alvogen’s position that an earlier filed and earlier expiring patent qualifies as an obviousness-type double patenting reference for a later filed, and later expiring patent. The Supreme Court today declined to review the Federal Circuit’s decision. The case remains pending in the District of New Jersey where the validity of U.S. Patent No. 5,763,483 continues to be challenged.
NATCO announces Licensing Agreement with Gilead Sciences 02 March 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has signed a nonexclusive
licensing agreement with Gilead Sciences, to manufacture and sell generic versions of its chronic
hepatitis C medicines. The medicines include sofosbuvir, ledipasvir/sofosbuvir and the investigational NS5A
inhibitor GS-5816, which is being evaluated in Phase 3 clinical studies as part of a single tablet regimen that
combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C.
This agreement allows Natco to expand access to these chronic hepatitis C medicines in 91 developing
countries. Under the license, Natco can set its own price for the generic products it produces, paying a
royalty on sales to Gilead to support product registrations, medical education and training, safety
monitoring and other essential business activities.
NATCO announces USFDA Filing for Sorafenib Tablets, 200mg 11 February 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that its marketing partner, Mylan Inc. (Nasdaq:MYL), has filed an Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the U.S. Federal Drug Administration (USFDA). This product is the generic version of NEXAVAR®, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.
Natco and its marketing partner believe that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.
Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR®, in the USA market. For the 12 months ending Dec. 31, 2014, NEXAVAR® had U.S. sales of approximately $48 million, according to IMS Health.
@The trademark is the property of the respective Owner.
NATCO records Rs.202.80 crores revenue for the Third Quarter, ended December 2014 11 February 2015
Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.202.80 Crores in consolidated net revenues for the quarter ended on 31st December, 2014, as against Rs.204.63 Crores during the same quarter last year, recording a slight decrease of about 1%. The net profit, after tax, on a consolidated basis, before exceptional item was Rs.29.47 Crores, as against Rs.29.88 Crores same quarter last year.
There was a one-time exceptional charge of Rs.15.13 crores for settlement of a legal case during Q3. As a result, the net profit, after tax, on a consolidated basis, was Rs.14.34 Crores.
NATCO announces USFDA Filings for Fingolimod, 0.5mg Capsules and Cabazitaxel 60mg/1.5ml Injection 09 February 2015
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the U.S. Federal Drug Administration (USFDA), through its respective marketing partners in the USA.
Natco & its associated marketing partners for the above products in the USA, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, providing 180 days of marketing exclusivity upon its final USFDA approval.
Novartis sells Fingolimod 0.5mg Capsules under Brand name Gilenya®, in the USA market and used for the treatment of certain patients with multiple sclerosis. The market size of Gilenya® in the USA is approximately US$1.2 Billion for twelve months ending September 2014, according to IMS Health.
Sanofi sells Cabazitaxel 60mg/1.5ml Injection under Brand name Jevtana®, in the USA market and used for the treatment of certain patients with hormone-refractory prostate cancer. The market size of Jevtana® in the USA is approximately US$116.8 Million for twelve months ending September 2014,according to IMS Health.
All trademarks are the property of their respective owners.
SLP filed by Bayer against Natco has been dismissed by Hon'ble Supreme Court of India 12 December 2014
Natco Pharma Ltd. wishes to announce that the Special Leave Petition (SLP) preferred by Bayer Corporation against the order of Bombay High Court dt.15th July, 2014 confirming the Compulsory License (CL) grant to Natco Pharma Ltd. has been dismissed today by the Hon’ble Supreme Court of India. The said SLP was filed by Bayer against Union of India, Natco Pharma Ltd. and Others for the grant of CL to Natco for Bayer’s product Sorafenib (which is used for liver and kidney cancer).
NATCO records Rs.32.37 crores profit for the Second Quarter, ended September 2014 12 November 2014
Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.222.42 Crores in consolidated net revenues for the quater ended on 30th September, 2014, as against Rs.181.20 Crores during the same quater last yeat, recording an increase of about 23%. The net profit, after tax, on a consolidated basis, improved to Rs.32.37 Crores, as against Rs.26.92 Crores same quater reflecting a 20% increase.
Intimation 22 October 2014
NATCO announces USFDA Tentative Approval for Armodafinil 50mg, 150mg, and 250mg Tablets 21 October 2014
Natco Pharma Limited (NSE: NATCOPHARM , BSE: 524816) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical,Inc., has received a tentative approval from the United States Food & Drug Administration (USFDA) for Armodafinil 50mg, 150mg, and 250mg Tablets.
Breckenridge filed the Abbreviated New Drug Application (ANDA) with a Paragraph IV certification to obtain approval to engage in the commercial manufacture,use and sale of its generic to Nuvigil® prior to expiration of the listed patents. Natco and Breckenridge have entered into a settlement regarding the ANDA with Cephalon, the terms of which are confidential. Cephalon has granted Natco and Breckenridge a license to market generic versions of the 50mg,100 mg, 150mg, 200 mg and 250mg strengths of Nuvigil®, beginning 180-days after the initial launch of these strengths .
Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under Brand name Nuvigil® in the USA market. Nuvigil® is a wakefulness promoting agent for oral administration . The market size of Nuvigil® in the USA is approximately US $457 Million for twelve months ending August 2014,according to IMS Health.
All trademarks are the property of their respective owners.
Natco’s Kothur Formulation Facility found acceptable by USFDA 18 September 2014
Natco’s Kothur Formulation Facility found acceptable by USFDA Natco has received a letter dated July 14th 2014 after completing review of the Establishment Inspection Report (EIR) for the inspection conducted from May 19th to 23rd, 2014.
The Facility was classified as acceptable. The Company has made proposed commitments and corrective actions based on the minor and routine observations during inspection. We continue to manufacture and sell products in the US. We strongly deny all adverse speculations against the Company.
Breckenridge/NATCO files ANDA for Everolimus, 0.25mg, 0.5mg, and 0.75mg Tablets 05 September 2014
Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical, Inc. (BPI), has filed an Abbreviated New Drug Application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets.
Natco and BPI believe that its Paragraph IV ANDA was filed on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period.
Novartis AG sells Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets under Brand name Zortress® in the USA market. Zortress® is used to prevent organ rejection after a kidney or liver transplant. Zortress® generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data.
Zortress® is a trademark of Novartis AG or its affiliates.
NATCO's marketing partner, Mylan Inc., files ANDA For Three Times Per Week Generic Copaxone® 40 mg/mL 30 August 2014
Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Mylan Inc. (Nasdaq: MYL), has filed an Abbreviated New Drug Application (ANDA) for a three-times-a-week generic COPAXONE® (glatiramer acetate injection, 40 mg/mL) and has been accepted by the U.S. Food and Drug Administration (US FDA).COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
Natco’s partner Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva.Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to IMS Health.
NATCO records Rs.33.46 crores profit for the First Quarter ended June 2014 13 August 2014
NATCO records Rs.33.46 crores profit for the First Quarter ended June 2014.
Hyderabad based NATCO Pharma Limited has recorded an aggregate of Rs.211.48 Crores in consolidated net revenues for the quarter ended on 30th June, 2014, as against Rs. 176.01 Crores during the same quarter last year, recording an increase of about 20%. The net profit, after tax, on a consolidated basis, improved to Rs. 33.46 Crores, as against Rs. 21.78 Crores same quarter last year reflecting a 54% jump.
Natco pleased with Bombay High Court decision to uphold Compulsory License on Nexavar issued to the Company 15 June 2014
Natco is pleased to inform that the Bombay High Court upheld the compulsory license (CL) granted to the Company on Nexavar (sorafenib tosylate) of German drug Major Bayer’s patented kidney cancer drug.
The Nexavar issue dates back to March 9, 2012, when the then Controller General of Patents issued the first-ever CL to the Company to manufacture an affordable generic version of sorafenib tosylate, the anti-cancer drug for which Bayer had obtained a patent.
NATCO records Rs.103 crores profit for the year ended March 2014 30 May 2014
NATCO records Rs.103 crores profit for the year ended March 2014
The Board of NATCO Pharma met at Hyderabad today and adopted the consolidated audited accounts of the company for the year ended 31st March, 2014.
The Company had posted a 13% increases in its gross revenues at Rs.200 Crores for the quarter ended 31st March, 2014, as against Rs.176 Crores for the same quarter last year. The net profit after tax for the quarter ended 31st March, 2014 was Rs.24.02 Crores (as against Rs.11.32 Crores last year).
The Company had posted a 11% increase in its gross revenues at Rs.781 Crores for the year ended 31st March, 2014 – as against Rs.705 Crores during the last year. The Company had earned a profit after tax of Rs.103 Crores against Rs.72 Crores last year.
The turnover and the profit growth was driven by strong performance on account of export of Finished Dosage formulations to North America & South America in addition to growth in the domestic Oncology products division by 17%.
Breckenridge/NATCO files ANDA For Bendamustine Hydrochloride powder 28 April 2014
Natco Pharma Limited (NSE: NATCOPHARM) announced today that its marketing partner in the USA, Breckenridge Pharmaceutical, Inc., has filed an Abbreviated New Drug Application (ANDA) for Bendamustine Hydrochloride powder; IV infusion (25mg/vial and 100mg/vial).
Breckenridge’s ANDA includes a paragraph IV certification to obtain approval to engage in the commercial manufacture, use or sale of the drug before expiration of the ‘190, ‘524, and ‘863 patents. Natco and Breckenridge believe that the ANDA was filed on the first-to-file date, providing 180 days of exclusivity.
Teva (Cephalon) sells Bendamustine Hydrochloride under Brand name TREANDA, used as a chemotherapy medicine in oncology segment. The market size of Bendamustine Hydrochloride in the USA is approximately US$660M for twelve months ending September 2013, according to IMS Health.
NATCO Pharma pleased with Federal Circuit’s decision on Oseltamivir 24 April 2014
Natco Pharma Limited and Alvogen, who have partnered with respect to the first substantially complete Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) for the generic version of Tamiflu® oral capsules (oseltamivir phosphate), are pleased with the Federal Circuit’s decision of April 22nd in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, 2013-1418.
In it, Circuit Judges Chen and Prost agreed with Natco and Alvogen that the earlier expiring Orange Book listed patent qualifies as an obviousness-type double patenting reference for the later expiring Orange Book listed patent. The case has been remanded to the District court of New Jersey where Natco and Alvogen will continue to challenge the validity of U.S. Patent No. 5,763,483.Natco may have First to File approval status for the Abbreviated New Drug Application (ANDA), contingent upon successful litigation outcome.
TAMIFLU® (Roche’s trade name for Oseltamivir Phosphate) had U.S. sales of approximately $495 Million for twelve months ending September 2013, according to IMS Health.
Supreme Court Chief Justice denies Teva's Request for an Injunction Relating to Generic Copaxone®; Clears Legal Hurdle for Mylan & Natco to Launch the same at Market Formation 21 April 2014
NATCO today announced that Supreme Court Chief Justice Roberts has denied Teva's application for an injunction seeking to prevent launch of a generic version of Copaxone@reg; pending the Supreme Court's decision on Teva's appeal. This is the second time that the Chief Justice has denied Teva's request for such an injunction.
Natco clarifies in response to speculation about Generic Copaxone 03 April 2014
Natco today issues a clarification with regard to launch of generic Copaxone. There has been recent speculation as to the role of Natco in the future decision(s) related to potential launch and/ or pricing of generic Copaxone in the United States. Natco confirms the final decision as to when or whether and pricing of generic Copaxone is launched in the US rests with its Partner Mylan. Natco remains committed and working to take steps and deploy the necessary resources to ensure that a quality generic US FDA approved Copaxone is made available to patients suffering from Multiple Sclerosis upon market formation. The Stock Exchange will be duly informed whenever such a decision is made in the future.
NATCO comments on Copaxone patent 01 April 2014
NATCO Pharma ltd. today informs the exchange that the US Supreme Court agreed to hear appeal in a patent fight on Copaxone. The company continues to believe that Teva's '808 patent is invalid for indefiniteness.
NATCO Comments on Decision by New Delhi High Court Against Teva 01 March 2014
Natco Pharma Ltd. today commented on the New Delhi High Court’s decision to dismiss a lawsuit related to applications filed by Teva Pharmaceuticals Industries Ltd., Yeda Research and Development Co. Ltd. and Teva API India Limited (“Teva”). Teva had alleged that Natco’s use in India of the well-known process to manufacture copolymer-1 infringes Yeda’s Indian Patent No. 190759(“IN’759”).
Natco commented, “We are very pleased with the decision by the New Delhi High Court to dismiss and take no action in this matter. We continue to believe that the sole Indian process patent is invalid, as reinforced by the outcomes of numerous other legal proceedings. We also are pursuing other challenges against this patent.”
In addition to defending against Teva’s actions in the New Delhi High Court, the company is pursuing other challenges against the IN’759 patent, including a petition to the New Delhi High Court to invalidate the patent. The hearing on this petition has been set for 5 March 2014. Further, the Indian Patent Office refused to grant two additional patent applications, which would have covered the copolymer-1 product.
The U.S. counterpart to the IN’759 patent, U.S. Patent No. 5,800,808, along with four other U.S. patents, was held to be invalid by the U.S. Court of Appeals for the Federal Circuit last July. All of Teva’s further appellate attempts have been unsuccessful to date.
NATCO exhibits improved results, recommends Rs. 5 interim 14 February 2014
Hyderabad based NATCO Pharma Limited had exhibited improved operating results for the quarter ended 31st December, 2013.
Aggregate revenues went up to Rs. 181.70 Crores (from Rs. 163.38 Crores during the same quarter last year), while the profit after tax went up to Rs. 32.42 Crores (from Rs. 24.37 Crores during the same quarter last year).
On a consolidated basis, the revenues for the quarter went up to Rs. 211.05 Crores (from Rs. 190.91 Crores during the same quarter last year), while the profit after tax went up to Rs. 29.88Crores (from Rs. 22.59 Crores during the same quarter last year).
Rs. Lakhs
| Particulars |
For the quater ended 31-12-2013 |
For the quater ended 31-12-2012 |
| Stand-alone gross revenues |
18170 |
16338 |
| Stand-alone profit after tax |
3242 |
2437 |
| Consolidated gross revenues |
21105 |
19091 |
| Consolidated profit after tax |
2988 |
2259 |
The Board has recommended payment of an interim dividend of Rs. 5 per share, payable on 6th March, 2014.
NATCO records higher profits 14 November 2013
Hyderabad based NATCO Pharma Limited has recorded higher profits for the quarter ended 30th September, 2013.
For the quarter ended 30th September, 2013, on a consolidated revenue base of Rs. 188 Crores, the company earned a net profit after tax, of Rs. 27 Crores as against Rs. 21 Crores on a revenue base of Rs. 191 Crores last year.
The EBIDTA margins have expanded to 31% of the revenues, from 26% last year. The growth has been driven by value-added formulation exports during the quarter.
Natco EGM Notice 24 October 2013
NATCO turns out better performance 14 August 2013
Hyderabad based NATCO Pharma Limited has clocked an aggregate of Rs.182 Crores in consolidated
Revenues for the quarter ended on 30th June, 2013, as against Rs. 151 Crores during the same quarter last year, recording an increase of around 21%. The net profit, after tax, on a consolidated basis, improved to Rs.2178 lakhs, as against Rs. 1707 lakhs same quarter last year. This amounts to an increase of around 28%.
On a stand-alone basis, the revenues improved by 23% (Rs. 154 Crores as against Rs. 125 Crores), while the net profit after tax, improved by 25% (Rs. 2274 lakhs as against 1818 lakhs).
API exports and finished dosage pharmaceutical formulations exports continue to drive the growth.
With a favorable verdict having been received from the Federal Circuit Court, the Company is awaiting US FDA approval of its ANDA for Glatiramer Acetate (Copaxone®) for a possible launch in May 2014 in association with Mylan Inc.
NATCO obtains a favorable ruling on Copaxone® 27 July 2013
NATCO Pharma Limited is pleased to announce the US Court of Appeals for the Federal Circuit ruling, reversing a district court’s finding related to Teva’s US Patent for Copaxone®.
This would essentially mean that NATCO could launch the generic Copaxone – through its marketing partner – Mylan Inc., during May 2014, subject to FDA approval.
Copaxone® (Glatiramer Acetate) is used in the treatment of relapsing-remitting multiple sclerosis.
The product is estimated to have clocked revenues, in USA, of about US $ 3.45 Billion during 2012.
NATCO announces marketing approval for Rizatriptan (ODT), commences shipments 03 July 2013
NATCO Pharma Limited is pleased to announce the receipt of marketing approval for its Rizatriptan Benzoate (Maxalt-MLD) – orally disintegrating tablets, 5 mg and 10 mg (base). The Company has already commenced shipments of the product, which is being launched by its marketing partner – Breckenridge Pharmaceuticals. Rizatriptan is used to treat migraine headaches with or without aura (warning signs that occur prior to the onset of a migraine headache).
NATCO estimates the market to be around US $ 250 Million (before generic launch – as of December, 2012).
NATCO posts higher revenues, profits !!! 30 May 2013
The Board of NATCO Pharma met at Hyderabad today to adopt the stand-alone audited accounts of the company for the year ended 31st March, 2013.
The Company had posted a 14% increases in its net revenues at Rs. 143 Crores for the quarter ended 31st March, 2013, as against Rs. 126 Crores for the same quarter last year. The net profit after tax for the quarter ended 31st March, 2013 was 11.72 Crores (as against Rs. 14.53 Crores last year). The profit would have been higher, but for an additional non-cash deferred tax liability of Rs. 7 Crores during the quarter, due to increased capital expenditure.
The Company had, however, posted a 28% increase in its net revenues at Rs. 559 Crores for the year ended 31st March, 2013 – as against Rs. 435 Crores during the last year. The Company had earned a profit after tax of Rs. 78 Crores against Rs. 62 Crores last year.
The strong performance was driven by a 51% growth in the revenues from the active pharmaceutical ingredients segment (Rs. 223 Crores as againt Rs. 148 Crores last year), and a 58% increase in revenues from the finished dosage pharmaceutical formulation exports (Rs. 103 Crores as against Rs. 65 Crores last year). The company expects to grow at 15% - 20% this financial year.
NATCO Pharma records improved results, declares 40% interim 13 February 2013
Hyderabad based NATCO Pharma Limited has recorded improved operating results for the quarter and nine-months ended on 31st December, 2012.
The Board has also recommended payment of an interim dividend of Rs.4 per equity share, payable on 6th March, 2013
The following are the highlights of the consolidated operational performance.
Rs.Lakhs
|
Quarter Ended On |
Nine Months Ended On |
|
31-Dec-2012 |
31-Dec-2011 |
31-Dec-2012 |
31-Dec-2011 |
| Gross Revenues |
19091 |
14578 |
53240 |
40450 |
| Profit Before Tax |
3320 |
2204 |
8377 |
6185 |
| Profit After Tax |
2259 |
1700 |
6054 |
4696 |
| Increases in Revenues (YOY) |
31% |
|
|
32% |
| Increase in PAT |
33% |
|
|
29% |
The increase in revenues was driven by API and formulation exports. Out of the total revenues for the nine months period ended on 31st December, 2012, exports accounted for 47% at Rs. 213 Crores.
NATCO receives USFDA approval, all set to launch Lansoprazole 19 December 2012
NATCO Pharma Limited is pleased to announce the approval by US FDA, of its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed Release Capsules, USP, 15 mg and 30 mg. for the prescription market.
Shipments of this product will commence immediately.
NATCO reports improved performance 08 November 2012
The Board of Directors of the Hyderabad based NATCO Pharma Limited, met today and took on record the operational performance of the Company for the quarter and half-year ended on 30th September, 2012.
The Company has recorded a consolidated revenue base of Rs. 191 Crores for the quarter ended on 30th September, 2012 (up by 26% on a sequential basis and by 41% on a year-on-year basis). The profit after tax at Rs. 21 Crores also grew by 24% on a sequential basis and by 31% on a year-on-year basis.
The growth in revenues and profitability was driven by increased sales of APIs and exports of finished dosage pharmaceutical formulations.
For the half-year ended on 30th September, 2012, the consolidated revenues stood at Rs. 341 Crores, recording an increase of 32% as compared to the half-year ended on 30th September, 2011. The profit after tax for the half year stood at Rs. 38 Crores as compared to Rs. 30 Crores for the half-year ended on 30th September, 2011, recording an increase of 27%.
Exports, at Rs. 85 Crores, constituted 52% of the revenues of the Company for the quarter ended on 30th September, 2012. At Rs. 127 Crores, they constituted 44% of the revenues for the half year ended on 30th September, 2012.
Rajeev takes over as Vice Chairman & Chief Executive Officer 21 June 2012
NATCO Pharma Limited, Hyderabad, is pleased to announce the elevation of Mr.Rajeev Nannapaneni to the position of Vice Chairman & Chief Executive Officer.
Rajeev, who joined the Board in 2005, was till now the Chief Operating Officer.
Thirty five year old Rajeev has many accomplishments to his credit. Rajeev completed B.A. Honors (Double Major in Economics and History) from Tufts University, Boston, U.S.A., and after a short stint with Merrill Lynch, USA, as a Financial Analyst, joined the company in 2000. Rajeev has been instrumental in helping the company evolve business strategies that ultimately resulted in NATCO becoming one of the fastest growing companies in the Indian Pharma space. Taking forward the company’s mission of making available life saving medicines at an affordable cost, Rajeev ensured that the Company got on to the Oncology bandwagon in 2003, far ahead of competition and also achieved the enviable record of making the company far ahead of others in terms of revenues from this segment amongst the Indian companies. A champion of the “cheaper generic drugs”, Rajeev was instrumental in NATCO obtaining the first ever compulsory license in India for the generic version of Bayer’s Nexavar – a drug used in the treatment of kidney and liver cancers.
Particular mention must be made of NATCO’s ability to take on global pharmaceutical giants – often challenging their R & D capabilities and ensuring that generic drugs are available at a fraction of the innovator’s price. This strategy has paid off and today NATCO has several para IV and firstto-file opportunities ready and the company is in a position to encash multi-Billion marketing opportunities.
Rajeev would be incharge of all day-to-day operations of the Company and would oversee all functional areas.
NATCO records increased revenues, profits!!! 28 May 2012
The Hyderabad based NATCO Pharma Limited has recorded increased revenues and profits for the financial year ended on 31st March, 2012. The Board met at Hyderabad today and approved the accounts.
The Company has recorded aggregate revenues of Rs. 559 Crores (an increase of 15% over 2011- Rs. 484 Crores) and earned an after tax profit of Rs. 60 Crores (an increase of 12% over 2011 – Rs. 53 Crores).
The growth was driven by a 40% increase in API sales at Rs. 148 Crores from Rs. 106 Crores during 2011, a 22% increase in Formulation sales at Rs. 282 Crores in 2012 from 232 Crores in 2011. The company’s oncology division performed well, recording an increase in sales from Rs. 121 Crores in 2011 to Rs. 148 Crores in 2012. The company’s exports aggregated to Rs. 183 Crores, an increase of 37% over that of 2011 (Rs. 134 Crores).
Natco bagged Golden Peacock Award 2012 27 April 2012
Natco Pharma Limited has been selected as the National Award winner of the ‘Golden Peacock Award for Corporate Social Responsibility’ for the year 2012 by the awards Jury under the Chairmanship of Justice P.N.Bhagwati, former Chief Justice of India and Member, UN Human Rights Commission.
The award was presented at a specially organized “Awards Gala Nite” on Wednesday, 25 April 2012 in Dubai in the presence of distinguished gathering of business leaders, jurists, academics, environmentalists, economists, legislators and policy makers during the Dubai Global Convention incorporating the 7th International Conference on Social Responsibility, which was held on 24 – 26 April 2012 in Dubai.
Natco Pharma Limited is the first Indian Pharma Company which received the award from His excellency Dr.Abdulrahman A., Al-Alwar, Director-General, Federal Authority for Government Human Resources (FAHR) in the august presence of Justice M.N.Venkatachaliah, Former Chief Justice of India, His excellency Mr.Juma Al Majid, Chairman of Dubai Economic Council & Founder Chairman of Juma Al Majid Group also present. Natco Pharma Limited has bagged the award under stiff competition which shows and proves its commitment to the Corporate Social Responsibility.
NATCO granted compulsory licence for Nexavar 12 March 2012
The Hyderabad based NATCO Pharma Limited is pleased to announce the granting of a compulsory licence to it, under the provisions of Section 84 of the Indian Patents Act, 1970 for Sorafenib Tosylate (Brand Name : Nexavar owned by Bayer Corporation). Nexavar is the first-line treatment for liver and kidney cancer.
The Compulsory License, first of its kind granted, enables NATCO to sell the drug at a price not exceeding Rs. 8880 for a pack of 120 tablets (one month’s therapy) against Rs. 284,428 being the cost of Naxavar sold by Bayer. The license is valid till the expiry of the patent – 2021.
The order is subject to certain conditions such as maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis etc. The order also makes it obligatory for NATCO to supply the drug free of cost to at least 600 needy and deserving patients per year.
NATCO welcomes this order and opines that this opens up a new avenue of availability of life savings drugs at an affordable price to the suffering masses in India.
NATCO declares interim dividend; Sales, Profits up !!! 09 February 2012
Hyderabad based NATCO Pharma Limited has posted an aggregate revenues of Rs. 405 Crores for the nine month period ended on 31st December, 2011, an increase of 10% over that recorded for the nine month period ended on 31st December, 2010. The company posted a net profit, after tax, of Rs. 47 Crores (Rs. 39 Crores for 2010) for the nine month period ended on 31st December
The revenues for the quarter ended on 31st December, 2011 stand at Rs. 145 Crores as compared to Rs. 133 Crores for the three months ended on 30th September, 2011. The net profit after tax, for the same period stand at Rs. 1700 lakhs as compared to Rs. 1594 lakhs.
The growth was driven by increased API sales and formulation exports.
The Board had recommended the payment of an interim dividend of Rs. 3/- per share. (2010- Rs. 2/- per share).
NATCO records increased turnover,profitability 09 November 2011
The Hyderabad based NATCO Pharma Limited has recorded increased turnover and profitability for the quarter and half-year ended on 30th September, 2011.
The stand-alone revenues, for the quarter ended on 30th September, 2011 grew (from Rs. 9455 lakhs) to Rs. 11449 lakhs, on a year-on-year basis, recording an increase of 21%. The net profit after tax, for the same period, grew (from Rs. 1472 lakhs) to Rs. 1603 lakhs, recording an increase of 9%.
For the half year ended on 30th September, 2011, the revenues recorded an increase of 18% from Rs. 18497 lakhs as at 30th September, 2010 to Rs. 21740 lakhs as at 30th September, 2011. The net profit, after tax, for the same period grew (from Rs. 2516 lakhs) to Rs. 2980 lakhs, recording an increase of 18%.
The growth was driven by revenues from API division, (from Rs. 50 Crores to Rs. 77 Crores) on a year-on-year basis for the half-year ended on 30th September, 2010 and 2011.
NATCO to enter bio-generics (mAbs), signs up with Mabxience 19 October 2011
Hyderabad based NATCO Pharma Limited has entered into an exclusive agreement with Mabxience, the bio-similar division of Chemo Sa Lugano, Switzerland, an integrated healthcare multinational involved into different fields of pharmaceutical business, including bio-similars and branded pharmaceuticals.
Under the agreement, NATCO will purchase four mAb drug substances from Chemo and use the same for manufacturing finished dosage pharmaceutical formulations. Three of these products viz., Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment, while Etanercept is for auto-immune disease. NATCO’s obligations under the agreement will include manufacture of drug products, undertake local clinical trials, filing registration of dossiers, to apply for market authorizations and to commercialize the product in India and a few other Asian countries.
Oncology is the largest therapy area within the mAb market, with eight marketed products. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies, with insignificant generic presence.
World-wide, the market for mAbs has grown rapidly and is currently at a revenue level of around US $ 35 Billion.
With the product combinations chosen by NATCO, the mAb initiative is likely to be completed in a period of 24 to 36 months.
NACTO Records Higher Profits 12 August 2011
Hyderabad based NATCO Pharma Limited had recorded increased profits for the first quarter (April 2011 - June 2011) of the current fiscal 2011-12.
The consolidated revenues for the quarter ended 30th June, 2011 stood at Rs 123 Crores and would have been higher, but for the sale of one of the retail pharmacy stores in the USA. However, the profit after tax grew by over 32% - from Rs.1059 Lakhs (same quarter last year) to Rs.1403 Lakhs (current year).
The Company recorded an earnings per share of Rs.4.98 (non-annualized basis).
During the current quarter, the company had filed an ANDA for Lapatinib Ditosylate 250mg tablets. The company believes that it has a first -to-file opportunity for this product. The sales of this product amounted to over US $ 114 Million last year. The company has tied-up with Lupin Limited for supply and marketing of this product.
With this product, the Company has five para IV challenges, out of which four products are with a first-to-file opportunity.
NATCO launches Anastrazole in the USA 29 June 2011
NATCO Pharma Limited is pleased to announce the launch, in the United States of America, of the generic version of Anastrazole 1 mg. tablets, consequent to the final approval received from the US FDA.
The product has been launched through the company's marketing partners.
The company recorded an EPS of Rs. 17.31 on a consolidated basis for the year 2010, as against Rs. 15.62 last year.
Anastrazole is used in the treatment of breast cancers and the market for this product in the USA is expected to be in the region of US $ 750 Million per annum. The company is confident of gaining a reasonable share of the market.
NATCO launches BENDIT 07 April 2011
Hyderabad based NATCO Pharma is pleased to announce the commercial launch of its brand - BENDIT - Bendamustine - a novel agent in the treatment of Chronic Lymphocytic Leukemia (CLL), mostly seen in the elderly people.
Bendamustine is a unique hybrid cytotoxic, which is mechanistically distinct from the existing options. Response rates to Bendamustine are reported to be high and durable, and the therapy is seen as a superior and tolerable first line option in the treatment of CLL.
Bendit is the generic version of Treanda, the innovator brand, which is priced at around Rs.86,000 per vial of 100mg. Bendit is aggressively priced at Rs.6,950 per vial of 100mg., in accordance with NATCO'S policy of making available quality medicare at an affordable price.
NATCO is exploring the possibility of introducing this product in international markets as well.
NATCO files ANDA for Oseltamivir, ties up with Alvogen, gets First to File Status 19 February 2011
The Hyderabad based NATCO Pharma Limited is pleased to announce the acceptance of its Abbreviated New Drug Application for the generic version of Oseltamivir Phosphate capsules.
Oseltamivir Phosphate is used in the treatment of bird and swine-flu infections. NATCO has tied up with the Luxemborg based Alvogen IPCO S.a.r.l., for marketing and sales of Oseltamivir Phosphate in the USA.
NATCO is the "first applicant" to file an ANDA for the generic version of Oseltamivir and, should the ANDA be approved, may be entitled to 180 days of generic market exclusivity.
NATCO records higher earnings, higher profits 14 February 2011
The Board of the Hyderabad based NATCO Pharma Limited had recommended an interim dividend of Rs. 2 per share, payable on 10th March, 2011.
The Board, which met in Hyderabad today, considered the financial results of the Company for the quarter and nine months ended on 31st December, 2010.
The Company recorded revenues of Rs. 118 Crores for the quarter (Rs. 367 Crores for the nine -month period) ended on 31st December, 2010, as against Rs. 117 Crores and Rs. 347 Crores for the same period last year.
The company earned a net profit, after tax, of Rs. 1372 lakhs (up by 13%) for the quarter and Rs. 3913 lakhs for the nine month period ended on 31st December, 2010 as against Rs. 1214 lakhs and Rs. 3368 lakhs respectively for the same period last year. The company has accounted for a loss of nearly Rs. 300 lakhs on account of the sale of one of the retail stores in USA.
K & C Pharmacy, a general partnership firm based out of New Jersey 14 January 2011
K & C Pharmacy, a general partnership firm based out of New Jersey, USA (of which the Hyderabad based NATCO Pharma Limited is a 75% partner) has sold its right, title and interest in a retail pharmacy outlet known as Nicks' Drugs, based in Newark, New Jersey.
Nicks' Drugs revenues were predominantly guided by the Medicaid reimbursements from the State of New Jersey. Of-late, however, owing to budgetary restrictions, there have been significant reductions in the reimbursements. However, this sale would not have any significant effect on the revenues and profitability of NATCO Pharma Limited.
With this sale, NATCO Pharma Limited now owns and operates only one retail pharma store -through its wholly owned subsidiary - NATCOPharma Inc., - known as SaveMart Pharmacy, based in Lancaster, Pennsylvania, USA. This store is doing well and is not dependent on Medicaid reimbursements.
Press Release 09 January 2011
NATCO Pharma Limited is pleased to announce that the Government of India has stayed the suspension of its Albupax manufacturing (product) license. Albupax is a nanotechnology based drug and is the first generic version of the international brand
- Abraxane® of Abraxis Bioscience Inc., USA.
Albupax consists of Paclitaxel in an Albumin-bound nanoparticle form and is used in the treatment of breast cancer. NATCO'S manufacturing license was suspended by the Drugs Controller General of India (DCGI), allegedly for not passing the test measuring endotoxin levels.
Subsequently, NATCO appealed to the Government of India under the provisions of the Drugs & Cosmetics Rules against the suspension order. Among other things, NATCO pleaded that:
- The testing methods used to evaluate nanotechnology based protein-bound formulations are highly complex and variable. An appropriate test method needs to be employed to test such products.
- The product has been aggressively priced at a fraction of the innovator’s price
- The product was received well by the medical fraternity as well as patients from various parts of India.
NATCO is thankful to the Government for its decision in this regard. NATCO stands by its commitment to provide high quality and life saving drugs at affordable price to Indian patients.
NATCO would announce its future plans shortly.
