Pharma Focus Asia

Cipla signs license agreement with Gilead for extended access to COVID-19 treatment

Thursday, May 14, 2020

Cipla Limited announced the signing of a non-exclusive manufacturing and manufacturing license agreement with Gilead Sciences, Inc. Distributor of the drug product Remdesivir, which has received approval from the US Food and Drug Administration (FDA) for use in emergency situations (Emergency Use Authorization, EUA) for the treatment of COVID-19 patients Cipla is committed to increasing global access to life-saving treatments for patients affected by this pandemic.

Under the agreement, Cipla is empowered to manufacture the API and finished product and to distribute it under Cipla's own brand name in 127 countries, including India and South Africa. Gilead Sciences, Inc. will provide Cipla with the manufacturing knowledge necessary to manufacture the API and end product on a commercial scale. Cipla's extensive geographic and commercial presence will help make this therapy accessible to more patients and markets.  

According to the World Health Organization (WHO) tracker, the number of COVID-19 cases reported worldwide has exceeded the four million mark.

Through the EUA, remdesivir can be used more to treat hospitalized patients with severe COVID-19 symptoms. The EUA is based on available data from two global clinical trials: the Placebo-controlled Phase III study in patients with moderate to severe COVID-19 symptoms from the US National Institute for Allergy and Infectious Diseases and the Gilead Global Phase III study Evaluation of remdesivir in seriously ill patients. Several additional clinical trials are ongoing to collect further data on the safety and efficacy of remdesivir as a potential treatment for COVID-19. Remdesivir is still an investigational product without FDA approval.

Umang Vohra , MD and Global CEO of Cipla Limited, commented the partnership as follows: “Given the global COVID 19 crisis, it is imperative that we join forces in the fight against this virus. We are delighted to partner with Gilead to provide this treatment to patients in numerous countries after we have received regulatory approvals. At Cipla, we continuously strive to ensure that no patients are denied access to life-saving treatments. Our partnership with Gilead illustrates this tireless commitment and is a significant step in saving millions of lives at risk from this pandemic. "

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024