Ocugen and Bharat Biotech Announce Execution of Definitive Agreement for the Commercialization of COVAXIN in the US Market
Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN for the US market
- Ocugen and Bharat Biotech to share US commercialization profits
- Ocugen to receive initial supply of COVAXIN doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US
- COVAXIN received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients
COVAXIN (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape
MALVERN, Pa. and HYDERABAD, India, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
The collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for the development of COVAXIN in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN to support its US immunization program.