Bharat Biotech, Ocugen ink pact for commercialisation of Covaxin in US
Under the terms of the agreement, Ocugen will have the US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including emergency use authorisation (EUA)) and commercialisation for the US market.
Hyderabad: Ocugen, a biopharmaceutical company, and Bharat Biotech have entered into a definitive agreement to co-develop, supply and commercialise Bharat Biotech’s Covaxin for the United States market.
Under the terms of the agreement, Ocugen will have the US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including emergency use authorisation (EUA)) and commercialisation 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 per cent of the profits.
In preparation for the development of Covaxin in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the US 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 immunisation programme.
“Requiring only a standard vaccine storage temperature of 2–8° C and with the potential to treat all age-groups, Covaxin may offer an important option to protect lives across America,” said Dr Shankar Musunuri, chairman of Ocugen.
“Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist. With the recent progression of Covaxin use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring Covaxin to the US market,” said Dr Krishna Ella, CMD, Bharat Biotech.
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