Bharat Biotech to export Covaxin to US

Ocugen Inc and Bharat Biotech on Tuesday announced they have entered into a definitive agreement to co-develop, supply and commercialise Bharat Biotech’s Covaxin, an advanced stage whole-virion inactivated Covid-19 vaccine candidate, for the United States market. 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.

The Central Licensing Authority in India has granted permission for the sale or distribution of COVAXIN for restricted use in emergency situations in the public interest, in clinical trial mode.