Bharat Biotech indicators settlement for commercialisation of COVAXIN in US market


Tribune News Service

New Delhi, February 2

Ocugen, a biopharmaceutical company focused on discovering, developing, and commercialising gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Indian firm 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.

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 Emergency Use Authorisation) 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% 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 US Food and 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.



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