Covaxin heads to the US
CITY-based Bharat Biotech, a global leader in vaccine innovation, and Nasdaq-listed biopharmaceutical company Ocugen Inc, 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 US market.
image for illustrative purpose
Hyderabad: CITY-based Bharat Biotech, a global leader in vaccine innovation, and Nasdaq-listed biopharmaceutical company Ocugen Inc, 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 US 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 commercialisation for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen's receipt of an emergency use authorization (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.
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 immunization program.
"The evaluation of Covaxin has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. 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.
