Hyderabad, (Asian independent) 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, a biopharmaceutical company focused on discovering, developing, and commercialising gene therapies to cure blindness diseases and developing a vaccine to fight Covid-19, 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.
Hyderabad-based Bharat Biotech said in a statement that 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.
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 & 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.
“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.
Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, Covaxin may offer an important option to protect lives across America,” said Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
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.
“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 Krishna Ella, Chairman & Managing Director of Bharat Biotech.