Nasdaq-listed biopharmaceutical firm Ocugen and Bharat Biotech have entered into a definitive agreement to co-develop, supply and commercialise Covaxin for the U.S. market. Ocugen will have U.S. rights to the vaccine candidate. It will be responsible for clinical development, regulatory approval, including EUA and commercialisation for the U.S. market. Initial doses, for use in the U.S., will be supplied by the Indian vaccine maker.
Ocugen, in consideration for the exclusive license to the U.S. market, will share profits with Bharat Biotech from the sale of Covaxin in the U.S. Ocugen will retain 45% of the profits, a joint statement on Tuesday said.
Covaxin, which Bharat Biotech has developed with ICMR-NIV, is a whole-virion inactivated vaccine. It is approved for restricted use in emergency situations in clinical trial mode by the Drugs Controller General of India (DCGI). The first batch of 30 million doses of the vaccine since last month is being administered to health professionals and frontline workers.
In December, Ocugen and Bharat Biotech had signed a binding letter of intent to co-develop Covaxin for the U.S market. The release on their definitive agreement said the collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for the development of Covaxin in the U.S., Ocugen’s Vaccine Scientific Advisory Board and management had initiated discussions with the USFDA and the Biomedical Advanced Research and Development Authority to develop a regulatory path to EUA and eventually, biologics license application approval in the US market.
Ocugen is also in active discussions with manufacturers in the U.S. to produce a significant number of doses of Covaxin to support its US immunisation programme, the release said. Chairman, CEO and co-founder of Ocugen, Shankar Musunuri, said “requiring only a standard vaccine storage temperature of 2-8 degree C and with potential to treat all age-groups, Covaxin may offer an important option to protect lives across America.”
Bharat Biotech CMD Krishna Ella said Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.