Hyderabad-based Bharat Biotech has entered into an exclusive deal with US biopharmaceutical company Ocugen to commercialise Covaxin, the first indigenous coronavirus vaccine developed in India, in 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 EUA from the US regulatory authorities.
In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. Ocugen will share the profits from the sale of the vaccine in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits. 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 program, said company sources.
"With the recent progression of Covaxin use under emergency use authorisation (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 Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech. Our goal for all vaccines developed at Bharat Biotech is to provide global access, he said.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The vaccine is being administered as one of the two COVID-19 shots available under emergency authorisation in India with the first batch of 30 million doses being administered to health professionals and front-line workers. It is also undergoing a fully enrolled Phase 3 clinical trial involving 25,800 patients.
"Requiring only a standard vaccine storage temperature of 2-8 degree celsius and with the potential to treat all age-groups, Covaxin may offer an important option to protect lives across America," said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. Ocugen is focused on discovering, developing, and commercialising gene therapies to cure blindness diseases and is also developing a vaccine to fight Covid-19.