Ocugen, a Pennsylvania-based pharmaceutical company, has signed an agreement with Bharat Biotech, an Indian pharma developer of COVAXIN, a Covid-19 vaccine, to distribute the vaccine in the US.
With the distribution agreement, Ocugen will have the rights to the vaccine candidate in the US and will also be accountable for clinical development, regulatory approval and commercialisation in the US market.
After Ocugen secures emergency usage authorisation (EUA) from the US Food and Drug Administration (FDA), Bharat Biotech will supply the initial doses of COVAXIN.
Furthermore, the Indian company has also agreed to offer technology transfer support to manufacture the vaccine candidate in the US.
As a consideration for gaining the exclusive licence of COVAXIN, Ocugen will share the profits from the sale of the vaccine candidate with Bharat Biotech, retaining 45% of the profits.
Ocugen chairman, CEO and co-founder Shankar Musunuri said: “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 neutralising 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.”
Ocugen aims to use its vaccine expertise to support their path towards securing approval from the FDA.
As part of the preparation to develop the COVAXIN in the US, Ocugen has begun discussions with the FDA and the Biomedical Advanced Research and Development Authority (BARDA) for the regulatory path to obtain EUA and eventually biologics license application (BLA) approval.
The company is also in discussions with US manufacturers to produce a significant number of the COVAXIN doses to support the immunisation programme in the US.
Bharat Biotech chairman and managing director Krishna Ella said: “The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. Our goal for all vaccines developed at Bharat Biotech is to provide global access.
“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.”
Last month, India’s Central Drugs Standard Control Organisation (CDSCO) has given restricted emergency use approval for Covid-19 vaccines developed by Bharat Biotech and Serum Institute of India.