(Representative image)
HYDERABAD: Vaccine maker Bharat Biotech has inked a binding letter of intent (LoI) with US-based biopharmaceutical player Ocugen Inc for co-developing India’s first indigenous Covid-19 vaccine candidate Covaxin for the US market.
Covaxin, which is a whole-viron inactivated vaccine candidate developed on the vero cell manufacturing platform, is currently undergoing Phase III human clinical trials in India on 26,000 volunteers after having undergone Phase I and II trials involving 1,000 volunteers.
As per the LoI, Ocugen will have the US rights to Covaxin and in collaboration with Bharat Biotech will take up clinical development, registration, and commercialisation of the vaccine candidate for the US market.
Coronavirus Vaccine Update | Ocugen, Bharat Biotech To Co-develop Covaxin For US Market moneycontrol.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from moneycontrol.com Daily Mail and Mail on Sunday newspapers.
‘Promising safety’ spurs decision
U.S. biopharmaceutical firm Ocugen and Bharat Biotech have signed a binding letter of intent (LOI) to co-develop India’s COVID-19 vaccine candidate Covaxin for the United States market.
The decision comes amid the ongoing Phase III clinical trials for Covaxin in India and the “promising safety and immunogenicity data” that emerged from the Phase I and Phase II.
The companies have begun collaborating and will finalise details of the definitive agreement in the next few weeks, they said in a joint statement on Tuesday.
Ocugen will get U.S. rights to the vaccine candidate and with Bharat Biotech, it will be responsible for clinical development, registration and commercialisation for the U.S. market. The collaboration seeks to leverage Ocugen’s vaccine expertise as well as its research and development capabilities and regulatory compliance rigour in the U.S. Earlier in the day, Bharat Biotech, which is developing Covaxin with Indian Co
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