Bharat Biotech, Ocugen To Co-Develop Covaxin For U.S. Market

Bharat Biotech and U.S.-based biopharmaceutical firm Ocugen Inc on Tuesday said they have signed a binding letter of intent to co-develop the Indian firm’s Covid-19 vaccine candidate Covaxin for the U.S. market.

As per the letter of intent, “Ocugen will have U.S. rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialisation for the U.S. market”.

The companies in a joint statement said they have begun collaborating and will finalise details of the definitive agreement in the next few weeks.

The collaboration leverages Ocugen’s vaccine expertise, and its research and development and regulatory capabilities in the U.S., the statement added.

“We are delighted to collaborate with Bharat Biotech to potentially bring Covaxin to the U.S. market. In the face of the coronavirus pandemic, it is incumbent upon all of us to find solutions that have the potential to save lives and restore normalcy to our day-to-day activities,” Ocugen Chairman, Chief Executive and Co-Founder Shankar Musunuri said.

“We have been very pleased with the safety and immunogenicity demonstrated by the Phase 1 and Phase 2 trials of Covaxi and are encouraged with the progress of the Phase 3 trials in India,” he added.

In preparation for the development of Covaxin in the U.S., Ocugen has assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the U.S. market, the statement said.

“The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India. Covaxin has garnered interest from several countries worldwide for supplies and introduction and we are excited to collaborate with Ocugen to bring it to the U.S. market,” Bharat Biotech Chairman and Managing Director Krishna Ella said.