Bharat Biotech and Ocugen To Co-Develop COVAXIN For U.S. Market

US-based biopharmaceutical firm Ocugen Inc and Bharat Biotech on Tuesday announced that they will co-develop the latter's COVID-19 vaccine candidate, COVAXIN, for the United States' market. They have signed a binding letter of intent to co-develop the vaccine. It is currently undergoing Phase 3 clinical trials in India.

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Bharat Biotech and Ocugen join hands to develop COVAXIN

"We are delighted to collaborate with Bharat Biotech to potentially bring Covaxin to the US 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. We have been very pleased with the safety and immunogenicity demonstrated by the Phase 1 and Phase 2 trials of Covaxin and are encouraged with the progress of the Phase 3 trials in India," said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.

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'Will finalize details of the agreement in a few weeks'

The two companies (Ocugen Inc and Bharat Biotech) said in a joint statement that they have begun collaborating and will finalize details of the definitive agreement in the next few weeks. This collaboration leverages Ocugen's vaccine expertise, and its R&D and regulatory capabilities in the US. As per the letter of intent (LOI), "Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialization for the US market."

They also mention in their statement that in preparation for the development of Covaxin in the United States, 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.

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'We are excited to collaborate with Ocugen'

"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 US market," Bharat Biotech Chairman and MD Krishna Ella said.

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(With Agency Inputs)