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Biopharmaceutical company Ocugen Inc and Bharat Biotech have signed a binding letter of intent (LOI) to co-develop the latter’s Covid-19 vaccine candidate Covaxin for the US market.
Covaxin is in an advanced stage whole-viron inactivated vaccine candidate. It has been evaluated in approximately 1,000 subjects in Phase-I and Phase-II clinical trials in India, with promising safety and immunogenicity data. The vaccine candidate is currently part of a Phase-III clinical trial in India involving 26,000 volunteers.
Per the LOI, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialisation for the US market.
The companies have begun collaborating and will finalise 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.
In preparation, 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 US market.
“We are delighted to collaborate with Bharat Biotech to potentially bring Covaxin to the US market. We have been very pleased with the safety and immunogenicity demonstrated by the Phase-I and Phase-II trials of COVAXIN™ and are encouraged with the progress of the Phase-III trials in India,’’ Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen said in a release issued on Tuesday.
“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,” Krishna Ella, Chairman & Managing Director of Bharat Biotech, said.
Covaxin utilises a historically proven approach to vaccine design. The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike (S1) protein, receptor-binding domain (RBD) and the nucleocapsid (N) protein of SARS-CoV2
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