Hyderabad-headquartered Bharat Biotech has decided to develop Covaxin for the US market in collaboration with American biopharmaceutical firm Ocugen. The two companies have signed a binding letter of intent (LoI), Bharat Biotech said Tuesday.
According to the LoI, Ocugen will have the US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for “clinical development, registration, and commercialisation” of the candidate for that market.
“The companies 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,” said Bharat Biotech in its statement.
In preparation for the development of Covaxin in the US, Ocugen has assembled a ‘Vaccine Scientific Advisory Board’ to evaluate the clinical and regulatory path to approval in the US market.
“Vaccines such as Covaxin that can potentially elicit a broad immune response and may limit future Covid-19 severity could be important to have in our arsenal,” said David Fajgenbaum, a member of Ocugen’s Vaccine Scientific Advisory Board.
“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,” said Dr Krishna Ella, CMD, Bharat Biotech.
The vaccine has been evaluated in approximately 1,000 subjects in phase 1 and phase 2 clinical trials in India, and is currently part of a phase 3 clinical trial involving 26,000 volunteers.
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