Hyderabad: The US-based biopharmaceutical company Ocugen and Hyderabad-based Bharat Biotech have signed a binding letter of intent (LOI) to co-develop the latter’s Covid-19 vaccine candidate, Covaxin, an advanced stage whole-virion inactivated vaccine candidate, for the United States market.
As 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.
In preparation for the development of Covaxin in the US, Ocugen has assembled a Vaccine Scientific Advisory Board featuring academic and industry experts to evaluate the clinical and regulatory path to approval in the US market.
“Covaxin offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus,” said Harvey Rubin, a member of Ocugen’s Vaccine Scientific Advisory Board.
“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,” said Dr Shankar Musunuri, chairman, CEO, and co-founder of 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,” said Dr Krishna Ella, CMD of Bharat Biotech.