Hyderabad (Telangana) [India], December 22 (ANI): Hyderabad-based Bharat Biotech and US-based biopharmaceutical firm Ocugen Inc on Tuesday announced that they have signed a binding letter of intent (LOI) to co-develop the Indian firm's COVID-19 vaccine candidate--Covaxin-- for the United States market.
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 commercialisation for the US market."
In a joint statement, the companies said that they 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."
"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.
"We believe this unique yet traditional approach to vaccination holds great potential to appeal to a broad range of the population," he added.
According to the statement, in preparation for the development of Covaxin in the US, 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.
"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.
The statement said that Covaxin has been evaluated in approximately 1,000 subjects in Phase 1 and Phase 2 clinical trials in India, with promising safety and immunogenicity data. The vaccine candidate is currently part of a Phase 3 clinical trial in India involving 26,000 volunteers. (ANI)