NEW DELHI:Bharat Biotechand US-based biopharmaceutical firmOcugen Incon Tuesday said they have signed a binding letter of intent to co-develop the Indian firm’sCOVID-19 vaccinecandidateCovaxinfor theUS 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.”
The companies in a joint statement said they have begun collaborating and will finalise details of the definitive agreement in the next few weeks.
The collaboration leverages Ocugen’s vaccine expertise, and its R&D and regulatory capabilities in the US, the statement added.
“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,” Ocugen Chairman, CEO and co-founder Shankar Musunuri said.
“We have been very pleased with the safety and immunogenicity demonstrated by the Phase 1 and Phase 2 trials of Covaxi and are encouraged with the progress of the Phase 3 trials in India,” he added.
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 statement said.
“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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