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Bharat Biotech and US-based biopharmaceutical agency Ocugen Inc on Tuesday stated they’ve signed a binding letter of intent to co-develop the Indian agency’s COVID-19 vaccine candidate Covaxin for the US 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 corporations in a joint assertion stated they’ve begun collaborating and can finalise particulars of the definitive settlement within the subsequent few weeks. The collaboration leverages Ocugen’s vaccine experience, and its R&D and regulatory capabilities within the US, the assertion 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 stated.
“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 event of Covaxin within the US, Ocugen has assembled a Vaccine Scientific Advisory Board that includes main tutorial and business specialists to consider the medical and regulatory path to approval within the US market, the assertion stated.
“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 stated.
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