Ocugen to commercialise Covaxin in Mexico, working on US market too

Covaxin has EUA in Mexico for use in adults; data submitted for EUA for children aged 2-18 years

Nasdaq-listed biotechnology firm Ocugen Inc will now commercialise Covaxin in Mexico. The firm is already a partner of Hyderabad-based Bharat Biotech for commercialising the Covid19 vaccine in the US territory.

Bharat Biotech today said that it has entered into an amendment to its co-development, supply and commercialisation agreement to expand Ocugen's exclusive territory to include commercialisation of Covaxin in Mexico. This gives Ocugen the commercialisation rights for all of North America for the formulation.

“We’re excited about commercialising Covaxin in Mexico, as authorities there have made conquering this pandemic a major priority. After meeting with Mexico’s Secretary of Foreign Affairs, Marcelo Ebrard, in Delhi, we are encouraged by the role Covaxin can play in Mexico’s continuing efforts to defeat the Covid-19 pandemic. Covaxin is currently under review by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age, and Ocugen is prepared to collaborate with the public health community to help their efforts. We also thank Bharat Biotech for helping make this opportunity a reality,” said Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-founder of Ocugen, Inc.

Covaxin already has an emergency use approval (EUA) for use in adults in Mexico, and is now under review of the Mexican regulator for use in children aged between 2 and 18 years.

“We are delighted to announce our partnership with Ocugen for Mexico, along with the United States and Canada. Covaxin is a safe and efficacious inactivated vaccine for all age groups as evident from its data from global introduction. We are fully supportive of team Ocugen in our endeavor to expedite technology transfer activities towards commercial scale manufacturing of Covaxin in North America,” said Krishna Ella, Chairman and Managing Director, Bharat Biotech.  

The license extension between Ocugen and Bharat Biotech with respect to commercialisation in Mexico includes the same profit share structure as in the United States.