Covid-19: Ocugen to seek emergency nod for Covaxin from Health Canada | India News

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HYDERABAD: Bharat Biotech’s US partner Ocugen said it will be seeking an emergency use nod for India’s first indigenously developed Covid-19 vaccine Covaxin from the Canadian health authorities. The company said it has already initiated discussions with Health Canada to seek regulatory approval.
“The company will pursue expedited authorisation for Covaxin under the interim order respecting the importation, sale and advertising of drugs for use in relation to Covid-19 in Canada,” Ocugen said in a regulatory filing to the Securities & Exchange Commission (SEC).
Ocugen had recently acquired the Covaxin rights for the Canadian market as well from Bharat Biotech and last week said it had made an upfront payment of $15 million to the Indian vaccine maker for the Canadian rights of the vaccine.
Apart from the non-refundable upfront payment, Ocugen will also be making a milestone payment of $10 million to Bharat Biotech within 30 days of the first commercial sale of Covaxin in Canada.
Earlier this month, Bharat Biotech and Ocugen had announced that they had amended the exclusive agreement inked earlier for the US market to include the Canadian market as well.
Just like the deal for the US market, apart from the upfront payment and milestone payment upon first commercial sale, Ocugen would be retaining 45% of the profits from Covaxin sales in Canada, while Bharat Biotech would get 55% share of the profits.
“In clinical trials to date, the emerging safety profile of Covaxin is supportive of it being generally well tolerated with a good safety profile, with the Ministry of Health and Family Welfare of Republic of India reporting no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin in that country,” said Dr Bruce Forrest, acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.



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