Covid-19: Ocugen to Seek Emergency Clearance for Health Canada’s Covaxin | India News

Covid-19: Ocugen to Seek Emergency Clearance for Health Canada's Covaxin |  India News

HYDERABAD: Bharat BiotechUS partner Ocugen said it will seek an emergency use go-ahead for the first Covid-19 vaccine developed in India. Covaxin from the Canadian health authorities. The company said it has already started talks with Health Canada to seek regulatory approval.
“The company will seek expedited authorization for Covaxin under the interim order regarding the import, sale, and advertising of drugs for use in connection with Covid-19 in Canada,” Ocugen said in a regulatory filing with the Securities and Exchange Commission ( SEC).
Ocugen had recently acquired the rights to Covaxin for the Canadian market also from Bharat Biotech and last week said it had made a $ 15 million upfront payment to the Indian vaccine manufacturer for the Canadian rights to the vaccine.
In addition to the initial non-refundable payment, Ocugen will also make a historic payment of $ 10 million to Bharat Biotech within 30 days of Covaxin’s first commercial sale in Canada.
Earlier this month, Bharat Biotech and Ocugen had announced that they had modified the exclusive agreement previously signed for the US market to also include the Canadian market.
Like the agreement for the US market, in addition to the advance payment and the milestone payment on the first commercial sale, Ocugen would retain 45% of the profits from Covaxin sales in Canada, while Bharat Biotech would get 55% of earnings.
“In clinical trials to date, the emerging safety profile of Covaxin supports that it is generally well tolerated with a good safety profile, and the Ministry of Health and Family Welfare of the Republic of India did not report potential thromboembolic events. after the administration of more than 6.7 million doses of Covaxin in that country, ”said Dr. Bruce Forrest, acting medical director and member of Ocugen’s Vaccine Scientific Advisory Board.


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