Ocugen Inc, the US partner for India's Bharat Biotech Covid-19 vaccine Covaxin said that it will pursue emergency-use approval of the vaccine in Canada. On June 3, the biopharmaceutical company announced that it has secured exclusive rights to commercialise Covaxin in Canada. The company also said that it has begun discussions with Health Canada for regulatory approval, reported PTI.
"The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 in Canada," PTI reported the company as saying.
Also read: Bharat Biotech's Covaxin not getting US nod won't impact India, clarifies Govt
Ocugen said that for the amendment to expand its rights to commercialize Covaxin in Canada it will make an upfront payment of $15 million to the Indian drugmaker. In a regulatory filing, the company said it has agreed to pay another $10 million to Bharat Biotech within a month from the commercial launch of the vaccine in the country.
"As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe Covaxin has the potential to play a key role in saving lives from Covid-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” Dr Shankar Musunuri, chairman of the board, chief executive officer, and co-founder of Ocugen said.
{{/usCountry}}"As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe Covaxin has the potential to play a key role in saving lives from Covid-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” Dr Shankar Musunuri, chairman of the board, chief executive officer, and co-founder of Ocugen said.
{{/usCountry}}Ocugen also said that following the same pattern of the US profit sharing agreement, the company will retain 45 per cent of the profits from the sales of Covvaxin in Canada.
Meanwhile, the company on Friday saw a major setback that delayed the vaccine launch in the US. The Food and Drug Administration (FDA) recommended Oucgen to go for the Biologics Licence Application (BLA) route with additional data, shadowing the hopes of emergency use approval.