According to the agreement, Ocugen will have the commercial rights to administer vaccines to candidates in the United States and will be responsible to conduct clinical trials and acquire emergency use authorization from the United States Food and Drug Administration.
On Thursday, Bharat Biotech International Ltd announced that it has signed an agreement with US-based biopharmaceutical company Ocugen to co-develop, supply, and commercialize its Covid-19 vaccine Covaxin in the United States.
Under the terms of the signed pact, Ocugen will have the commercial rights to administer vaccines to candidates in the United States and will be responsible to conduct clinical trials and acquire regulatory approval including emergency use authorization (EUA) from the United States Food and Drug Administration (US FDA). After receiving EUA, Ocugen can commercialize the vaccine in the US market, and keep 45% of the profits that are made and the rest goes to Bharat Biotech.
Bharat Biotech will provide the initial vaccine doses to be used in the United States upon the receipt of EUA. It will also help Ocugen with the technology transfer for manufacturing the vaccine in the United States.
Ocugen’s management and vaccine scientific advisory board have started holding discussions with the US FDA and the Biomedical Advanced Research and Development Authority (BARDA) to secure EUA and then receive a biologics license application approval for Covaxin in the United States. Ocugen is also having discussions with manufacturers in the United States in order to produce a large number of doses of Covaxin to support the nation’s immunization program.
Bharat Biotech Chairman and Managing Director Krishna Ella said: “With the recent progression of Covaxin use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring Covaxin to the US market.”
Covaxin was approved by the Drugs Controller General of India last month, following which administration of it started on January 16.