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Bharat Biotech initiates steps for developing Covaxin for US markets, signs LOI with Ocugen

A Raju, Hyderabad
Saturday, December 26, 2020, 08:00 Hrs  [IST]

The Hyderabad-based Bharat Biotech has started initiating steps for manufacturing Covaxin COVID-19 vaccine for US markets. As part of this, the company has recently signed a binding letter of intent (LOI) with US based Ocugen Inc to co-develop the vaccine.

According to the company, as per the agreement, Ocugen will be responsible for clinical development, registration and commercialization of the Covaxin vaccine in the US markets.

While revealing about the company’s plans, Suchitra Ella, joint managing director of Bharat Biotech said that they have already enrolled more than 13,000 volunteers as part of their first level of third phase clinical trials and successfully administered two doses of vaccine for them and all have shown remarkable results with no side effects.

Having achieved positive results during the first part of phase-3 clinical trials for Covaxin, the company has now embarked on enrolling the remaining subjects and has already registered more than 13,000 more volunteers for the second part of phase-3 clinical trials, which is very soon going to be concluded by end of January, 2021.

In the meantime, the lead Indian biotechnology manufacturer is also taking steps to manufacture, distribute and market the vaccine in western countries like USA and Europe. As part of this, the company has signed a letter of intent with Ocugen Inc, which will co-develop the vaccine with Bharat Biotech for the US and other western markets.

As per the agreement between Ocugen and Bharat Biotech, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialization for the US market.

In the coming days, both the companies will further collaborate and will finalize details of the definitive agreement.

 

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