The biopharmaceutical company stated that the dormant vaccine manufacturing site would add new capabilities to its medicine portfolio of Canadian and US companies.
It is expected to allow Ocugen to expand the manufacturing and research and development activities to support its pipeline that includes manufacturing the company’s Covid-19 vaccine candidate, Covaxin (BBV152).
Bharat Biotech has developed the vaccine candidate in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
It is a purified and inactivated vaccine that is produced using a vero cell manufacturing platform.
Ocugen’s Canadian affiliate Vaccigen has submitted an application for Covaxin to Health Canada for regulatory review.
If approved, Covaxin would become the first product to be manufactured at the upgraded Belleville facility.
According to the company, the facility will also have potential to manufacture breakthrough gene therapy candidates and will also serve as research and development (R&D) hub.
Ocugen chairman, CEO and co-founder Dr. Shankar Musunuri said: “We believe establishing a manufacturing and R&D hub for our biotechnology platform is the right investment and next evolution of our business.
“This site, after transformation into a state-of-the-art hub, with the support of the regional talent pool can help bring our innovative products – from vaccines to our modifier gene therapy assets – to the patients we will serve globally.”
The company stated that the deal completion is subject to due diligence investigations finalisation by both the companies, the negotiation and execution of definitive transaction deals, as well as other customary closing conditions that include certain funding requirements.
Covaxin is currently under review by the US Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age.