Ocugen Chairman and CEO Shankar Musunuri
By John George – Senior Reporter, Philadelphia Business Journal
A Chester County company working to bring the Covid-19 vaccine Covaxin to the United States has entered into a deal to buy a dormant manufacturing plant in Canada.
Ocugen Inc. (NASDAQ: OCGN) of Malvern said Thursday it has signed a non-binding letter of intent with Liminal BioSciences Inc. to acquire its manufacturing site in Belleville, Ontario, for an undisclosed amount.
This site, Ocugen said, would enable it to expand manufacturing and research and development activities to support its pipeline — which includes making Covaxin, as well as gene therapy candidates targeting retinal diseases.
Covaxin was developed by Bharat Biotech of India and is already approved for use overseas. Ocugen and Bharat entered into a partnership last year to bring the vaccine to North America and share revenues. Ocugen, through its Canadian affiliate Vaccigen Ltd., has submitted an application for Covaxin with Health Canada for regulatory review.
Last summer, the Food and Drug Administration advised Ocugen it would need to pursue a biologics license application to obtain full approval for Covaxin in the United States. In November, Ocugen filed an application with the FDA for emergency use authorization of Covaxin in children.
More than 200 million doses of Covaxin have been administered to adults and children outside the United States. The vaccine is authorized for emergency use in more than 20 countries; emergency use authorization applications are under review in more than 60 other countries.
“We believe establishing a manufacturing and R&D hub for our biotechnology platform is the right investment and next evolution of our business," said Dr. Shankar Musunuri, CEO and co-founder of Ocugen. "This site, after transformation into a state-of-the-art hub, with the support of the regional talent pool can help bring our products – from vaccines to our modifier gene therapy assets – to the patients we will serve globally.”
Alek Krstajic, Liminal BioSciences' board chairman, said his company was introduced to Ocugen by Innovation Science Economic Development Canada, a government agency.
“We are excited to see Ocugen’s plans to repurpose our dormant vaccine manufacturing facility and create vaccine manufacturing capacity in Canada," Krstajic said in a statement.
The completion of the deal is subject to the finalization of due diligence investigations by both companies, the negotiation and execution of definitive transaction agreements, and other customary closing conditions including certain undisclosed funding requirements.
Covaxin will be the first product manufactured in the new upgraded facility if the deal closes and the vaccine receives regulatory approval in Canada.
Ocugen's stock was trading down 3% at $3.05 per share in early afternoon trading on Thursday.
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