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A class-action lawsuit has been initiated against Ocugen Inc., Bharat Biotech’s partner for Covaxin in the US and Canada, for alleged `false and misleading’ statements about its business.
The US-based law firm Pomerantz had filed the suit in the US District Court for the Eastern District of Pennsylvania on behalf of persons and entities other than Ocugen that purchased or otherwise acquired Ocugen securities between February 2, 2021, and June 10, 2021.
On February 2, Ocugen announced an exclusive licensing agreement with Hyderabad-based Bharat Biotech to obtain exclusive rights to develop, manufacture and commercialise the latter's Covid-19 vaccine, Covaxin, in the US. Later, the scope of the agreement was expanded to cover Canada as well.
Pomerantz alleges that Ocugen “failed to disclose that the information submitted to the (US)FDA was insufficient to support an EUA, Ocugen would not file an Emergency Use Authorization with the FDA, (and) as a result of the foregoing, the Company's financial statements, as well as defendants' statements about Ocugen's business, operations, and prospects, were false and misleading or lacked a reasonable basis,"
However, its efforts to get the India-made Covaxin approved by the US had many twists and turns. While initially, applied for Emergency Use Authorisation (EUA), it later said the US FDA had directed the company to apply for a full biological license.
Ocugen is yet to make a formal announcement on the development.
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