Intellipharmaceutics International Inc. (TSX & Nasdaq: IPCI, FRA: I4AA)
Ontario Superior Court of Justice, Court File No.: CV-19-00614686-00CP
This securities class action relates to the Defendants releasing core documents which contained untrue statements of material fact regarding Intellipharmaceutics International Inc. (“IPCI”):
- demonstrating bioequivalence of Rexista to Oxycontin and not having to undergo expensive Phase III human studies;
- including abuse-deterrent studies related to the abuse of Rexista by various pathways that IPCI conducted to support its abuse-deterrent label claims;
- submitting sufficient data to support approval of the Rexista New Drug Application (“NDA”); and
- completing the aforementioned studies and submitting the NDA as recommended in the FDA’s guidance released in April of 2015.
On July 26, 2017 after trading had closed for the day on the TSX, IPCI issued a press release announcing that the FDA had voted Rexista should not be approved for marketing while simultaneously omitting other material facts. The FDA released another statement adding that IPCI’s pharmacokinetic studies were of limited value because they were for single-dose studies, IPCI did not include human abuse liability studies submitted with the Rexista NDA, and that the FDA never approved an abuse-deterrent labeling for a product that did not have all three categories of studies (i.e. contradicting IPCI’s statement released on January 14, 2016, and subsequently reaffirmed within the impugned Class Period documents.
Upon the release of these public corrective statements, the price of IPCI’s common shares listed on the TSX dropped from $31.00 to $16.90 per share, or down 45.48%, in a single day on abnormally-high trading volume.