Pomerantz LLP announces that a class action lawsuit has been filed against IntelliPharmaCeutics International Inc. (“IntelliPharma” or the “Company”) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 17-cv-06045, is on behalf of a class consisting of investors who purchased or otherwise acquired IntelliPharma securities, seeking to recover compensable damages caused by defendants’ violations of the Securities Exchange Act of 1934.
IntelliPharma is a pharmaceutical company specializing in research, development, and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s main product candidate is Rexista, an abuse-deterrent oxycodone hydrochloride extended release tablets. Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) IntelliPharma failed to conduct a human abuse liability study to support its Rexista New Drug Application (“NDA”); (ii) the Company did not include abuse-deterrent studies conducted to support abuse-deterrent label claims related to abuse of the drug by various pathways, including oral, intra-nasal and intravenous routes of abuse; (iii) IntelliPharma was not submitting sufficient data to support approval of the Rexista NDA; and (iv) as a result of the foregoing, IntelliPharma’s public statements were materially false and misleading at all relevant times.
On July 27, 2017, before the market opened, IntelliPharma issued a press release announcing an update on the U.S. Food and Drug Administration (“FDA”) Advisory Committee Meeting for Rexista (“July 2017 Press Release”). The press release stated, in relevant part, that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee “voted 22 to 1 in finding that the Company’s [NDA] for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time. The committees also voted 19 to 4 that the Company has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration, and 23 to 0 that there are not sufficient data for Rexista to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.”
On this news, IntelliPharma’s share price fell $1.13, or 45.38%, to close at $1.36 on July 27, 2017.