Intellipharmaceutics International Inc. (NASDAQ: IPCI, TSX: IPCI) (''Intellipharmaceutics'' or the ''Company''), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the year ended November 30, 2018. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
Fiscal 2018 highlights
''We believe our fiscal 2018 results are a positive reflection of our focus on our Oxycodone ER, Oxycodone IR and other 505(b)(2) development programs, despite financially challenging circumstances'' said Dr. Isa Odidi, CEO of Intellipharmaceutics. ''We continue to move forward with our existing development programs, manufacturing and commercial efforts while also considering new product candidates and markets.''
Corporate Developments
On February 21, 2019, the Company and its CEO, Dr. Isa Odidi, received a Statement of Claim concerning an action against them in the Superior Court of Justice of Ontario under the caption Victor Romita, plaintiff, and Intellipharmaceutics International Inc and Isa Odidi, defendants. The action seeks certification as a class action and alleges that certain public statements made by the Company in the period February 29, 2016 to July 26, 2017 knowingly or negligently contained or omitted material facts concerning the Company's New Drug Application (''NDA'') for Oxycodone ER abuse-deterrent oxycodone hydrochloride extended release tablets. The plaintiff alleges that he suffered loss and damages as a result of trading in the Company's shares on the Toronto Stock Exchange during the above-noted period. The claim seeks, among other remedies, unspecified damages, legal fees and court and other costs as the court may permit. At this time, the action has not been certified as a class action. The Company intends to vigorously defend against the claims asserted in this action.
In February 2019, we received tentative approval from the United States Food and Drug Administration (''FDA'') for our Abbreviated New Drug Applications (''ANDAs'') for desvenlafaxine extended-release tablets in the 50 and 100 mg strengths. This product is a generic equivalent of the branded product Pristiq® sold in the U.S. by Wyeth Pharmaceuticals, LLC.
In January 2019, we announced that we had received notice from the Nasdaq Hearings Panel (the ''Nasdaq Panel'') extending the continued listing of our common shares until March 7, 2019, subject to certain conditions, while we work to regain compliance with Nasdaq's requirements.
In January 2019, we announced that we had commenced a research and development program of pharmaceutical cannabidiol (''CBD'') based products. As part of this research and development program, we filed provisional patent applications with the United States Patent and Trademark Office pertaining to the delivery and application of cannabinoid-based therapeutics, began talks with potential commercialization partners in the cannabidiol industry, and identified a potential supplier of CBD. We hold a Health Canada Drug Establishment License (''DEL'') and a dealer's license under the Narcotics Control Regulations (''NCR''). Under the NCR license, we are currently authorized to possess, produce, sell and deliver drug products containing various controlled substances, including CBD, in Canada.
In November 2018, we announced that we had received final approval from the FDA for our ANDA for venlafaxine hydrochloride extended-release capsules in the 37.5, 75 and 150 mg strengths. The approved product is a generic equivalent of the branded product Effexor® XR sold in the U.S. by Wyeth Pharmaceuticals, LLC. We are actively exploring the best approach to maximize our commercial returns from this approval.
In November 2018, we announced that we had submitted an investigational new drug (''IND'') application to the FDA for our oxycodone hydrochloride immediate release (''IPCI006'') tablets in the 5, 10, 15, 20 and 30 mg strengths. This novel drug formulation incorporates our Paradoxical OverDo...
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