Intellipharmaceutics Announces First Quarter 2019 Results.

ENPNewswire-April 16, 2019--Intellipharmaceutics Announces First Quarter 2019 Results

(C)2019 ENPublishing - http://www.enpublishing.co.uk

Release date- 15042019 - TORONTO - Intellipharmaceutics International Inc. (OTCQB: IPCIF and 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 three months ended February 28, 2019.

All dollar amounts referenced herein are in United States dollars unless otherwise noted.

Corporate Developments

On April 12, 2019, we and Mallinckrodt LLC ('Mallinckrodt') mutually agreed to terminate our license and commercial supply agreement effective no later than August 31, 2019. Under the terms of our mutual agreement, Mallinckrodt has been released from certain obligations under the license and commercial supply agreement as of April 12, 2019. The Company is in discussions with other parties who are interested in marketing and distributing our products which have been licensed under the agreement.

In March 2019, we announced that the United States Food and Drug Administration ('FDA') acknowledged receipt of our resubmission of the abuse-deterrent oxycodone hydrochloride extended release formulation ('Oxycodone ER') New Drug Application ('NDA') filed on February 28, 2019. The FDA informed us that it considers the resubmission a complete response to the September 22, 2017 action letter it issued in respect of the NDA. The FDA also assigned a Prescription Drug User Fee Act ('PDUFA') goal date of August 28, 2019.

In March 2019, the Nasdaq Hearings Panel determined to delist our shares from Nasdaq based upon our non-compliance with the $1.00 minimum bid price requirement, as set forth in Nasdaq Listing Rule 5550(a)(2). The suspension of trading on Nasdaq took effect at the open of business on March 21, 2019. Our shares began trading on OTCQB Venture Market ('OTCQB'), which is operated by the OTC Markets Group Inc., commencing on March 21, 2019. Our shares also are listed on the TSX under the symbol 'IPCI'and our non-compliance with Nasdaq's requirements did not impact our listing or trading status on thatexchange.

On February 21, 2019, we and our CEO, Dr. Isa Odidi ('Defendants'), were served with a Statement of Claim filed in the Superior Court of Justice of Ontario ('Court') for a proposed class action under the Ontario Class Proceedings Act ('Action'). The Action was brought by Victor Romita, the proposed representative plaintiff ('Plaintiff'), on behalf of a class of Canadian persons ('Class') who traded shares of the Company during the period from February 29, 2016 to July 26, 2017 ('Period'). The Statement of Claim, under the caption Victor Romita v. Intellipharmaceutics International Inc. and Isa Odidi, asserts that the Defendants knowingly or negligently made certain public statements during the Period that contained or omitted material facts concerning Oxycodone ER abuse-deterrent oxycodone hydrochloride extended release tablets. The Plaintiff alleges that he and the Class suffered loss and damages as a result of their trading in the Company's shares during the Period. The Plaintiff seeks, among other remedies, unspecified damages, legal fees and court and other costs as the Court may permit. On February 26, 2019, the Plaintiff delivered a Notice of Motion seeking the required approval from the Court, in accordance with procedure under the Ontario Securities Act, to allow the statutory claims under the Ontario Securities Act to proceed with respect to the claims based upon the acquisition or disposition of the Company's shares on the Toronto Stock Exchange ('TSX') during the Period. No date has been set for the hearing of the Notice of Motion. No date has been set for the hearing of the certification application. The Defendants intend to vigorously defend the action and have filed a Notice of Intent to Defend.

In February 2019, we received tentative approval from the FDA for our Abbreviated New Drug Application ('ANDA') 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 commenced a research and development ('R&D') program of pharmaceutical cannabidiol ('CBD') based products. As part of this R&D 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, or DEL, and a dealer's license under the...

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