TORONTO, ON / ACCESSWIRE / February 20, 2019 / Intellipharmaceutics International Inc. (NASDAQ 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 announced that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the Company's abbreviated new drug application ("ANDA") for desvenlafaxine extended-release tablets in the 50 and 100 mg strengths. The approved product is a generic equivalent of the branded product Pristiq® sold in the U.S. by Wyeth Pharmaceuticals, LLC ("Wyeth").
Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor ("SNRI") indicated for the treatment of major depressive disorder ("MDD"). The Company previously announced that it had entered into a license and commercial supply agreement with Mallinckrodt LLC ("Mallinckrodt"), which granted Mallinckrodt, subject to its terms, an exclusive license to market, sell and distribute in the U.S. the Company's desvenlafaxine extended-release tablets (generic Pristiq®). Among other things, the agreement provides for the Company to have a long-term profit sharing arrangement with respect to the licensed product. Intellipharmaceutics has agreed to manufacture and supply the licensed product exclusively for Mallinckrodt on a cost-plus basis, and Mallinckrodt has agreed that Intellipharmaceutics will be its sole supplier of the licensed product marketed in the U.S.
Dr. Isa Odidi, CEO of Intellipharmaceutics, stated, "We are quite happy the FDA has granted tentative approval of our generic version of Pristiq®. We believe the achievement of this milestone demonstrates Intellipharmaceutics' ability to successfully take product candidates from development to regulatory approval and speaks to the inherent potential of our product pipeline."
According to Symphony Health Solutions Corporation, sales in the United States for the 12 months ended January 2019 of Pristiq® and all generic equivalents, were approximately $279 Million (in TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price).
The Company is aware that several other generic versions of this product are currently available that serve to limit the overall market opportunity for this product. There can be no assurance that the Company's desvenlafaxine extended-release tablets in the 50 or 100 mg strengths will receive final FDA approval or, if approved, that they will be successfully commercialized and produce significant revenue for us.
For more information regarding the Company's agreement with Mallinckrodt, see the Company's filings with the Securities and Exchange Commission.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and new drug application ("NDA") 505(b)(2) drug product candidates in its development pipeline. These include the Company's abuse-deterrent oxycodone hydrochloride extended release formulation ("Oxycodone ER") based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules).