November 20, 2014

Intellipharmaceutics Notes Launch of 5mg Strength of Focalin XR(R) Generic by Teva

TORONTO, Nov. 20, 2014 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("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, based on information regarding recent generic introductions by Teva Pharmaceuticals ("Teva") on its website (http://www.tevagenerics.com/products/new-teva-generics), it believes that Teva has launched a generic version of the 5mg strength of its dexmethylphenidate hydrochloride generic of Focalin XR®, although the exact launch date by Teva is not known by the Company.

As previously announced, the Company had received a conditional approval from the U.S. Food and Drug Administration ("FDA") on November 18, 2013 to launch its own generic version of 5mg Focalin XR®. It is understood by the Company that the conditional approval could be made final upon the expiry of six months from the date of marketplace launch in the United States by the company first to file for approval of the 5mg strength with the FDA. The Company believes that Teva is the company with that first-to-file exclusivity status.

If the Company receives a final approval to launch its generic version of the 5mg strength of Focalin XR® six months after the date of launch of the 5mg strength by Teva, the Company believes that its manufacturing, marketing and distribution partner for Focalin XR® generics in the United States, Par Pharmaceutical ("Par"), intends to launch this strength immediately upon the expiry of the exclusivity period, but there can be no assurance as to when or if any launch will occur.  

The Company is unable to predict or estimate, in respect of its generic of 5mg Focalin XR®, a date of final FDA approval; an actual launch date, if any, by Par; the number of competitors then approved by the FDA to launch competing 5mg  generic products; any actual market penetration or market share; the market pricing or discounts which might then be in effect; or the amount and timing of revenues, if any, to which the Company may then be entitled under its distribution agreement with Par.

The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, "We are very pleased, after waiting almost exactly one year since Teva received final approval, that Teva now appears to have launched its 5mg Focalin XR® generic in the United States. Par now manufactures, markets and distributes the 15mg and 30mg strengths of generic Focalin XR®, and we would be pleased to see the 5mg strength added to their portfolio."

About Intellipharmaceutics

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 the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths) and product candidates in various stages of development, including Abbreviated New Drug Applications filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista™ oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical Overdose Resistance Activating System, and Regabatin™ XR pregabalin extended-release capsules.

Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," "intends," "could," or the negative of such terms or other comparable terminology. 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Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers' facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Company Contact:

         Intellipharmaceutics International Inc.

         Dr. Isa Odidi

         CEO and co-Chief Scientific Officer

         416-798-3001

         investors@intellipharmaceutics.com

         

         Investor Contact:

         ProActive Capital

         Kirin Smith

         646-863-6519

         ksmith@proactivecapital.com


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