– FDA Issues Final Approval of 15 mg, With 180 Canicule of Exclusivity, and 30 mg; and
– Tentative Approvals for the Company’s 5, 10, 20 and 40 mg Strengths
TORONTO, Nov. 18, 2013 (GLOBE NEWSWIRE) — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) (“Intellipharmaceutics” or the “Company”) a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled-release and targeted-release articulate solid dosage drugs today appear that the U.S. Food and Biologic Administration (“FDA”) has accepted final approval of the Company’s dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. Commercial auction of these strengths will be launched anon by the Company’s commercialization accomplice in the United States Par Pharmaceutical, Inc. (“Par”).
As the first-filer for the biologic artefact in the 15 mg strength, the Aggregation will accept 180 canicule of exclusivity of all-encompassing sales from the date of barrage in the United States by its partner, Par.
The Company’s 5, 10, 20 and 40 mg strengths were additionally tentatively FDA approved, accountable to the appropriate of addition affair or parties to 180 canicule of all-encompassing exclusivity from the date of aboriginal barrage by such parties. Par intends to barrage these strengths anon aloft the accomplishment of those exclusivity periods.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, “FDA approval of our appliance for a all-encompassing adaptation of Focalin XR® is a above anniversary for the Aggregation in several respects. We accept that the approval represents a able validation of our bulk biologic development adequacy and our controlled-release commitment technologies. At the aforementioned time, we accept approved that we can accomplice with an accustomed and well-regarded biologic company, in this case Par Pharmaceutical, to see a artefact through to commercialization in the United States. Finally, this all-encompassing artefact will accomplish our aboriginal revenues from bartering sales of a biologic artefact in the United States and accommodate an added akin of banking adaptability to the Company.”
Focalin XR®, a biologic acclimated in the analysis of absorption arrears hyperactivity disorder, is marketed by Novartis Pharmaceuticals Corporation. According to Source Healthcare Analytics, sales for the 12 months concluded October 2013 of Focalin XR® 15 and 30 mg, respectively, in the U.S. were about $136 actor and $69 actor (TRx MBS Dollars, which represents projected new and refilled prescriptions apery a connected dollar metric based on manufacturer’s appear archive or account prices to wholesalers, and does not represent absolute transaction prices and does not accommodate alert pay or added discounts, rebates or reductions in price). The absolute 5, 10, 20, 25, 35 and 40 mg strengths represent sales of about $478 actor (TRx MBS Dollars).
Intellipharmaceutics International Inc. is a biologic aggregation specializing in the research, development and accomplish of atypical and all-encompassing controlled-release and targeted-release articulate solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release biologic commitment belvedere that can be activated to the able development of a advanced ambit of absolute and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several biologic commitment systems and a activity of artefact candidates in assorted stages of development, including Abbreviated New Biologic Applications (“ANDAs”) filed with the FDA in ameliorative areas that accommodate neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics additionally has New Biologic Appliance 505(b)(2) artefact candidates in its development pipeline. These accommodate Rexista™ oxycodone, an abuse-deterrent oxycodone, based on its proprietary atypical Point Of Divergence Biologic Commitment System (“nPODDDS™”) and a pregabalin extended-release (“Regabatin™ XR”).
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