kei, on IPCI's approval...correction below (I still enjoy your style)
Intellipharmaceutics Announces Approval of Settlement Related to ADHD Drug Focalin XR(R)
TORONTO, May 6, 2010 (GlobeNewswire via COMTEX) -- Intellipharmaceutics International Inc. /quotes/comstock/15*!ipci/quotes/nls/ipci (IPCI 2.80, +0.46, +19.86%) /quotes/comstock/11t!e:i (CA:I 2.50, -0.37, -12.89%) and its wholly owned subsidiary Intellipharmaceutics Corp. (collectively "Intellipharmaceutics" or the "Company") today announced that it and its licensee and development partner Par Pharmaceutical, Inc. ("Par") have received confirmation that the previously announced stays of the patent litigation concerning a generic version of Novartis' Attention Deficit Hyperactivity Disorder drug, Focalin XR(R), (dexmethylphenidate hydrochloride), have expired without regulatory intervention, and that the parties have stipulated to a dismissal of the litigation.
The parties, Intellipharmaceutics, Par, Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Celgene Corporation, Elan Corporation, PLC and Elan Pharma International Ltd., have also entered into license agreements in conjunction with the settlements of the litigation concerning the Company's generic drug application in the FDA for 5, 10, 15 and 20 mg strengths of dexmethylphenidate hydrochloride. Pursuant to the license agreements, Intellipharmaceutics and Par are granted fully paid up, royalty-free, non-exclusive licenses under the relevant patents pertaining to Focalin XR(R). These licenses will permit Par to market, offer for sale, sell or take orders in the U.S. starting in October 2012 (or earlier in limited circumstances) for any of the Company's 5, 10, 15, and 20 mg strengths of dexmethylphenidate hydrochloride XR capsules that have received final FDA approval. The Company has a ten year profit-sharing agreement with Par for the sale of dexmethylphenidate hydrochloride XR capsules in the U.S., which commences with the commercial launch of the product by Par. Additional details of the license agreement remain confidential.
"We are extremely pleased about the filing of the stipulations of dismissal of the litigation involving our lead ANDA product, a generic version of the controlled-release drug Focalin XR.," commented Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "This action is an important step in bringing the first of the 15 products in our pipeline to market."
In 2008, Focalin(R), including Focalin XR(R), had U.S. sales of approximately U.S. $350 million. Intellipharmaceutics' application for approval of a generic version of Focalin XR(R) remains subject to FDA approval. No assurance can be given as to whether or when the FDA will approve Intellipharmaceutics' generic version of Focalin XR(R).
