Intellipharmaceutics Announces Approval Of Settlement Related To ADHD Drug Focalin XR(R)
TORONTO, May 6, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) 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®, (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®. 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."
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV