Biovail's patent infringement lawsuit against Cary Pharma may affect IntelGenx revenues

Aug 24 2009

IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") previously announced that the New Drug Application (NDA) filing for the antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma") had been accepted by the U.S. Food and Drug Administration (FDA) for standard review. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL^®. As required in connection with the filing of the NDA, IntelGenx's development partner Cary Pharma, which serves as the NDA applicant, provided notice of the NDA filing to Biovail Laboratories SLR (Biovail) which holds the patent for Wellbutrin XL. In such notice, Cary Pharma contended that CPI-300 would not infringe Biovail's patents. On August 18, 2009, IntelGenx learned that Cary Pharma was named in a lawsuit filed by Biovail in the U.S. District Court for the District of Delaware for patent infringement under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984, known as the "Hatch-Waxman Act," with respect to Biovail's U.S. Patent No. 6,096,341. Pursuant to the Hatch-Waxman Act, the filing of the patent infringement lawsuit against Cary Pharma by Biovail instituted an automatic stay of any FDA approval of the NDA until the earlier of a judgment or January 3, 2012. The Biovail lawsuit seeks to prevent the manufacture or sale of CPI-300 during the life of the Biovail patent. Although IntelGenx is not a party to the action, any decision could have an effect on IntelGenx's potential revenues relating to CPI-300. Cary Pharma and IntelGenx believe that CPI-300 does not infringe Biovail's patent and will vigorously assert their rights.

"Since litigation is often part of the Hatch-Waxman process, Biovail's lawsuit did not take us by surprise and we are prepared for it" said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We have a strong position for a favorable resolution and will vigorously pursue such an outcome. We remain very excited about the potential for CPI-300".

IntelGenx and Cary Pharma entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral delivery technology.

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