FDA Response to CPI-300’s NDA Anticipated Soon (NASDAQ:IGXT)

CPI-300 is a drug that has been developed by IntelGenx Corp. (NASDAQ:IGXT.OB) and its partner, Cary Pharmaceuticals, Inc, under the Collaborative Agreement signed by the two companies in 2007. The drug is used as an antidepressant with an increased strength and can be used to treat disorders associated with depression. According to IntelGenx, the drug has been developed using the “controlled release technology” (or oral delivery technology) that the company owns. The drug contains Bupropion HCL, which is the “active ingredient” of Welbutrin XL®. The latter has been discovered and patented by the Biovail Laboratories SLR. On April 7, 2009, Cary Pharmaceuticals filed the new drug application (NDA) to the United States of America’s Food & Drug Administration (FDA) to get the regulator’s approval to bring the CPI-300 into market. In addition, the company submitted a notice to Buovail Laboratories. In the notice, Cary provided reasons why the CPI-300 would not violate the patents held by Biovail. On June 23, the FDA found out that the NDA application was sufficiently complete that would allow it to make to thorough review – that is, the NDA was accepted for filing. The FDA also gave it a Precription Drug User Fee Act (PDUFA) date of February 6, 2009.

Everything was going well for both IntelGenx and Cary. However, on August 18, 2009, Biovail Laboratories filed a lawsuit against Cary for infringing its patent (U.S. Patent No. 6,096,341). The lawsuit was filed in the U.S. District Court for the District of Delaware under the Drug Price Competition and Patent Term Restoration Act – more commonly called the “Hatch-Waxman Act” – that was established in the year 1984. In the lawsuit, Biovail demanded the prevention of the manufacture and the sale of CPI-300 during the time the patient is active. Although the lawsuit was not filed against IntelGenx, it could affect the revenues of the company if it was successful in preventing the CPI-300 from being sold in the market.

Following the lawsuit, Dr. Horst G. Zerbe, who is the Chief Executive Officer and also the Preseident of IntelGenx, said:

“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. 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″.

The company hopes to successfully present data that would show that the CPI-300 does not infringe Biovail’s patent.