IntelGenx’s Anti-Depressant, CPI-300, Receives FDA Approval

IntelGenx Corp. (CA:IGX)(OTCBB:IGXT) is a publicly traded drug delivery company specializing in the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. On Friday, November 11, the company announced the FDA-approval of their lead product, CPI-300, for patients with Major Depression Disorder.

CPI-300 is a high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. IntelGenx is at the forefront of the industry with CPI-300 being the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.

“This is a defining moment for IntelGenx, as we have now clearly demonstrated our ability to independently take a product through development to regulatory approval,” said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. “We believe physicians will embrace CPI-300 as a more convenient and safe alternative for their patients requiring high-dose anti-depressant therapy. So we now turn our focus towards the commercialization of CPI-300, with the objective of a product launch with a partner by the second quarter of 2012.”

IntelGenx has developed a broad and diverse product portfolio, including products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management. Aside from CPI-300, the IntelGenx has three proprietary delivery platforms, including an immediate release oral film, VersaFilm; a mucoadhesive tablet, AdVersa; and multilayer controlled release tablet, VersaTab. The Company has an aggressive product development initiative that primarily focuses on addressing unmet market needs.

The Company’s broad product pipeline demonstrates vast opportunity for investors: unique drug delivery services; patented technology and strong Intellectual Property Portfolio; first product commercialized in 11/2008; products addressing multi-billion dollar markets; strong market and key scientific expertise; Strategic R&D and commercial partnerships in place.

IntelGenx shares, which have gained 45 percent of their value so far this year, closed at 58 Canadian cents on Thursday, November 10, on the Toronto Venture Exchange.

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