IntelGenx Corp and Cary Pharmaceuticals Inc announced that a New Drug Application has been submitted to the US Food and Drug Administration for their antidepressant CPI-300, a new strength of a leading antidepressant that will provide a more convenient dosing option to patients with major depressive disorder (MDD).

"The filing of the 505(b)(2) NDA for CPI-300 is an important milestone for IntelGenx as we move one step closer to bringing forth a new treatment option for patients with MDD," said Dr Horst G Zerbe, president and chief executive officer of IntelGenx. "Not only are we very excited about the potential of the product, this achievement validates our skills and expertise in developing new treatments. It demonstrates our capabilities to take an idea from conception to completion in a timely, efficient and cost effective manner. I am very proud of our team of scientists who have worked diligently and tirelessly on the project, and I am grateful for the continued excellent support and expertise offered by our partner, Cary Pharmaceuticals, throughout the development process."

"We are very pleased to have been able to achieve the filing of the NDA within the targeted timeframe," said Douglas D Cary, president and CEO of Cary Pharmaceuticals. "We look forward to working with the IntelGenx team to execute our commercialization strategy 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. Under the terms of the collaborative agreement, IntelGenx raised $2 million in March 2008 to fund completion of the product development and Cary Pharma acted as the applicant for the submission of the NDA. Upon commercialization of the product, IntelGenx and Cary Pharma would share profits.

CPI-300 was formulated using IntelGenx's proprietary controlled release technology. It contains a new strength of a widely prescribed antidepressant.

IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems.

Cary Pharma is a specialty pharmaceutical company located in Northern Virginia. The company's product pipeline includes CPI-300 for the treatment of depression and QuitPak for smoking cessation.