Healthcare Industry News: IntelGenx
News Release - April 7, 2009
IntelGenx Corp. and Cary Pharmaceuticals File NDA for CPI-300 AntidepressantSAINT LAURENT, QUEBEC and GREAT FALLS, VIRGINIA--(Healthcare Sales & Marketing Network)--Apr 7, 2009 -- IntelGenx Corp. (CDNX:IGX.V )(OTC BB:IGXT.OB ) ("IntelGenx") and Cary Pharmaceuticals Inc. ("Cary Pharma") today announced that a New Drug Application ("NDA") has been submitted to the U.S. Food and Drug Administration ("FDA") 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. CPI-300 was developed to broaden the dosing options for physicians while providing a more convenient dosing option for patients requiring a higher strength of the products currently available. It will be indicated for the treatment of major depressive disorder.
About IntelGenx Corp.:
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. The Company uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastro-intestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. The Company's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders. More information is available about the Company at www.IntelGenx.com.
About Cary Pharmaceuticals Inc.:
Cary Pharmaceuticals Inc. 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. More information is available about the Company at www.carypharma.com.
Cautionary Note Regarding Forward Looking Statements:
This document contains forward-looking information about the Company's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K for the fiscal year ended December 31, 2008, filed with the United States Securities and Exchange Commission and available at www.sec.gov. The Company assumes no obligation to update any such forward-looking statements.
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