SAINT LAURENT, QUEBEC, Nov 17, 2009 (MARKETWIRE via COMTEX) -- IntelGenx Corp. (IGX)(US:IGXT) ("IntelGenx") is pleased to announce the results of a clinical pilot study that suggests IntelGenx has successfully developed a product that is bioequivalent to a leading branded anti-migraine therapy. The product (INT008) has been developed using IntelGenx's proprietary immediate release film "VersaFilm™" drug delivery technology. VersaFilm™ provides a patent-protected method of formulating in a convenient and discrete dosage form.
"The achievement of bioequivalence in this pilot study puts IntelGenx at the forefront of immediate release film development, as we believe this to be the first successful human study of an anti-migraine film," commented Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "The data and the lessons learned from this initial bioequivalence study will be valuable in our development of other film medicines, most notably our erectile dysfunction film which is another priority product we are currently working on."
With the completion of the pilot study, scale-up and manufacturing of the pivotal INT008 batches will now commence. It is anticipated that the pivotal bioequivalence study will be conducted in early 2010 and the Company will endeavor to file the NDA in the fourth quarter of the same year.
Dr. Zerbe added, "We believe that film delivery offers a discreet and convenient alternative to other oral delivery systems, which should also improve patient compliance. These attributes should allow INT008 to not only compete against the existing branded anti-migraine product but also other drugs within the anti-migraine segment."
Audited 2008 sales of the branded anti-migraine product in the United States were several hundred million dollars. IntelGenx currently is seeking a development and marketing partner for INT008.
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. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal 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. IntelGenx'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.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx'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, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has neither approved nor disapproved the contents of this press release.
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)