SAINT LAURENT, QUEBEC--(Marketwire - April 20, 2009) - IntelGenx Corp. (TSX VENTURE: IGX)(OTCBB: IGXT) (“IntelGenx”) today announced the results of a clinical pilot study for a new antihypertensive product. The results of the study indicate that the product is bioequivalent to a leading antihypertensive product brand. The product has been developed using IntelGenx’s proprietary multilayer “Versatab” delivery technology. Versatab provides a patent-protected, cost-effective method of formulating up to three active ingredients in a single dosage form.
On announcing the results Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx, said “We are delighted with these results. This is a significant achievement for IntelGenx that reaffirms our technological capabilities. We are now eager to move forward to the next level of pivotal clinical studies with our partner DAVA Pharmaceuticals.”
Scale-up and manufacturing of the pivotal batches will now commence. In addition, it is anticipated that the pivotal bioequivalence study for the product will be conducted later this year. If the results of the study are satisfactory, it would be followed by the submission of an Abbreviated New Drug Application to the United States Food and Drug Administration.
IntelGenx and DAVA Pharmaceuticals Inc. (“DAVA”) formed a strategic alliance in March 2008. Under the terms of the alliance, IntelGenx is responsible for product development using its patented proprietary delivery technologies. DAVA is responsible for commercialization and marketing activities in the United States. IntelGenx is entitled to fees for the development of the product, as well as a share of DAVA’s gross profit from any product sales in the United States. According to IMS Health, peak sales for the leading antihypertensive product brand exceeded $1.5 billion in the United States in 2007.
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.
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.
The TSX Venture Exchange and OTCBB have not reviewed and do not accept responsibility for the adequacy or accuracy of this press release.
Contacts:
IntelGenx Corp.
Dr. Horst G. Zerbe
President and CEO
(514) 331-7440 x201
horst@IntelGenx.com
www.intelgenx.com