Positive Bioequivalence Results for IntelGenx Developed Product
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SAINT LAURENT, QUEBEC, Apr 20 (MARKET WIRE) --
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
Copyright 2009, Market Wire, All rights reserved.
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