IntelGenx Corp. and Cary Pharmaceuticals File NDA for CPI-300 Antidepressant

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Tue Apr 7, 2009 6:04am EDT

  SAINT LAURENT, QUEBEC AND GREAT FALLS, VIRGINIA, Apr
07 (MARKET WIRE) -- 
IntelGenx Corp. (TSX: IGX)(OTCBB: IGXT) ("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:

    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(R) 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.


 
 The TSX Venture Exchange and
OTC Bulletin Board have not reviewed and do not accept responsibility for
the adequacy or accuracy of this release.

Contacts:
IntelGenx Corp.
Dr. Horst G. Zerbe
President and CEO
(514) 331-7440 x201
horst@IntelGenx.com
www.intelgenx.com

Cary Pharmaceuticals Inc.
Douglas D. Cary
President and CEO
(703) 759-7460
doug.cary@carypharma.com
www.carypharma.com

Copyright 2009, Market Wire, All rights reserved.

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