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Tuesday, June 14, 2011 6:08:09 AM
SAINT LAURENT, QUEBEC, Jun 14, 2011 (MARKETWIRE via COMTEX) -- IntelGenx Corp.
(TSX VENTURE: IGX)(OTCBB: IGXT) ("IntelGenx", or "the Company"), announced that
the U.S. Food and Drug Administration ("FDA") has accepted the Company's
resubmission of its antidepressant CPI-300 New Drug Application 505(b)(2) in
response to the February 2010 Complete Response Letter ("CRL") as a complete,
Class 2 response. In addition, the FDA has established November 13, 2011 as its
target action date under the Prescription Drug User Fee Act ("PDUFA"). CPI-300
is a novel, high strength of Bupropion Hydrochloride (HCl), the active
ingredient in Wellbutrin XL(R).
"We are very pleased to note that FDA considers our response to be complete,"
said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "As
expected, FDA considers our resubmission a class 2 response to the CRL and, as
such, has issued a PDUFA target date of 6 months from the date of our
resubmission. We look forward to working with the FDA during the review process
and, following approval, making this proprietary product available to patients
who suffer from major depressive disorder."
About IntelGenx:
Intel Genx 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' research and development pipeline
includes products for the treatment of pain, hypertension, erectile dysfunction,
sleep disorders, allergies 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' 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' 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' 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' annual report on Form 10-K for
the fiscal year ended December 31, 2010, 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.
Contacts:
IntelGenx Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
+1 514-331-0436 (FAX)
horst@intelgenx.com
www.intelgenx.com
SOURCE: IntelGenx Corp.
CONTACT: mailto:horst@intelgenx.com
http://www.intelgenx.com
Copyright 2011 Marketwire, Inc., All rights reserved.
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SUBJECT CODE: Medical and Healthcare:Health and Nutrition
Medical and Healthcare:Healthcare
Pharmaceuticals and Biotech:Trials
Pharmaceuticals and Biotech:Drugs
Pharmaceuticals and Biotech:Biotech
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