Friday, November 11, 2011 6:29:37 AM
News for 'IGXT' - (IntelGenx Announces FDA Approval of Its High Dose Anti-Depressant CPI-300)
SAINT LAURENT, Quebec, Nov 11, 2011 (GlobeNewswire via COMTEX) -- IntelGenx
Corp. (TSX-V:IGX) (OTCBB:IGXT) ("IntelGenx") today announced that the U.S. Food
and Drug Administration (FDA) has approved IntelGenx' lead product, CPI-300, for
patients with Major Depressive Disorder. CPI-300 is a novel, high-strength
formulation of Bupropion hydrochloride (HCl), the active ingredient in
Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion
HCl approved by the FDA.
"This is a defining moment for IntelGenx, as we have now clearly demonstrated
our ability to independently take a product through development to regulatory
approval," said Dr. Horst G. Zerbe, President and Chief Executive Officer of
IntelGenx. "We believe physicians will embrace CPI-300 as a more convenient and
safe alternative for their patients requiring high-dose anti-depressant therapy.
So we now turn our focus towards the commercialization of CPI-300, with the
objective of a product launch with a partner by the second quarter of 2012."
IntelGenx has been in active licensing discussions with several leading generic
and specialty pharmaceutical companies and anticipates finalizing a
commercialization agreement soon. As previously announced, the company has
entered into an agreement with Pillar5 Pharma Inc. for the commercial
manufacturing of the product.
About IntelGenx
IntelGenx 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 severe depression, hypertension, erectile
dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder,
idiopathic pulmonary fibrosis, allergies and pain management. 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 unc ertainties,
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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: IntelGenx Corp.
By Staff
CONTACT: CONTACT: IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
Tel: +1 514-331-7440 (ext. 201)
Fax: +1 514-331-0436
horst@intelgenx.com
www.intelgenx.com
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.
-0-
INDUSTRY KEYWORD: Biotechnology
SUBJECT CODE: MEDICAL
& nbsp; PHARMACEUTICALS
Product Services Announcement
SAINT LAURENT, Quebec, Nov 11, 2011 (GlobeNewswire via COMTEX) -- IntelGenx
Corp. (TSX-V:IGX) (OTCBB:IGXT) ("IntelGenx") today announced that the U.S. Food
and Drug Administration (FDA) has approved IntelGenx' lead product, CPI-300, for
patients with Major Depressive Disorder. CPI-300 is a novel, high-strength
formulation of Bupropion hydrochloride (HCl), the active ingredient in
Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion
HCl approved by the FDA.
"This is a defining moment for IntelGenx, as we have now clearly demonstrated
our ability to independently take a product through development to regulatory
approval," said Dr. Horst G. Zerbe, President and Chief Executive Officer of
IntelGenx. "We believe physicians will embrace CPI-300 as a more convenient and
safe alternative for their patients requiring high-dose anti-depressant therapy.
So we now turn our focus towards the commercialization of CPI-300, with the
objective of a product launch with a partner by the second quarter of 2012."
IntelGenx has been in active licensing discussions with several leading generic
and specialty pharmaceutical companies and anticipates finalizing a
commercialization agreement soon. As previously announced, the company has
entered into an agreement with Pillar5 Pharma Inc. for the commercial
manufacturing of the product.
About IntelGenx
IntelGenx 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 severe depression, hypertension, erectile
dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder,
idiopathic pulmonary fibrosis, allergies and pain management. 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 unc ertainties,
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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: IntelGenx Corp.
By Staff
CONTACT: CONTACT: IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
Tel: +1 514-331-7440 (ext. 201)
Fax: +1 514-331-0436
horst@intelgenx.com
www.intelgenx.com
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.
-0-
INDUSTRY KEYWORD: Biotechnology
SUBJECT CODE: MEDICAL
& nbsp; PHARMACEUTICALS
Product Services Announcement
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