IntelGenx Announces Successful Pre-Approval Inspection of its Lead Product CPI-300
August 02 2011 - 5:00AM
Marketwired
IntelGenx Corp. (TSX VENTURE: IGX)(OTCBB: IGXT) ("IntelGenx") today
announced that Pillar5 Pharma Inc. ("Pillar5") successfully passed
a pre-approval inspection by the U.S. Food and Drug Administration
(FDA) for IntelGenx' lead product, CPI-300, a novel antidepressant,
with a high strength of bupropion hydrochloride (HCl), which is the
active ingredient in Wellbutrin XL®.
Pillar5, the contract manufacturing organization ("CMO")
selected by IntelGenx for the manufacture of CPI-300, successfully
responded to all queries from the FDA for its pre-approval site
inspection. As expected, the inspection lasted 4 days and concluded
with no Form 483 being issued. Form 483 lists observations made by
the FDA representative(s) during the inspection of a facility. Such
observations are inspectional observations, and do not represent a
final Agency determination regarding a facility's compliance.
"First and foremost, we would like to congratulate Pillar5 on
this excellent achievement," said Dr. Horst G. Zerbe, President and
Chief Executive Officer of IntelGenx. "We are very excited to have
passed another important milestone in our endeavors to bring
CPI-300 to market and hopefully make this proprietary product
available to patients who suffer from major depressive
disorder."
IntelGenx recently submitted its reply to a "Complete Response
Letter" issued in February 2010 by the FDA after its review of
IntelGenx' New Drug Application (NDA) submission for CPI-300.
IntelGenx' reply addressed the two main issues identified by the
FDA in the Complete Response Letter, namely the qualification of a
commercial manufacturing site and the food effect, which was
observed both in CPI-300 and the reference product. FDA has
accepted IntelGenx' submission and has established November 13,
2011 as its target action date under the Prescription Drug User Fee
Act ("PDUFA").
As announced on May 4, 2010, IntelGenx has an ownership stake in
Pillar5, representing 10% of the issued and outstanding shares of
Pillar5.
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.
About Pillar5:
Pillar5 Pharma Inc. is a private company based in Arnprior,
Ontario. The Arnprior manufacturing facility was established in
1956 by Pfizer and has been operated by Pillar5 since 2009. With
nearly 100 employees, the facility has a long-standing record of
manufacturing quality product for the pharmaceutical industry and
"a foundation of excellence". With millions of dollars in
investment over the past many years, the Arnprior manufacturing
facility is equipped with state-of-the-art equipment,
infrastructure and processes, along with proven expertise in the
manufacturing and packaging of oral solid and sterile ophthalmic
products.
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 Technologies 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
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