IntelGenx Submits Reply to FDA Complete Response Letter for its Single Dose 450 mg Bupropion Hydrochloride Tablet
May 16 2011 - 05:00AM
Marketwired
IntelGenx Corp. (TSX VENTURE: IGX)(OTCBB: IGXT) ("IntelGenx") today
announced that it has submitted its reply to a Complete Response
Letter issued in February 2010 by the U.S. Food and Drug
Administration (FDA) after review of the New Drug Application (NDA)
submission for its antidepressant CPI-300. CPI-300 is a novel, high
strength of Bupropion Hydrochloride (HCl), the active ingredient in
Wellbutrin XL®.
The Company's new submission addresses 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, in the food effect study submitted as part of the NDA. In
accordance with its guidelines, the FDA is expected to classify the
complete response as a Class 1 or Class 2 resubmission, and also
provide the Company with an updated Prescription Drug User Fee Act
(PDUFA) target action date within weeks.
"We are confident that we have addressed the requests that were
outlined by the FDA in their Complete Response Letter," said Dr.
Horst G. Zerbe, President and Chief Executive Officer of IntelGenx.
"We will continue to work closely with the FDA as it moves forward
with their NDA review."
Dr. Zerbe added, "We are actively discussing commercialization
rights and strategies for CPI-300 with a number of interested
potential partners. Furthermore we are very pleased to have the
Biovail litigation behind us, so that CPI-300 can immediately be
marketed upon approval."
About CPI-300
CPI-300 is a novel, high strength formulation of Bupropion HCl
the active ingredient in Wellbutrin XL®. CPI-300 would be the only
single pill, high strength, formulation of Bupropion HCl on the
market. At present, patients requiring a high dosage are prescribed
multiples of the lower strengths of the Bupropion HCl tablets.
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 pain, hypertension,
erectile dysfunction 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
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