IntelGenx Corp. Set to File NDA for Antidepressant
October 09 2008 - 7:14AM
Marketwired
IntelGenx Corp. (TSX: IGX)(OTCBB: IGXT) ("IntelGenx") and Cary
Pharmaceuticals Inc. ("Cary Pharma") today announced positive
results from a clinical trial on its antidepressant CPI 300. The
results from the bioequivalence study undertaken in September 2008
confirm that CPI 300 is bioequivalent to the reference product.
IntelGenx and Cary Pharma will be filing a New Drug Application
("NDA") (505(b)(2) based on the successful results of this study.
Approval of the product is expected during the second half of 2009.
"This is fantastic news as it clearly demonstrates that our
development team has mastered all of the hurdles required to file
an NDA for a patented product to compete in a $1.6 billion market,"
said Dr. Horst Zerbe, President and CEO of IntelGenx. He added "We
are now able to concentrate our efforts on completing the
compilation of documentation for the 505(b)(2) NDA filing with the
FDA. I am very proud of our team of experts who not only
successfully developed this product within the allotted timeframe,
but also within budget."
"Our research shows that more than 1.0 million prescriptions
were dispensed for the higher dosage of this antidepressant during
2007 and we will be the sole provider of this medication in a
single tablet. I am very excited by these results" said Douglas D.
Cary, President and CEO of Cary Pharmaceuticals.
CPI 300:
CPI-300 was formulated using IntelGenx's proprietary controlled
release technology. It contains a new strength of antidepressant
developed to complete the dosing options for physicians who
currently prescribe the drug. CPI-300 provides a more convenient
dosing option for those patients currently taking the higher
strength. It will be indicated for the treatment of major
depressive disorder (MDD).
Major Depressive Disorder:
Major depressive disorder is also known as major depression,
clinical depression, or unipolar depression. Major Depressive
Disorder is the leading cause of disability in the U.S. for ages
15-44. It affects approximately 14.8 million American adults, or
about 6.7 percent of the U.S. population age 18 and older in a
given year.
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� for
smoking cessation.
Forward Looking Statements:
This release may contain forward-looking statements. Various
factors could cause actual results to differ materially from those
projected in forward-looking statements. Although the Company
believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that the Company's
expectations are correct. All forward-looking statements are
expressly qualified in their entirety by this cautionary
statement.
The TSX and OTCBB have neither approved nor disapproved of the
information contained herein.
Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO
(514) 331-7440 x201 Email: horst@IntelGenx.com Website:
www.intelgenx.com Cary Pharmaceuticals Inc. Douglas D. Cary
President and CEO (703) 759-7460 Email: doug.cary@carypharma.com
Website: www.carypharma.com
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