IntelGenx Corp. and Cary Pharmaceuticals File NDA for CPI-300 Antidepressant
07 4월 2009 - 7:00PM
Marketwired
IntelGenx Corp. (TSX: IGX)(OTCBB: IGXT) ("IntelGenx") and Cary
Pharmaceuticals Inc. ("Cary Pharma") today announced that a New
Drug Application ("NDA") has been submitted to the U.S. Food and
Drug Administration ("FDA") for their antidepressant CPI-300, a new
strength of a leading antidepressant that will provide a more
convenient dosing option to patients with major depressive disorder
("MDD").
"The filing of the 505(b)(2) NDA for CPI-300 is an important
milestone for IntelGenx as we move one step closer to bringing
forth a new treatment option for patients with MDD," said Dr. Horst
G. Zerbe, President and Chief Executive Officer of IntelGenx. "Not
only are we very excited about the potential of the product, this
achievement validates our skills and expertise in developing new
treatments. It demonstrates our capabilities to take an idea from
conception to completion in a timely, efficient and cost effective
manner. I am very proud of our team of scientists who have worked
diligently and tirelessly on the project, and I am grateful for the
continued excellent support and expertise offered by our partner,
Cary Pharmaceuticals, throughout the development process."
"We are very pleased to have been able to achieve the filing of
the NDA within the targeted timeframe," said Douglas D. Cary,
President and CEO of Cary Pharmaceuticals. "We look forward to
working with the IntelGenx team to execute our commercialization
strategy for CPI-300."
IntelGenx and Cary Pharma entered into a Collaborative Agreement
in November 2007 to jointly develop and commercialize CPI-300 using
IntelGenx's proprietary oral delivery technology. Under the terms
of the Collaborative Agreement, IntelGenx raised $2 million in
March 2008 to fund completion of the product development and Cary
Pharma acted as the applicant for the submission of the NDA. Upon
commercialization of the product, IntelGenx and Cary Pharma would
share profits.
CPI-300:
CPI-300 was formulated using IntelGenx's proprietary controlled
release technology. It contains a new strength of a widely
prescribed antidepressant. CPI-300 was developed to broaden the
dosing options for physicians while providing a more convenient
dosing option for patients requiring a higher strength of the
products currently available. It will be indicated for the
treatment of major depressive disorder.
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. More information is available about the Company
at www.carypharma.com.
Cautionary Note Regarding Forward Looking Statements:
This document contains forward-looking information about the
Company's 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's 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's 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's annual report on Form
10-K for the fiscal year ended December 31, 2008, filed with the
United States Securities and Exchange Commission and available at
www.sec.gov. The Company assumes no obligation to update any such
forward-looking statements.
The TSX Venture Exchange and OTC Bulletin Board have not
reviewed and do not accept responsibility for the adequacy or
accuracy of this release.
Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO
(514) 331-7440 x201 horst@IntelGenx.com www.intelgenx.com Cary
Pharmaceuticals Inc. Douglas D. Cary President and CEO (703)
759-7460 doug.cary@carypharma.com www.carypharma.com
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