IntelGenx Receives FDA Complete Response Letter CPI-300
SAINT LAURENT, QUEBEC, Feb 08, 2010 (MARKETWIRE via COMTEX) -- IntelGenx Corp. (IGX)(US:IGXT) ("IntelGenx") today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") regarding the Company's New Drug Application ("NDA") for its antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma"). CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL(R). IntelGenx's development partner, Cary Pharma, serves as the NDA applicant for CPI-300.
The FDA issues Complete Response Letters to request additional information needed to complete the review of an NDA. As expected, the Complete Response Letter lists two main issues which need to be addressed in order to obtain approval, 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. Other than these two issues, which management believes can be effectively addressed, the FDA found no other notable deficiencies in the NDA.
"This Complete Response Letter gives us the clarity and confidence necessary to complete the development of CPI-300 and push towards the submission of an NDA amendment in the second half of this year," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "There were no surprises for us in the letter, as we had alerted FDA to the manufacturing issue ourselves and have been aware of the agency's sensitivity towards the food effect which is being observed in all bupropion extended-release products. That has allowed us to proactively manage the situation and stay on course for a possible late 2010 FDA approval."
As noted in a January 11, 2010 press release, IntelGenx notified the FDA of its intent to switch its contract manufacturing organization ("CMO"). The Company has already identified a new CMO and has begun the process of generating the data required to support an amendment to its NDA.
In its Complete Response Letter FDA also notes of a possible food affect with CPI-300. The Company believes this issue can be overcome through a label adjustment and a thorough post-approval educational effort. In the coming weeks the Company will make a request for a meeting with FDA to clarify the required steps necessary to obtain product approval. The Company is confident that the activities required to support the NDA amendment can be completed in time for a submission in the second half of 2010.
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.
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. 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'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.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx'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, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
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IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
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