SAINT LAURENT, QUEBEC, Jan 11, 2010 (MARKETWIRE via COMTEX) -- IntelGenx Corp. (IGX)(US:IGXT) ("IntelGenx") today announced a manufacturing site change 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 New Drug Application ("NDA") applicant for CPI-300.
IntelGenx originally engaged PharmPro of Aurora, Illinois ("PharmPro") for the manufacturing components of the CPI-300 New Drug Application (NDA) and subsequent commercial production. However, PharmPro sold its Aurora manufacturing facility and assets to URL Pharma of Philadelphia, Pennsylvania. As a result of this acquisition, IntelGenx was recently advised that the new owners did not intend to operate the manufacturing facility in Aurora as a Contract Manufacturing Operation ("CMO").
IntelGenx has identified and engaged an alternative CMO, Pillar5 Pharma, as the new manufacturing facility for CPI-300. Pillar5 Pharma acquired the former Pfizer Inc. manufacturing site in Arnprior, Ontario from Keata Pharma Inc. in December 2009. Arnprior is a state-of-the-art GMP facility with a long-standing record of manufacturing quality product for the pharmaceutical industry.
As a result of the manufacturing site change, IntelGenx and Cary Pharma are in the process of discussing with FDA the preparation of an amendment to their NDA, which will be filed with FDA in due course. IntelGenx is also in the process of qualifying the Pillar5 Pharma site for the manufacture of exhibit batches of CPI-300, required to support the amendment, as well as for the future production of commercial product. Although this process is expected to cause a delay to the receipt of FDA approval of the NDA and to the commercialization of the product, IntelGenx expects that the changes will not materially affect the existing timeline for commercialization of CPI-300.
"Once we became aware of the situation with PharmPro we began a process to identify new and more stable contract manufacturing for CPI-300 and other of our tablet products. So although the decision by the acquirer of the PharmPro facility, URL Pharma, to not continue as a CMO disappoints us, we were already well down the path of engaging a new strategic manufacturing partner," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "Although this represents a delay in our NDA approval, considering the ongoing Paragraph IV litigation with Biovail, we believe that the projected timing of commercialization should be minimally impacted. We hope to be able to shed further light on the approval process and our NDA amendment once we hear back from the FDA on our February 6th PDUFA date."
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
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