IntelGenx Announces Successful Pre-Approval Inspection of its Lead Product CPI-300
SAINT LAURENT, QUEBEC, Aug 02, 2011 (MARKETWIRE via COMTEX) -- IntelGenx Corp. today announced that Pillar5 Pharma Inc. ("Pillar5") successfully passed a pre-approval inspection by the U.S. Food and Drug Administration (FDA) for IntelGenx' lead product, CPI-300, a novel antidepressant, with a high strength of bupropion hydrochloride (HCl), which is the active ingredient in Wellbutrin XL(R).
Pillar5, the contract manufacturing organization ("CMO") selected by IntelGenx for the manufacture of CPI-300, successfully responded to all queries from the FDA for its pre-approval site inspection. As expected, the inspection lasted 4 days and concluded with no Form 483 being issued. Form 483 lists observations made by the FDA representative(s) during the inspection of a facility. Such observations are inspectional observations, and do not represent a final Agency determination regarding a facility's compliance.
"First and foremost, we would like to congratulate Pillar5 on this excellent achievement," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We are very excited to have passed another important milestone in our endeavors to bring CPI-300 to market and hopefully make this proprietary product available to patients who suffer from major depressive disorder."
IntelGenx recently submitted its reply to a "Complete Response Letter" issued in February 2010 by the FDA after its review of IntelGenx' New Drug Application (NDA) submission for CPI-300. IntelGenx' reply addressed 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. FDA has accepted IntelGenx' submission and has established November 13, 2011 as its target action date under the Prescription Drug User Fee Act ("PDUFA").
As announced on May 4, 2010, IntelGenx has an ownership stake in Pillar5, representing 10% of the issued and outstanding shares of Pillar5.
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 severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com .
Pillar5 Pharma Inc. is a private company based in Arnprior, Ontario. The Arnprior manufacturing facility was established in 1956 by Pfizer and has been operated by Pillar5 since 2009. With nearly 100 employees, the facility has a long-standing record of manufacturing quality product for the pharmaceutical industry and "a foundation of excellence". With millions of dollars in investment over the past many years, the Arnprior manufacturing facility is equipped with state-of-the-art equipment, infrastructure and processes, along with proven expertise in the manufacturing and packaging of oral solid and sterile ophthalmic products.
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.
IntelGenx Technologies Corp.
Dr. Horst G. Zerbe
President and CEO
+1 514-331-7440 (ext. 201)
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