IntelGenx Submits Reply to FDA Complete Response Letter for its Single Dose 450 mg Bupropion Hydrochloride Tablet
New PDUFA Date Expected 2H2011
SAINT LAURENT, QUEBEC--(Marketwire - May 16, 2011) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") today announced that it has submitted its reply to a Complete Response Letter issued in February 2010 by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for its antidepressant CPI-300. CPI-300 is a novel, high strength of Bupropion Hydrochloride (HCl), the active ingredient in Wellbutrin XL®.
The Company's new submission addresses 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, in the food effect study submitted as part of the NDA. In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the Company with an updated Prescription Drug User Fee Act (PDUFA) target action date within weeks.
"We are confident that we have addressed the requests that were outlined by the FDA in their Complete Response Letter," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We will continue to work closely with the FDA as it moves forward with their NDA review."
Dr. Zerbe added, "We are actively discussing commercialization rights and strategies for CPI-300 with a number of interested potential partners. Furthermore we are very pleased to have the Biovail litigation behind us, so that CPI-300 can immediately be marketed upon approval."
CPI-300 is a novel, high strength formulation of Bupropion HCl the active ingredient in Wellbutrin XL®. CPI-300 would be the only single pill, high strength, formulation of Bupropion HCl on the market. At present, patients requiring a high dosage are prescribed multiples of the lower strengths of the Bupropion HCl tablets.
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 pain, hypertension, erectile dysfunction 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' 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.
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