SAINT LAURENT, QUEBEC and GREAT FALLS, VIRGINIA--(Marketwire - July 30, 2008) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) (“IntelGenx” or the “Company”) and Cary Pharmaceuticals Inc. (“Cary Pharma”) today announced that the companies recently met with the U.S. Food and Drug Administration (FDA) in an End-of-Phase II meeting for its antidepressant, CPI-300 at which the FDA indicated that it will accept a recently completed pivotal food effect study as sufficient to support a 505(b)(2) NDA submission. After reviewing the study results, the FDA confirmed that it will accept a labeling that the product may be taken without regard to food. With respect to the remaining clinical program, the FDA confirmed that it will require a single-dose, fasting, two-way crossover study vs. the Reference Listed Drug (RLD) to support the 505(b)(2) NDA submission. The companies anticipate that the remaining clinical development will be completed in Q3, 2008 and plan to submit the 505(b)(2) NDA in Q4, 2008.
“The End-of-Phase II meeting with FDA is very important to the development program for CPI-300. During this meeting, the FDA provided clarification about the clinical trials and stability studies required to support a 505(b)(2) NDA. We are excited that FDA has provided a clear direction for our CPI-300 development program and our clinical plans. The completion of the pivotal food effect study and its acceptance by the FDA is a critical milestone in our development program. We are now moving full speed ahead to complete the remaining clinical development and stability testing in Q3 2008 with the submission of a 505(b)(2) NDA in Q4 2008,” said Dr. Horst Zerbe, CEO of IntelGenx.
“We are pleased to be partnering with IntelGenx on this important program. The clinical and stability results achieved for CPI-300 are very encouraging. These results provide further confidence that our development team will be able to complete product development in a timely manner,” said Douglas D. Cary, President and CEO of Cary Pharmaceuticals.
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 management, hypertension, osteoarthritis, and depressive disorders.
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, QuitPak(R) for smoking cessation, and Tempol for the treatment of hypertension.
FORWARD LOOKING STATEMENTS
This news release contains certain forward-looking statements. All statements, other than statements of historical fact, included herein, including without limitation, statements regarding potential product development and trial results, and the future plans and objectives of IntelGenx are forward-looking statements that involve various risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from IntelGenx ‘s expectations are disclosed elsewhere in documents that are available to the public at www.sec.gov.
CONTACT INFORMATION:
IntelGenx Corp. Dr. Horst G. Zerbe President and CEO 514-331-7440 (ext. 201) Fax: 514-331-0436 horst@IntelGenx.com www.intelgenx.com
or
Cary Pharmaceuticals Inc. Douglas D. Cary President and CEO 703-759-7460 info@carypharma.com www.carypharma.com
