SAINT LAURENT, QUEBEC--(Marketwire - Nov. 29, 2010) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCBB:IGXT) ("IntelGenx") today announced that it has acquired exclusive rights to, and ownership of, INT0010, an improved formulation of THC (dronabinol) for the symptomatic management of Multiple Sclerosis (MS) induced neuropathic pain and chemotherapy induced nausea. These markets are multi-billion dollar markets worldwide, and believed to be growing.
IntelGenx entered into a royalty based licensing agreement with PediPharm Ltd. Under the terms of the agreement, IntelGenx has obtained worldwide rights to US Patent 7,592,328 and all corresponding foreign patents and patent applications to exclusively develop and further provide intellectual property protection for INT0010. PediPharm would receive a signing fee and a milestone payment upon IntelGenx securing a commercialisation partner for the product, along with a royalty from all sales of the product world-wide.
IntelGenx has also executed a binding Memorandum of Understanding with Cynapsus Therapeutics ("Cynapsus"), its former development partner whereby, for forgiveness of debt and a royalty on future sales of the product, IntelGenx has acquired full control of, and interest in, INT0010 going forward.
"We are very excited to have acquired full control and ownership of INT0010 at this critical juncture in the product's development" commented Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "The product has already completed a successful Phase I study demonstrating increased bioavailability of dronabinol and reduced levels of its psychotropic metabolite versus the existing FDA approved THC product. INT0010 is a unique, patent protected formulation with the potential to become a billion dollar product. We believe this is the right time for a commercial partner to step in and advance the project and are currently in discussions with several companies that have expressed an interest in commercializing the product."
INT0010 is an improved delivery option for THC (dronabinol) for the symptomatic management of neuropathic pain. INT0010 delivers more than twice the amount of dronabinol into the bloodstream relative to the reference drug Marinol (as measured by AUC) but only about one-half of the main metabolite 11-hydroxy tetrahydrocannabinol which is mainly responsible for the psychotropic effect of the drug. Thus the undesired CNS side effects associated with dronabinol are expected to be reduced significantly. INT0010 is formulated using patented and patent pending technology and has the potential to be the only solid dosage form capable of providing absorption of dronabinol in the oral cavity.
INT0010 has clinically demonstrated increased bioavailability and the potential to reduce the dose required for efficacy.
INT0010 was successfully studied in a Phase I safety and pharmacokinetic clinical trial (results announced on April 14, 2009). Results verified the AdVersa technology by proving buccal absorption of the drug leading to increased bioavailability with a reduced level of the psychoactive metabolite.
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, 2009, 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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