SAINT LAURENT, QUEBEC, May 11, 2011 - IntelGenx Technologies Corp. (TSX VENTURE: IGX) (OTCBB: IGXT) ("IntelGenx") today announced its financial results for the three month period ended March 31, 2011 and highlighted recent business developments. All amounts are in U.S. dollars, unless otherwise stated.
“The news that the United States District Court of Delaware had ruled in our favour regarding claim construction at the Markman Hearing, and the subsequent dismissal of the Biovail litigation, was an excellent start to the New Year,” commented Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. “The dismissal of the litigation allowed us to make significant advances in partnership discussions for CPI-300, and we are finalising our response to address FDA's questions from the Complete Response Letter, which we plan to submit to the Agency by next week. At the same time we have continued to make substantial progress with our VersaFilm™ technology and have, in the past few months, successfully completed pilot studies for anti-psychotic and insomnia products.”
CPI-300 Antidepressant Tablet:
On January 4, 2011, we announced that the United States District Court of Delaware has ruled in our favour regarding claim construction for the two patent terms at issue in the patent infringement action brought forward by Biovail. The ruling arose from a special proceeding required under U.S. patent law called a "Markman Hearing" wherein both sides presented to the court their arguments on how they believe the patent terms at issue should be interpreted.
On February 3, 2011, we announced that the United States District Court of Delaware had dismissed the lawsuit against us. Biovail and IntelGenx agreed to dismissal of the action following the ruling on the Markman Hearing.
We expect to file the amendment to the NDA in the second quarter of 2011.
On February 7, 2011, we announced the completion of a pilot study that indicates that we have successfully developed a novel oral film, INT0022, which is likely to be bioequivalent to a leading anti-psychotic in a pivotal bioequivalency study. INT0022 has been developed using our proprietary immediate release "VersaFilm™" drug delivery technology. According to IMS Health, the global anti-psychotic market was worth $22.5 billion in 2008.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether INT0022 will be bioequivalent to a leading anti-psychotic product in a pivotal bioequivalency study as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC). The study results indicate that INT0022 will likely be bioequivalent with the brand product and allow us to advance the product to the pivotal stage.
Subsequent to the end of the quarter, on April 6, 2011 we announced the completion of a pilot biostudy indicating that we have developed a novel oral film, INT0020, that suggests bioequivalency to a leading branded product for the treatment of insomnia. INT0020 has been developed using our proprietary immediate release "VersaFilm™" drug delivery technology.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether INT0020 is bioequivalent to a leading insomnia product as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC). The study results indicate that INT0020 should meet acceptance criteria for bioequivalency for both Cmax and AUC once we decide to advance the product to the larger pivotal bioequivalency study.
|In millions of U.S. $ except Per Share Data||As of quarter ended
March 31, 2011
|As of quarter ended
March 31, 2010
|Loss Per Share||$0.01||$0.02|
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.
Each of the TSX Venture Exchange and OTC Bulletin Board has neither approved nor disapproved the contents of this press release.
Dr. Horst G. Zerbe,
President and CEO
IntelGenx Technologies Corp.
T: +1 514-331-7440 (ext. 201)
F: +1 514-331-0436