Saint Laurent, Quebec--(Newsfile Corp. - August 7, 2012) - IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx") today announced financial results for the three and six month periods ended June 30, 2012 and highlighted recent business developments. All amounts are in U.S. dollars, unless otherwise stated.
“Following the execution of our licence agreement with Edgemont Pharma in Q1, we were very busy throughout the second quarter with supporting the manufacturing activities and preparation of launch activities for Forfivo XL®, which we anticipate will occur later in Q3” stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. “In addition, we announced positive pivotal study results for our anti-migraine VersaFilm™ product demonstrating that our product is bioequivalent to Merck’s orally disintegrating tablet Maxalt-MLT®. The NDA for this product will be filed as soon as sufficient product stability data has been generated.”
Dr. Zerbe added, “We continue to be very pleased with the excellent progress being made with our undisclosed project with Par Pharmaceutical”.
Anti-migraine VersaFilm™ (rizatriptan):
On May 29, 2012 we announced the completion of the pivotal bioequivalence study for a novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT® orally disintegrating tablets. Maxalt-MLT® is a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt® grew 16% to $639 million in 2011. The thin-film formulation of rizatriptan has been developed using our proprietary immediate release "VersaFilm™" drug delivery technology. The film is now undergoing a pivotal stability study, with a 505(b)(2) new drug application expected to be filed with the FDA in the first quarter of 2013.
We developed our anti-migraine VersaFilm™ product in accordance with the co-development and commercialization agreement with RedHill Biopharma Ltd. ("RedHill"), an Israeli corporation, which was executed in August 2010. Under the terms of the agreement, RedHill obtained certain exclusive worldwide rights to market and sell our rapidly dissolving anti-migraine oral film product and in exchange we received upfront and milestone payments, and will receive additional milestone payments and external development fees. Furthermore, upon commercialization of the product, we are entitled to receive a share of all proceeds including, but not limited to, all sales milestones and income from the product world-wide
Forfivo XL® Anti-depressant VersaTab™ (bupropion):
On February 14, 2012 we announced an exclusive agreement with Edgemont Pharmaceuticals, LLC (“Edgemont”) for the commercialization of our lead product, Forfivo XL® (formerly CPI-300), in the United States.
Under the terms of the agreement, Edgemont has obtained certain exclusive rights to market and sell Forfivo XL® in the U.S. In exchange, we received a $1.0 million upfront payment and could receive launch related milestones totaling up to $4.0 million. In addition, we will be eligible for milestones of up to $23.5 million upon achieving certain sales and exclusivity targets, and we will receive double-digit royalties on the net sales of Forfivo XL®.
We expect Forfivo XL® to be commercially launched by Edgemont in the third quarter of 2012.
Forfivo XL® is a novel, high strength formulation of bupropion HCl, the active ingredient in Wellbutrin XL®. When launched, Forfivo XL® will provide high dose bupropion XL patients the opportunity to achieve their entire daily dose in a single pill versus the multiple pills they currently need to take. Reducing the number of tablets per dose significantly increases patient compliance and reduces the chance of an accidental overdose. These two factors are recognised as well-published and important clinical benefits.
We had cash of $3.1 million as at June 30, 2012, which represents a decrease of approximately $0.4 million from our cash position as at December 31, 2011 and is slightly below our cash position of $3.2 million at the end of June 2011. In the first six months of 2012 we used cash of $1.2 million and $0.2 million for operating activities and investments respectively, which was partly offset by the generation of $0.7 million in cash from changes in assets and liabilities, together with $0.2 million in cash from the exercise of warrants.
Revenue and other income was $0.1 million in the first half of 2012, compared with $0.1 million in the first six months of 2011.
Total expenses were $1.3 million in the first six months of 2012, compared with $1.3 million in the same period of 2011.
The net loss was $1.2 million in the first half of 2012, compared with $1.2 million in the first six months of 2011, and the basic and diluted loss per share for the first six months improved by 1 cent from $0.03 in 2011 to $0.02 in 2012.
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' 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.
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, 2011, 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 OTCQX 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