Saint Laurent, Quebec--(Newsfile Corp. - May 14, 2013) - IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company") today announced financial results for the quarter ended March 31, 2013 and provided an update on operational developments.
"The first quarter of 2013 was another busy period at IntelGenx with the recruitment of Dr. Rajiv Khosla and the filing of a 505(b)(2) NDA for our VersaFilm™ rizatriptan for the treatment of migraines" stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Dr. Khosla has agreed to join the Company, initially as COO & CSO and, with effect from January 2014, as CEO. With his track record of success in business development and in leading growth in our sector, I am convinced that we have the right person to manage IntelGenx into the future. The team at IntelGenx pulled together with the team at RedHill to ensure that our NDA was filed before the end of Q1. This was an excellent effort on all sides. We expect the NDA will be subject to a standard review by the FDA, and are optimistic that the review could be completed as early as the first half of 2014."
Dr. Rajiv Khosla added, "I want to thank Horst and the rest of the board of directors for the opportunity to join the IntelGenx team. Our portfolio of drug delivery technologies could make the company the drug delivery company of choice in the industry".
Corporate Development Update
Anti-migraine VersaFilm™ (rizatriptan)
In March 2013 we announced that, together with our co-development partner RedHill Biopharma Ltd. ("RedHill"), we submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for our anti-migraine oral film product, a novel oral thin-film formulation based on our proprietary VersaFilm™ technology containing rizatriptan, the active drug in Merck & Co. ("Merck's") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012.
Erectile Dysfunction VersaFilm(TM) (tadalafil)
In February 2013 we successfully completed a pilot bioequivalence study on our erectile dysfunction VersaFilm(TM) product. In a previous study, we had already demonstrated that we are able to formulate a bioequivalent product. In the recently completed study, we showed that we were additionally able to develop a faster formulation with a significantly shorter Tmax which will address the potential need for a faster tadalafil product. We are in active discussions for the licensing of this product.
Development and Commercialization Agreement with Par Pharmaceutical, Inc.
In December 2011 we announced the execution of a co-development and commercialization agreement with Par Pharmaceutical, Inc. ("Par") for a new product utilizing one of our proprietary oral drug delivery platform technologies. This program continues to make progress. For commercial reasons, and in order to protect both Par's and IntelGenx' competitive advantage, the agreement stipulates that all information pertaining to the product, together with financial terms of the agreement, are to remain confidential.
Antihypertensive VersaTab(TM) product
We recently completed a pilot bioequivalence study for our antihypertensive project, INT0001, a generic equivalent to a major cardiovascular product, using our proprietary VersaTab(TM) delivery technology. We continue to make progress with the project and, together with our strategic partner, Dava Pharmaceuticals Inc., are working diligently towards the filing of an ANDA with the FDA.
Subsequent to the end of the quarter, in April 2013 we announced that Rajiv Khosla RPh, PhD, MBA has been appointed Chief Operating Officer and Chief Scientific Officer of the Company. The succession plan will see Dr. Khosla become CEO and President of IntelGenx on January 1, 2014 and for Dr. Zerbe, the founder, to remain as Chairman of the board of directors and continue to provide expertise in research and development, and manufacturing.
Dr. Khosla has broad experience and credentials including, among other senior positions, five years as Vice President of Business Development at Biovail Corporation, a Canadian pharmaceutical company operating internationally. Whilst there, Dr. Khosla successfully led the transaction process for more than 75 deal opportunities in a variety of therapeutic areas.
He holds a Ph.D. in pharmaceutical science, with a thesis on Oral Drug Delivery Technology; an Executive MBA from the Henley Business School in England, a Bachelor of Pharmacy (Honours) from the University of Nottingham, England and is a registered pharmacist in the UK.
Cash of $2.2 million as at March 31, 2013 improved by $0.1 million compared with cash of $2.1 million as at December 31, 2012.
Accounts receivable decreased by $1.1 million, from $1.3 million as at December 31, 2012 to $0.2 million as at March 31, 2013. Included in this decrease is the receipt of the milestone payment related to the launch of Forfivo XL®.
Revenue of $0.2 million in the first quarter of 2013 consisted of $0.1 million of royalty income and $0.1 million of deferred license revenue, both related to Forfivo XL®. Revenue in the first quarter of 2012 was $0.1 million.
Total expenses decreased from $0.7 million in the first quarter of 2012 to $0.6 million in the first quarter of 2013. The decrease relates primarily to clinical study costs incurred in the first quarter of 2012 that were not repeated in the first quarter of 2013.
The net loss decreased from $0.6 million in the first quarter of 2012 to $0.5 million in the first quarter of 2013. The loss per share was consistent at $0.01 in both the first quarters of 2012 and 2013.
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 indications such as severe depression, hypertension, erectile dysfunction, migraine, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. 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, 2012, 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