NDA for Rizatriptan Anti-Migraine VersaFilm(TM) to be filed by the end of this month
Saint Laurent, Quebec--(Newsfile Corp. - March 18, 2013) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company") today announced financial results for its fiscal year ended December 31, 2012 and provided an update on operational developments.
"We ended 2012 with cash exceeding $2 million, no debt, and our first FDA-approved product, Forfivo XL®, having been successfully launched in the USA by Edgemont Pharmaceuticals," stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. "As we enter 2013, we have received payment of the $1.0 million milestone invoiced to Edgemont at the end of the fourth quarter of 2012, and we look forward to receiving royalty income from Forfivo XL® whilst we pursue licensing opportunities for the rest of the world. We will also continue to focus our attention on achieving FDA approval of the remaining products in our pipeline, with a 505(b)(2) NDA submission for our anti-migraine VersaFilm product on track to be filed by the end of March 2013, as previously disclosed."
Corporate Development Update
Anti-migraine VersaFilm™ (rizatriptan)
In May 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. The study results indicate that the product is safe, and that the 90% confidence intervals of the three relevant parameters Cmax, AUC(0-t) and AUC(0-infinity) are well within the acceptance range for bioequivalency.
In November 2012 we announced the successful conclusion of a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration related to our VersaFilm™ formulation of Rizatriptan. The purpose of the meeting was to receive confirmation from FDA regarding the adequacy of the clinical, non-clinical and CMC data for our proposed 505(b)(2) NDA submission, which we are on track to file by the end of the first quarter of 2013.
Maxalt-MLT® is a leading branded anti-migraine product manufactured by Merck & Co. Our thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialization agreement with RedHill Biopharma Ltd. using IntelGenx' proprietary immediate release "VersaFilm™" drug delivery technology.
Erectile Dysfunction VersaFilm™ (tadalafil)
Subsequent to the end of the year, in February 2013 we successfully completed a pilot bioequivalence study on our erectile dysfunction VersaFilm™ 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 need for a faster tadalafil 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™ 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™ 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.
The cash balance of $2.1 million as at December 31, 2012 compares with cash of $3.5 million at December 31, 2011. Net funds used in operations totaled $1.6 million in 2012, compared with net funds used of $2.3 million in 2011, and funds used in investing activities totaled $0.3 million and $0.2 million in 2012 and 2011 respectively. Funds generated from financing activities were $0.4 million in 2012 compared with $4.8 million in 2011, including $3.2 million from private placements completed in June 2011.
Accounts receivable of $1.3 million as at December 31, 2012 (December 31, 2011 - $0.3 million) includes an amount of $1.0 million related to the launch of Forfivo XL® that was invoiced to Edgemont Pharmaceuticals in the fourth quarter of 2012. Payment against the invoice was received in February 2013.
Revenue improved from $0.4 million in fiscal 2011 to $1.2 million in 2012, primarily due to the milestone payment of $1.0 million invoiced to Edgemont Pharmaceuticals for the launch of Forfivo XL® in the fourth quarter of 2012.
Total expenses increased from $2.9 million in fiscal 2011 to $3.5 million in 2012. The increase is primarily attributable to additional R&D expenditure of $0.3 million related to costs associated with the technical transfer of activities in preparation of the manufacture of Forfivo XL® and a Product Fee for Forfivo XL® payable to the FDA.
The net loss decreased from $2.5 million in fiscal 2011 to a loss of $2.3 million in 2012, and the loss per share decreased from $0.05 per share in 2011 to $0.04 per share 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, 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