Saint Laurent, Quebec--(Newsfile Corp. - November 13, 2012) - IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQX: IGXT) ("IntelGenx") today announced financial results for the three and nine month periods ended September 30, 2012 and highlighted recent business developments. All amounts are in U.S. dollars, unless otherwise stated.
“We are very excited that our first FDA-approved product, Forfivo XL®, has been launched in the USA in early October by our partner Edgemont Pharmaceuticals. We believe that Forfivo XL®, as the only single tablet 450mg bupropion HCl available in the U.S., will be a valuable tool for physicians in their management of patients with major depressive disorders,” stated Dr. Horst G. Zerbe, President and CEO of IntelGenx. “In addition, following the positive pivotal bioequivalence results announced last quarter for our anti-migraine VersaFilm™ product, we are pleased to confirm that a recent pre-NDA meeting with FDA confirmed that we remain on track to file our 505(b)(2) NDA submission in the first quarter of 2013. This product, along with our Par project, is our top pipeline priority for the immediate future.”
Subsequent to the end of the third quarter, on October 9, 2012 we announced the commercial launch of Forfivo XL® in the USA.
Forfivo XL® is indicated for the treatment of Major Depressive Disorder (MDD) and is the only extended-release bupropion HCl product to provide a once-daily, 450mg dose in a single tablet. The active ingredient in Forfivo XL is bupropion, the same active ingredient used in the well-known antidepressant product: Wellbutrin XL®. Until now, patients in the US requiring a 450mg dose of bupropion HCl have been taking multiple tablets to achieve their 450mg dose requirement. With Forfivo XL® now available in the US, these patients can simplify their dosing regimen to a single Forfivo XL tablet, once-daily.
Forfivo XL® was developed by IntelGenx and is the Company's first U.S. Food and Drug Administration (“FDA”) approved product, approved by the FDA on November 10, 2011. Forfivo XL® is being marketed in the United States under the terms of a license agreement between IntelGenx and Edgemont Pharmaceuticals. The commercialization of Forfivo XL® triggers launch-related milestone payments for IntelGenx of up to $4.0 million, and additional milestones upon achieving certain sales and exclusivity targets of up to a further $23.5 million. IntelGenx will also receive tiered double-digit royalties on net sales of Forfivo XL®.
Anti-migraine VersaFilm™ (rizatriptan)
Subsequent to the end of the third quarter, on November 8, 2012 we announced the successful conclusion of a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to our novel oral thin-film formulation of Rizatriptan, the active drug in Maxalt-MLT® orally disintegrating tablets.
The purpose of the meeting was to confirm the adequacy of the clinical, non-clinical and CMC data for the Company's proposed 505(b)(2) NDA submission, which we intend to file in the first quarter of 2013, as previously announced.
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. Our thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (TASE:RDHL) using IntelGenx' proprietary immediate release "VersaFilm™" drug delivery technology.
We had cash of $2.8 million as at September 30, 2012, which represents a decrease of approximately $0.7 million from our cash position of $3.5 million as at December 31, 2011 and is $0.4 million below our cash position of $3.2 million at the end of June 2011. In the first nine months of 2012 we used cash of $1.8 million and $0.2 million for operating activities and investments respectively, which was partly offset by the generation of $1.0 million in cash from changes in assets and liabilities, together with $0.3 million in cash from the exercise of warrants.
Revenue and other income was $0.1 million in the first nine months of 2012, compared with $0.1 million in the first nine months of 2011.
Total expenses were $2.0 million in the first nine months of 2012, compared with $1.9 million in the same period of 2011.
The net loss was $1.8 million in the first nine months of 2012, compared with $1.8 million in the first nine months of 2011, and the basic and diluted loss per share of $0.04 in the first nine months of 2012 is equal to the basic and diluted loss per share in the same period of 2011.
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 atwww.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