Saint Laurent, Quebec--(Newsfile Corp. - November 8, 2013) - IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx") today announced financial results for the three and nine months ended September 30, 2013 and provided an update on operational developments. All amounts are in U.S. dollars, unless otherwise stated.
Corporate Development Update
ANDA for Buprenorphine/Naloxone Sublingual Film Product for the Treatment of Opiate Addiction:
On July 22, 2013 we announced that an Abbreviated New Drug Application ("ANDA") has been submitted to the U.S. Food and Drug Administration ("FDA") for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, indicated for maintenance treatment of opioid dependence. The ANDA was filed by our U.S. based co-development and commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film.
According to IMS Health, U.S. retail sales of Suboxone® Sublingual Film were approximately $1.5 billion in 2012.
On August 26, 2013 we announced that, in response to filing of the ANDA, we were named as a codefendant in a lawsuit pursuant to Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and 8,017,150, each of which relate to Suboxone® Sublingual Film. We believe the ANDA product does not infringe those or any other patents, and will vigorously defend ourselves in this matter. Since Paragraph IV litigation is a regular part of the ANDA process, we do not expect any unanticipated impact on our already planned development schedule. In accordance with the terms of the co-development and commercialization agreement, the costs of defending this litigation will be borne by Par Pharmaceutical Inc.
On October 8, 2013 we received confirmation that Actavis plc has filed an ANDA with the FDA seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Film 2 mg/0.5 mg and 8 mg/2 mg. Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited and MonoSol Rx, LLC filed suit against Actavis on October 8, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, including a submission date listed on FDA's Paragraph IV Patent Certifications web site that is consistent with the date of Actavis' ANDA filing, Actavis believes it may be a "first applicant" to file an ANDA for a generic version of Suboxone® Sublingual Film and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
NDA for Anti-Migraine VersaFilm™ Oral Film Product:
On June 18, 2013 we announced that the FDA has assigned a Prescription Drug User Fee Act ("PDUFA") action date of February 3, 2014 for the review of the our New Drug Application ("NDA") for the marketing approval of our anti-migraine VersaFilm™ oral film product. We had previously announced that, together with our co-development partner RedHill Biopharma Ltd ("RedHill"), we had submitted a 505(b)(2) NDA to the FDA for a novel, oral thin-film formulation, based on our proprietary VersaFilm™ technology containing Rizatriptan, the active drug in Merck & Co ("Merck") Maxalt-MLT® orally disintegrating tablets. According to Merck's most recent annual report, sales of Maxalt® were $638 million in 2012. The FDA confirmed that our application is sufficiently complete to permit a substantive review in accordance with the FDA's "standard" classification process.
On August 22, 2013 we announced receipt of a Paragraph IV Certification Letter from Wockhardt Bio AG, advising of the submission of an ANDA to the FDA requesting authorization to manufacture and market generic versions of Forfivo XL® 450 mg capsules in the United States.
IntelGenx intends to vigorously enforce its intellectual property rights for Forfivo XL® and will pursue all available legal and regulatory pathways in defense of Forfivo XL®, which is currently protected by an issued patent listed in the FDA's Approved Drug Products List (Orange Book).
Cash and cash equivalents improved to $2.6 million as at September 30, 2013 compared with $2.3 million as at June 30, 2013 and $2.1 million as at December 31, 2012. In the third quarter of 2013 we received $0.7 million from the exercise of warrants and we benefitted from the positive impact of foreign exchange on cash of $0.1 million. This was partly offset with cash used by operating activities of $0.4 million and cash used in investing activities of $0.1 million. Year-to-date, we received $1.5 million from the exercise of warrants and stock options, which was partly offset with cash used by operating activities of $0.7 million and cash used in investing activities of $0.3 million.
Revenue of $0.8 million in the first nine months of 2013 represents a significant increase compared with $0.1 million in the same period of the previous year and consists of $0.5 million related to the achievement of development milestones for our anti-migraine and opiate addiction products, together with $0.1 million of royalty income and $0.2 million of deferred license revenue, both related to Forfivo XL®.
Total expenses decreased from $2.0 million in the first nine months of 2012 to $1.8 million in the first nine months of 2013. The decrease relates primarily to clinical study costs incurred in 2012 that were not repeated in 2013, together with the reversal of costs accrued in 2012 for the technical transfer of activities in preparation for manufacturing of Forfivo XL™, partly offset by increased staff costs. Total expenses were $0.7 million in the third quarter of 2012 and $0.7 million in the third quarter of 2013.
The net loss decreased from $1.9 million in the first nine months of 2012 to $1.0 million in the first nine months of 2013, representing an improvement of $0.9 million, or 48%. In the third quarter of 2013 we recorded a net loss of $0.6 million, compared with a net loss of $0.7 million in the same period of the previous year.
The loss per share improved from $0.04 in the first nine months of 2012 to a loss of $0.02 in the first nine months of 2013. In the three months ended September 30, 2013 the loss per share was $0.01, compared with a loss per share of $0.01 in the same period of 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 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