ENP Newswire - 16 May 2014
Release date- 14052014 - Saint Laurent, Quebec - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) today announced financial results for the three months ended March 31, 2014 and provided an update on corporate developments.
All amounts are in U.S. Dollars, unless otherwise stated.
Corporate Development Update
Par Pharmaceutical, Inc.
On January 13, 2014 we announced the execution of a second development and commercialization agreement with Par Pharmaceutical, Inc. ('Par') for two new products utilizing our proprietary oral drug delivery platforms.
Under the terms of the agreement, Par has obtained certain exclusive rights to market and sell our products in the USA. In exchange we will receive upfront and milestone payments, together with a share of the profits upon commercialization. In accordance with confidentiality clauses contained in the agreement, the specifics of the products and financial terms remain confidential.
Anti-migraine VersaFilm product
On February 4, 2014 we, together with our co-development partner RedHill Biopharma Ltd. ('RedHill'), announced receipt of a Complete Response Letter ('CRL') from the U.S. Food and Drug Administration ('FDA') regarding the New Drug Application ('NDA') for our VersaFilm product for the treatment of acute migraines. The anti-migraine VersaFilm product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt.
A CRL is issued by the FDA'sCenter for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm product primarily relate to Chemistry, Manufacturing and Controls ('CMC') and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.
On March 3, 2014 we, together with RedHill, announced the submission of a response to the FDA's CRL and on April 24, 2014IntelGenx and RedHill (the 'Companies'), reported that the FDA had acknowledged receipt of our response and has requested additional CMC data, which the Companies believe they can supply within several weeks based on available information.
The Companies further reported that a supplier of raw material for the anti-migraine VersaFilm product is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to our anti-migraine VersaFilm product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions.
The Companies believe that FDA approval of the anti-migraine VersaFilm product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, IntelGenx and RedHill will continue to work with the FDA in order to submit all the data requested, and will provide an update as and when applicable.
On April 28, 2014 the Companies announced the commencement of a comparative bioavailability clinical study comparing the anti-migraine VersaFilm product to the European reference drug. The study is intended to support the planned submission of a European Marketing Authorization Application ('MAA') and follows a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices ('BfArM') announced by RedHill in November 2013.
This single-dose, crossover, comparative bioavailability study includes 26 healthy volunteers and is intended to evaluate and compare the relative bioavailability and to assess the bioequivalence of the anti-migraine VersaFilm product and the reference drug, Maxalt lingua, marketed in Germany by Merck Sharp & Dohme GmbH.
Results of the bioavailability study are anticipated by June 2014. Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with the anti-migraine VersaFilm product, the Companies plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure ('MRP').
Erectile Dysfunction VersaFilm product
On February 24, 2014 we announced the completion of a pilot biostudy with our proprietary VersaFilm tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug ('RLD') tadalafil product.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.
Government Funding for CNS VersaFilm product
On April 30, 2014 we announced financial support from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP). In addition to advisory services and technological expertise, the funding provided by NRC-IRAP will support further development of a product for the treatment of central nervous system (CNS) diseases and disorders. The product will be based upon our proprietary, oral thin film, VersaFilm, technology.
In order to maintain our competitive advantage, no specific details related to this project are being disclosed at this time.
U.S. patent allowances
On February 26, 2014 we announced receipt of a Notice of Allowance ('NOA') from the United States Patent and Trademark Office ('USPTO') for U.S. Patent Application Serial No. 11/647,033 entitled 'Multilayer tablet' which covers the technology used in our hypertension product currently under development.
A second NOA has been received for U.S. Patent Application Serial No. 11/782,838 entitled 'Controlled-release pharmaceutical tablets' which is related to the drug delivery technology used in Forfivo XL, our first FDA-approved product currently commercialized in the U.S. These two NOA's conclude the examination of each U.S. patent application and will result in the issuance of two U.S. patents after administrative processes are completed.
On April 16, 2014 we announced receipt of a further NOA from the USPTO for U.S. Patent Application Serial No. 12/836,810 entitled 'Oral mucoadhesive dosage form' which covers IntelGenx' proprietary AdVersa mucoadhesive drug delivery technology. This NOA concludes the examination of the U.S. patent application and will result in the issuance of a U.S. patent after the administrative process is completed.
Cash on hand at March 31, 2014 increased to $5.2 million and compares with a cash balance of $5.0 million as at December 31, 2013. The increase in cash on hand at the end of Q1, 2014 relates to net cash provided by financing activities of $1.1 million (Q1, 2013 - $0.2 million), partly offset by net cash used in operating activities of $0.6 million (Q1, 2013 - $0.0 million), net cash used in investing activities of $0.1 million (Q1, 2013 - $0.1 million), and an unrealized foreign exchange loss of $0.2 million (Q1, 2013 - $0.0 million). The net cash provided by financing activities in Q1, 2014 consists of approximately $1.1 million in proceeds received from the exercise of warrants.
Revenue of $222 thousand during the quarter ended March 31, 2014 (Q1, 2013 - $157 thousand) primarily relates to revenue generated by Forfivo XL, our first FDA-approved product.
Total expenses in the first quarter of 2014 were $664 thousand compared with $643 thousand in the same period of 2013. The increase in R&D expenses relates to the costs of a pilot clinical study for our VersaFilm product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug tadalafil product, partly offset by a reduction in R&D staff salaries.
The net loss decreased from $486 thousand in Q1, 2013 to a loss of $442 thousand in Q1, 2014. The loss per share was $0.01 in Q1, 2014 and $0.01 in Q1, 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, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products.
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, 2013, 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.
Paul A. Simmons
Chief Financial Officer
IntelGenx Technologies Corp.
Tel: +1 514-331-7440
Fax: +1 514-331-0436