SAINT LAURENT, Quebec, Nov. 8, 2012 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx", "the Company") today announced that the Company concluded a pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to its 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 the Company intends 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. The 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.
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.