IntelGenx (IGXT) Submits New Drug Application for Anti-Migraine VersaFilm(TM)

SAINT LAURENT, Quebec, March 27, 2013 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx" or the "Company"), a Canadian drug delivery company focusing on oral drug delivery, today announced that, together with its co-development partner RedHill Biopharma ("RedHill"), it has submitted a 505(b)(2) New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for the Company's anti-migraine oral film product, a novel oral thin-film formulation based on its proprietary VersaFilm(TM) technology containing Rizatriptan, the active drug in Merck's Maxalt-MLT(R) orally disintegrating tablets.
The company had previously announced a successful a pre-NDA meeting with the FDA following the successful completion of a bioequivalency study demonstrating that its oral film product is bioequivalent with Maxalt MLT(R), a leading branded anti-migraine product manufactured by Merck & Co. According to Merck's most recent annual report, sales of Maxalt(R) were $638 million in 2012. The thin-film formulation of Rizatriptan has been developed in accordance with the co-development and commercialisation agreement with RedHill Biopharma Ltd. (RDHL) (RDHL) using IntelGenx' proprietary immediate release "VersaFilm(TM)" drug delivery technology.
IntelGenx' orally disintegrating film consists of a thin (30 -- 50 um) polymeric film which disintegrates rapidly upon oral administration, thereby releasing the active drug Rizatriptan and making it available for rapid absorption. The film does not require water for administration.