RedHill Biopharma Ltd. (TASE: RDHL), an emerging Israeli biopharmaceutical company focusing primarily on development of late clinical-stage (Phase II/III), patent protected, new formulations and combinations of existing drugs, announces positive results in a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine. RedHill has exclusive world-wide rights and is developing RHB-103 with its Canadian co-development partner IntelGenx, Corp. (TSX: IGX)(OTCBB: IGXT).
Analysis of the results demonstrates that the trial met its specified endpoints and FDA's criteria, in all parameters for bioequivalence, between RedHill's RHB-103 oral thin-film, and Merck & Co.'s Maxalt-MLTR, a leading, approved, migraine treatment, based on Rizatriptan, a 5-HT1 receptor agonist drug.
RedHill awaits the final report of the clinical trial results, subject to which the Company and IntelGenx intend to file with the FDA a New Drug Application for a US marketing approval (NDA).
The trial was conducted in Canada following discussions with the FDA and under a CTA (Clinical Trial Application) approval from Health Canada.
RHB-103 is based on IntelGenx' proprietary immediate release VersaFilm oral thin-film technology for rapid dissolution, and is targeting a significant segment of the migraine market - namely the family of triptan migraine drugs - estimated at approximately $2 billion in 2011. The world-wide sales of Merck & Co.'s Rizatriptan drugs, under their various names, including MaxaltR and Maxalt-MLTR - the reference drug in the RHB-103 pivotal clinical trial - exceeded $600 million in 2011.
Elkan Gamzu PhD, RedHill's RHB-103 Product Manager stated today: "We are very pleased with the success of the RHB-103 pivotal trial. The results were achieved thanks to the significant development activities and cooperation with our Canadian partner, IntelGenx. The positive clinical trial results, coupled with RHB-103's unique delivery - a rapidly dissolving oral thin-film - may prove to be a significant competitive advantage in the large market for migraine treatments, estimated in billions.
Dror Ben Asher, RedHill's CEO, added: "RedHill's team continues to diligently and decisively execute on the Company's business plan. Today's announcement follows last month's successful pivotal bioequivalence trial results with yet another RedHill drug, RHB-102 for the prevention of nausea and vomiting in cancer patients. In accordance with its strategic plans, RedHill intends to seek marketing approval for these two drugs in the US, as well as explore commercialization through partnerships with pharmaceutical companies who have strong commercial capabilities. I would like to take this opportunity to thank our R&D team for reaching this important milestone with RHB-103."
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