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RedHill Biopharma Submits New Drug Application To U.S. FDA For RHB-103 Anti-Migraine Oral Thin Film

TEL-AVIV, Israel, March 27, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, today announced that the Company and its co-development partner, IntelGenx Corp. ("IntelGenx"), have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of RHB-103, a proprietary, oral thin film formulation of rizatriptan, a leading drug for the treatment of acute migraine.

The NDA was submitted under a 505(b)(2) regulatory path, following a positive pre-NDA meeting with the FDA and is supported by a successful bioequivalence clinical trial that demonstrated the required FDA criteria for therapeutic equivalence between the soluble oral film of RHB-103 and Merck & Co.'s Maxalt MLT ®.

RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1 agonist and the active drug in Merck & Co.'s Maxalt ® drugs. Rizatriptan is considered one of the most effective oral triptans - a class of molecules that constrict blood vessels in the brain in order to relieve swelling and other migraine symptoms. The worldwide market of triptans was estimated at approximately $2.1 billion in 2011 1, of which the worldwide direct sales of Merck & Co.'s rizatriptan-based drugs exceeded $600 million 2.

RHB-103 is based on IntelGenx' proprietary "VersaFilm TM" technology. The RHB-103 thin film strip dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream.

"We are very pleased with the submission of the NDA for RHB-103. It is our first NDA and an important milestone for RedHill and IntelGenx, as it brings us one step closer to making this attractive thin film rizatriptan drug available for migraine patients in need," said Elkan Gamzu, RedHill's RHB-103 Product Manager. "RedHill's RHB-103 oral thin film is characterized by rapid dissolution, ease of use, pleasant flavoring, and the ability to administer without water, all of which we believe are important for patients who suffer from migraines."

RedHill further reported on February 25, 2013 of its plan to submit a second NDA in the fourth quarter of 2013, for the U.S. marketing approval of RHB-102, a patent protected, oral, extended-release (24 hours) formulation of ondansetron for the prevention of nausea and vomiting in cancer patients. The RHB-102 planned NDA submission follows a successful bioavailability trial, as well as a recent Type B meeting with the FDA.

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