RedHill Biopharma Announces Successful Pre-NDA Meeting with FDA Toward a Filing of a U.S. New Drug Application (NDA) for its RHB-103 Anti-Migraine Oral Thin-Film

TEL AVIV, Israel --(Business Wire)--

RedHill Biopharma Ltd. (TASE: RDHL), an Israeli biopharmaceutical company focusing primarily on development and acquisition of late clinical-stage, patent-protected, new formulations and combinations of existing drugs, reported that on November 7^th, the Company and its co-development partner, IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT), concluded a pre-New Drug Application ("pre-NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to RedHill's RHB-103, a patent protected, oral thin-film formulation of Rizatriptan (the active drug in Merck & Co.'s Maxalt-MLT® orally disintegrating tablets). RHB-103 is based on IntelGenx' proprietary immediate release "VersaFilm" oral thin-film technology for rapid dissolution.

The purpose of the meeting was to discuss the proposed filing of a U.S. new drug application ("NDA") following the successful pivotal bioequivalence study conducted by the Company and IntelGenx with RHB-103 earlier this year.

In view of the positive outcome of the aforementioned pre-NDA meeting with the FDA, RedHill estimates that an NDA will be filed during the first quarter of 2013. RedHill and IntelGenx are currently in advanced preparations of the NDA.

RHB-103 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 Maxalt^® and Maxlt-MLT^® - the reference drug in the RHB-103 pivotal bioequivalence clinical study - exceeded $600 million in 2011.

Dror Ben-Asher, RedHill Biopharma's CEO, commented, "We continue to decisively and diligently execute on the Company's business plan and are looking forward to filing our first New Drug Application in the U.S. - RHB-103. I would like to take this opportunity to thank RedHill's R&D team, and our co-development partners at IntelGenx, for achieving this important milestone with RHB-103."

About RedHill Biopharma Ltd.:

RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development of late clinical-stage, patent protected, new formulations and combinations of existing drugs. The Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a once-daily formulation of a leading oncology support nausea and vomiting prevention drug, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine, a combination therapy for the treatment of Crohn's disease as well as Multiple Sclerosis (MS) disease, and companion diagnostic test for detection of the MAP bacteria, a combination therapy for the treatment of resistant H. pylori bacteria causing ulcers, and an encapsulated formulation for bowel preparation ahead of certain gastro procedures. The Company's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.

This Press Release does not constitute an offer or solicitation to acquire and/or sell the Company's securities or to participate in any investment in the Company. Statements in this Press Release that are not historical facts, including the estimated filing date of the NDA, are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All of these forward-looking statements are based on information currently available to the Company and are subject to risks and uncertainties that may change at any time, including changes in regulatory requirements, changes in our understanding of the results of the meeting with the FDA, and that the preparation time of the NDA may be longer than anticipated, and, therefore, actual results may differ materially from those expected. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors.