RedHill Biopharma, IntelGenx Provide Update on FDA's Ongoing Review of NDA for RHB-103 Oral Migraine Film

RedHill Biopharma Ltd.

("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, together with IntelGenx Corp. ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the RHB-103 New Drug Application ("NDA") and has requested further clarifications. RHB-103 is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines. RedHill and IntelGenx (the "Companies") reported on March 3, 2014 that they had submitted their response to the FDA's CRL for the RHB-103 NDA, which had raised questions primarily related to Chemistry, Manufacturing and Controls (CMC). In response, the FDA has requested from the Companies additional CMC data, which the Companies believe they can supply within several weeks based on available information. The Companies further report that a supplier of raw material for RHB-103 is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to RHB-103. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions. The Companies believe that FDA approval of the RHB-103 NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, RedHill and IntelGenx continue to work with the FDA in order to submit all the data requested and will provide an update as and when applicable. About RHB-103: RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131. RHB-103 is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the RHB-103 oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.