RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT(TM) (RHB-103) for Migraines - Seite 2

Dr. Elkan Gamzu, Ph.D., RedHill's RIZAPORT^(TM) Product Manager added: "RIZAPORT^(TM) is an innovative new oral thin film formulation of rizatriptan, potentially benefiting many migraine patients who suffer from migraine related nausea, due to its rapid dissolution, pleasant flavor and ease of use. RedHill continues to advance its activities to secure commercialization partners in Europe, the U.S. and additional territories to bring this new therapeutic alternative to market."

"The European approval of RIZAPORT^(TM) is an important milestone achieved by IntelGenx and RedHill which reflects our team's strong capabilities as partners," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We are committed to bringing RIZAPORT^(TM) to market as soon as possible, as we believe it will be a potentially beneficial treatment for patients suffering from migraines. This approval will make RIZAPORT^(TM) the first oral thin film bioequivalent to Maxalt^® Lingua."

RIZAPORT^(TM), an oral thin film formulation of rizatriptan for the treatment of acute migraines, offers a potentially attractive therapeutic alternative for many migraine patients. The RIZAPORT^(TM) oral thin film has a pleasant taste and dissolves rapidly in the mouth, without the need for water. It is a therapeutic alternative for patients suffering from dysphagia (difficulty swallowing), and patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population². Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms.

RedHill and IntelGenx submitted a New Drug Application (NDA) to the FDA in 2013 seeking marketing approval of RIZAPORT^(TM) in the U.S. In 2014, the companies received a complete response letter (CRL) from the FDA which raised questions primarily related to CMC. It is noted that no deficiency was raised relating to the safety or bio-equivalence data of RIZAPORT^(TM). RedHill and IntelGenx reported that they believe that FDA approval of the RIZAPORT^(TM) NDA is subject to the satisfactory resolution of the remaining CMC questions. RedHill and IntelGenx continue their cooperative effort to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.