RedHill Biopharma Ltd., an Israeli biopharmaceutical company, and IntelGenx Corp., a Canadian drug delivery company focused on oral drug delivery, announced that the Federal Institute for Drugs and Medical Devices of Germany (BfArM) has granted marketing authorization of Rizaport (RHB-103) 5mg and 10mg, an oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.

Over 50 million people in Europe are estimated to be affected by migraines. Approximately 2 million Europeans are prone to migraine attacks every day. The worldwide migraine market is expected to exceed $2 billion in sales in 2016.

The national approval of Rizaport in Germany was granted under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. This authorization is the first national marketing approval of Rizaport. Marketing authorization in Luxemburg, the Concerned Member State, is expected to follow. RedHill and IntelGenx intend to continue to work together to obtain national phase approvals in other European DCP territories.

Dr. Reza Fathi, Ph.D., RedHill's Senior VP R&D, said: "We are very pleased to receive German marketing authorization for Rizaport. This is the first drug in RedHill's advanced pipeline to gain marketing approval, a significant milestone for the Company that reflects our team's commitment and execution capabilities, as well as the successful cooperation with IntelGenx."

Dr Elkan Gamzu, Ph.D., RedHill's Rizaport Product Manager added: "Rizaport 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 US and additional territories to bring this new therapeutic alternative to market."

"The European approval of Rizaport 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 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 the first oral thin film bioequivalent to Maxalt Lingua."

Rizaport, 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 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 population. 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 in the US.  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. RedHill and IntelGenx reported that they believe that FDA approval of the Rizaport™ 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.

Rizaport is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. Rizaport 5mg and 10mg was approved for marketing in Germany in October 2015, under the European Decentralized Procedure. A New Drug Application for Rizaport was also filed with the US FDA in 2013 and a CRL was received in 2014. 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. The worldwide annual sales of triptans were estimated to have exceeded $870 million in 20143. Rizaport is based on IntelGenx's proprietary "VersaFilm" technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract. The administration method of the Rizaport oral thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population.

RedHill Biopharma Ltd. is an emerging Israeli biopharmaceutical company primarily focused on the development of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer.

IntelGenx is a leading drug delivery company focused on the development of innovative products based on its proprietary oral drug delivery technologies.