RedHill Biopharma and IntelGenx Submit New Drug Application to FDA for RIZAPORT® for Migraines - Seite 2

If the RIZAPORT^® NDA resubmission is deemed complete and permits a full review by the FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to be set by the FDA for the first half of 2018.

Reza Fathi, PhD, RedHill's Senior VP Research & Development, said: "We are very pleased with the resubmission of the U.S. NDA for RIZAPORT^®, which follows the marketing authorization received for RIZAPORT^® in Germany and Luxembourg under the European Decentralized Procedure. Our efforts are focused on commercializing RIZAPORT^® through partners in the U.S., Europe and other territories in the near future, and we are continuing the dialogue with potential partners."

"This resubmission of the RIZAPORT^® 505(b)(2) NDA is an important milestone for IntelGenx," commented Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We look forward to continuing to work with the FDA as we seek to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."

RIZAPORT^® was granted marketing authorization in Germany and in Luxembourg on the basis of the European Decentralized Procedure (DCP). A national Marketing Authorization Application (MAA) has been submitted for RIZAPORT® in Spain. Under the European DCP, marketing authorization approval of RIZAPORT^® in additional European countries is subject to a separate procedure to obtain additional national marketing authorizations in each country. A first commercialization agreement for RIZAPORT^®was signed with Grupo JUSTE S.A.Q.F. (now Exeltis Healthcare, S.L.) for Spain, and a second commercialization agreement for RIZAPORT^® was signed with Pharmatronic Co. for South Korea.

About RIZAPORT^® (RHB-103):    
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^® 5 mg and 10 mg were approved for marketing in Germany in October 2015 and in Luxembourg in April 2017 under the European Decentralized Procedure. A New Drug Application for RIZAPORT^® was resubmitted to the U.S. FDA in October 2017. RedHill entered into licensing agreements to commercialize RIZAPORT^® in Spain (with with Grupo JUSTE S.A.Q.F.) and in South Korea (with Pharmatronic Co.). Rizatriptan is considered to be 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. RIZAPORT^® is based on IntelGenx's proprietary VersaFilm^(TM)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 soluble 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 migraine patients, specifically for patients who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population¹ and patients suffering from dysphagia (difficulty swallowing)¹.