RedHill Biopharma (RDHL), IntelGenx Enters RIZAPORT Licensing Agreement for Korea

September 21, 2016 8:01 AM EDT

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RedHill Biopharma Ltd. (Nasdaq: RDHL), together with IntelGenx Corp., announced that they have entered into a binding term sheet with Pharmatronic Co. granting Pharmatronic Co. the exclusive license to commercialize RIZAPORT in the Republic of Korea (South Korea). RIZAPORT® is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.

Subject to satisfaction of remaining conditions, the parties will endeavor to enter into a definitive agreement within 60 days of the execution of the term sheet.

Pursuant to the signing of a definitive agreement, RedHill will grant Pharmatronic Co. the exclusive rights to register and commercialize RIZAPORT® in South Korea. Under the term sheet, RedHill and IntelGenx are to receive an upfront payment and will be eligible to receive additional milestone payments upon achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Financial terms of the term sheet were not disclosed. The initial term of the definitive agreement is expected to be ten years from the date of first commercial sale with an automatic renewal of an additional two years. Commercial launch in South Korea is estimated to take place in the first quarter of 2019.

Mr. Adi Frish, RedHill’s Senior VP Business Development & Licensing, said: “We are very pleased to enter into this term sheet with Pharmatronic Co. This is potentially the second territorial license for the commercialization of RIZAPORT®, following the license agreement with Grupo JUSTE for Spain, where a marketing application for RIZAPORT® has recently been submitted. We continue to work diligently to maximize the worldwide potential of this unique migraine drug and are in discussions with multiple potential commercialization partners. Pharmatronic Co. holds a growing portfolio of neurology-focused drugs and is experienced in commercializing migraine products in South Korea. With its unique dissolvable oral thin film delivery form and pleasant flavoring, we are confident that RIZAPORT® should be a welcomed therapeutic alternative for many migraine patients in Korea.”

RIZAPORT® (5 mg and 10 mg) was granted marketing authorization by the Federal Institute for Drugs and Medical Devices of Germany (BfArM) under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State for other European Union (EU) countries. This authorization was the first national marketing approval of RIZAPORT® and a first commercialization agreement was recently signed with Grupo JUSTE S.A.Q.F for Spain and additional potential territories. A national Marketing Authorization Application (MAA) for RIZAPORT® was recently submitted by Grupo JUSTE S.A.Q.F in Spain under the European DCP.

RedHill and IntelGenx expect to re-submit the RIZAPORT® New Drug Application (NDA) to the FDA in the first half of 2017 and subsequently receive a new PDUFA (Prescription Drug User Fee Act) date and are currently in discussions with potential commercialization partners for the U.S. market.

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