IntelGenx and RedHill Biopharma Signed License Agreement with Pharmatronic Co.
Thursday, December 15, 2016
IntelGenx Corp., and RedHill Biopharma Ltd., announced the signing of an exclusive license agreement with Pharmatronic Co. ("Pharmatronic Co.") for the commercialization of RIZAPORT® in the Republic of Korea (South Korea). RIZAPORT® is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.
Under the terms of the agreement, RedHill granted Pharmatronic Co. the exclusive rights to register and commercialize RIZAPORT® in South Korea. IntelGenx and RedHill are entitled 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. Further financial terms of the agreement were not disclosed. The initial term of the definitive agreement with Pharmatronic Co. is for ten years from the date of first commercial sale and shall automatically renew for an additional two-year term. Commercial launch in South Korea is estimated to take place in the first quarter of 2019.
"We are most pleased to be entering the Asian market for the first time with Pharmatronic, a Korean organization committed to customer service excellence," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We will be working hard with our partners RedHill and Pharmatronic to bring our innovative product to market for patients in South Korea suffering with migraines. The execution of two commercialization agreements for RIZAPORT® in less than six months demonstrates our relentless execution of strategy to bring our innovative products to the global market."
Mr. Adi Frish, RedHill's Senior VP Business Development & Licensing, said: "We are pleased to enter into our second commercialization agreement for RIZAPORT® and look forward to building a long-term relationship with Pharmatronic Co. This agreement for South Korea follows our recent commercialization agreement with Grupo JUSTE S.A.Q.F for Spain. We continue working diligently together with our partner IntelGenx to bring this unique migraine drug to additional markets and expect to re-submit the RIZAPORT® NDA to the FDA in the first half of 2017."
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 for RIZAPORT®. A first commercialization agreement was signed with Grupo JUSTE S.A.Q.F (Grupo JUSTE) for Spain and additional potential territories and, subsequently, a national Marketing Authorization Application (MAA) for RIZAPORT® was submitted by Grupo JUSTE in Spain under the European DCP.
IntelGenx and RedHill 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.
