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     1037  0 Kommentare RedHill Biopharma and IntelGenx Announce RIZAPORT® Commercialization Term Sheet with Pharmatronic Co. for Korea

    • RIZAPORT® (5 mg and 10 mg) was granted marketing approval in Germany under the European Decentralized Procedure (DCP)
    • This binding term sheet for the license of RIZAPORT® in South Korea follows a recent commercialization agreement for Spain with Grupo JUSTE S.A.Q.F, who recently filed a national Marketing Authorization Application (MAA) for RIZAPORT® in Spain
    • RedHill and IntelGenx expect to re-submit the RIZAPORT® U.S. New Drug Application (NDA) to the FDA in the first half of 2017 and subsequently receive a new PDUFA date

    TEL-AVIV, Israel, Sept. 21, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, together with IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, today 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.

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    RedHill Biopharma and IntelGenx Announce RIZAPORT® Commercialization Term Sheet with Pharmatronic Co. for Korea RIZAPORT® (5 mg and 10 mg) was granted marketing approval in Germany under the European Decentralized Procedure (DCP) This binding term sheet for the license of RIZAPORT® in South Korea follows a recent commercialization agreement for Spain with …