US drugmaker The Medicines Company (Nasdaq: MDCO) joined forces with Japanese specialty drug firm SymBio Pharmaceuticals (TYO: 4582) for the commercialization of Ionsys (fentanyl iontophoretic transdermal system) in Japan.
The partnership includes an agreement granting SymBio an exclusive license in Japan to develop and commercialize Ionsys. The product was approved by the US Food and Drug Administration on April 30, 2015, for the short-term management of acute post-operative pain in adult patients requiring opioid analgesia in the hospital. On September 25, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending marketing authorization for Ionsys. A phase I study for Ionsys targeting healthy Japanese patients has been completed.
Deal includes $10 million upfront payment to TMC
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