Date: 2015-10-06
Type of information: Licensing agreement
Compound: Ionsys® (fentanyl iontophoretic transdermal system)
Company: The Medicines Company (USA - NJ) SymBio Pharmaceuticals (Japan)
Therapeutic area: CNS diseases
Type agreement: licensing development commercialisation
Action mechanism: opioid. Ionsys® contains the opioid fentanyl and is a compact, needle-free, pre-programmed system that is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital. Ionsys® is only for use in patients who are alert enough and have adequate cognitive ability to understand the directions for use.
Disease: post-operative pain in adult patients requiring opioid analgesia in the hospital
Details: * On October 6, 2015, The Medicines Company and SymBio Pharmaceuticals, a Tokyo based specialty pharmaceutical company, today announced the establishment of a strategic partnership for Ionsys® (fentanyl iontophoretic transdermal system) in Japan. The partnership includes an agreement granting SymBio an exclusive license in Japan to develop and commercialize Ionsys®. Ionsys® was approved by the FDA 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 (EMA) issued a positive opinion recommending marketing authorization for Ionsys®. A phase I study for Ionsys® targeting healthy Japanese patients has been completed.
Financial terms: Financial terms of the agreement, in addition to net sales royalties payable to The Medicines Company, include a $10 million upfront payment and certain regulatory and commercial milestones.
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