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The Medicines Company and SymBio Pharmaceuticals Establish Strategic Partnership for IONSYS® (fentanyl iontophoretic transdermal system) in JapanThe Medicines Company (Nasdaq:MDCO) and SymBio Pharmaceuticals Ltd. (4582:Tokyo), 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 U.S. Food and Drug Administration (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 (News - Alert)) issued a positive opinion recommending marketing authorization for IONSYS. A phase I study for IONSYS targeting healthy Japanese patients has been completed. 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. "This partnership further signals an important commitment of our company to pursue growth opportunities outside the United States through partnerships and to deliver innovation in the management of patients with acute post-operative pain to the Japanese market," said Glenn Sblendorio, President of The Medicines Company. "Through this partnership, IONSYS has the potential to become The Medicines Company's first product to reach patients in Japan." "We are very excited to add IONSYS to our product portfolio. This product has the potential to change the management of pain in the hospital," said Fuminori Yoshida, Chief Executive Officer for SymBio. "We hope to take full advantage of an accelerated path to regulatory approval given that IONSYS has already completed a Phase I study in Japanese patients." About IONSYS® (fentanyl iontophoretic transdermal system) INDICATION IONSYS® (fentanyl iontophoretic transdermal system) CII, contains fentanyl, an opioid agonist. IONSYS is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital. Limitations of Use:
IMPORTANT SAFETY INFORMATION WARNING: HOSPITAL USE ONLY; LIFE-THREATENING RESPIRATORY DEPRESSION; IONSYS REMS; ADDICTION, ABUSE, AND MISUSE; and CYTOCHROME P450 3A4 INTERACTION Life Threatening Respiratory Depression Use of IONSYS may result in potentially life-threatening respiratory depression and death as a result of the active drug, fentanyl. Only the patient should activate IONSYS dosing. Accidental exposure to an intact IONSYS or to the hydrogel component, especially by children, through contact with skin or contact with mucous membranes, can result in a fatal overdose of fentanyl. IONSYS is for use only in patients in the hospital. Discontinue treatment with IONSYS before patients leave the hospital. IONSYS Risk Evaluation and Mitigation Strategy (REMS) Program
Addiction, Abuse, and Misuse
Cytochrome P450 3A4 Interaction The concomitant use of IONSYS with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving IONSYS and any CYP3A4 inhibitor or inducer. Contraindications
Warnings and Precautions
Adverse Reactions Most common (frequency =2%) headache, hypotension, nausea, vomiting, anemia, dizziness, application site reaction-erythema, pruritus, and urinary retention. About The Medicines Company The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care, and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland. The Medicines Company Forward-Looking Statements Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "hopes," and "potential" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether our product candidates will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company or its partners will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, the Company's or its partner's ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC (News - Alert) on August 7, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements. About SymBio SymBio Pharmaceuticals Ltd. was established in March, 2005, by President and CEO, Fuminori Yoshida, who previously served concurrently as Corporate VP of Amgen Inc. and founding President of Amgen Japan. The company's underlying corporate mission is "delivering hope to patients in need" as it aspires to be a leading global biopharmaceutical company dedicated to addressing underserved medical needs.
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