Date: 2014-12-18
Type of information: Licensing agreement
Compound: Angiomax® (bivalirudin), Cleviprex® (clevidipine)
Company: The Medicines Company (USA - NJ) SciClone Pharmaceuticals (USA - CA, China)
Therapeutic area: Cardiovascular diseases
Type agreement: licensing commercialisation
Action mechanism: anticoagulant/thrombin inhibitor/hirudin derivative. Angiomax® (bivalirudin) is an anticoagulant indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. calcium channel blocker. Cleviprex® (clevidipine) is a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or desirable.
Disease: patients undergoing percutaneous coronary intervention (PCI), reduction of blood pressure
Details: * On December 18, 2014, The Medicines Company, a global biopharmaceutical company focused on hospital care, and SciClone Pharmaceuticals, a U.S. based, China focused specialty pharmaceutical company, announced the establishment of a strategic partnership for two cardiovascular products in China. The partnership includes an agreement granting SciClone a license and the exclusive rights in China to promote two products of The Medicines Company:Angiomax® (bivalirudin) and Cleviprex® (clevidipine) Angiomax® (bivalirudin) for Injection, an anticoagulant indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. A Phase 3 registration trial was completed in China and is currently under review by the China Food and Drug Administration (CFDA) for marketing approval. Cleviprex® (clevidipine) Injectable Emulsion, a third-generation dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or desirable. The clinical trial application (CTA) for China was filed in 2013.
Under the terms of the agreement, SciClone will be responsible for all aspects of commercialization, including pre- and post-launch activities, for both products in the China market (excluding Hong Kong and Macau). SciClone has also agreed to assist in the China registration process for both products.
Financial terms: Financial terms of the agreement, in addition to net sales royalties payable to The Medicines Company, include the following additional payments to The Medicines Company: an upfront payment; a product support services fee; and regulatory/commercial success milestone payments of up to an aggregate of $50.5 million.
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