The Medicines Company, a global biopharmaceutical company focussed on hospital care, and SciClone Pharmaceuticals, an US based, China focussed specialty pharmaceutical company, announced the establishment of a strategic partnership for two cardiovascular products in China. The partnership includes an agreement granting SciClone a licence and the exclusive rights in China to promote two products of The Medicines Company.
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 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.
“We are excited to collaborate with SciClone as one of the few pharmaceutical companies with an established presence in Chinese hospital cardiac cath-labs. With over 400,000 PCIs performed annually, potentially growing to exceed well over one million annual PCIs in the coming years, China represents a significant growth opportunity for Angiomax,” said Glenn Sblendorio, president and chief financial officer for The Medicines Company. “Cleviprex also represents a differentiated opportunity in the large and growing Chinese anti-hypertensive market.”
“This partnership signals an important commitment of our company to pursue growth opportunities in Asia through partnerships,” said Sanuj Ravindran, MD, Vice President, New Business Ventures for The Medicines Company. “We will continue to seek to structure collaborative deals for the MDCO portfolio in China and other major markets in the Asia Pacific region.”
“We are very excited to add Angiomax and Cleviprex to our product portfolio,” said Hong Zhao, chief executive officer of China Operations for SciClone. “These differentiated products offer significant synergies with our current cardiovascular portfolio and sales and marketing activities. We believe that Angiomax represents an attractive alternative to current treatment options in the large and growing PCI market, with the potential to achieve effectiveness, including reducing bleeding events, especially in high risk patients. Cleviprex also offers potential advantages when compared to conventional intravenous anti-hypertensives, thanks to its rapid onset, short half-life and arterial selectivity.”
Friedhelm Blobel, SciClone’s chief executive officer, added, “China’s rapid socio-economic development, lifestyle changes and aging population are driving the growing incidence rate and significant disease burden of cardiovascular disease in China. We believe Angiomax and Cleviprex represent significant opportunities for SciClone, and have the potential to augment our cardiovascular franchise. We look forward to working with our partner The Medicines Company to bring these important medical advances to patients in need.”
In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina (UA) undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.