UCB-Bioproducts (UCB-Bio) today announced that it will provide commercial quantities of bivalirudin, the active pharmaceutical ingredient (API) for The Medicine Company's (NASDAQ: MDCO) Angiomax™, a thrombin-specific anticoagulant initially indicated for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), which received U.S. Food and Drug Administration (FDA) approval in December 2000.
As part of their collaboration with The Medicines Company, UCB-Bio designed a uniquely scaled process for producing the 20 amino acid optimized natural peptide used in bivalirudin. Following more widely known hormone-like peptides such as Salmon Calcitonin and LH-RH agonists, Angiomax is the second novel, anticoagulant drug on the market to be based on a synthetic peptide.
"We believe the FDA's approval of Angiomax confirms that novel, synthetic peptide-based APIs can be brought to market. And we are delighted to be a strategic partner with The Medicines Company by providing them with clinical materials on time and within budget to meet the timelines of their program," said Alain Scarso, Ph.D and General manager of UCB-Bio.
In addition to the production of bivalirudin, UCB-Bio is responsible for the filing and regulatory support of the Type II drug master file which is a submission to the FDA used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. In this capacity, UCB-Bio has worked in conjunction with The Medicines Company to provide regulatory information and support relating to data on the API filed as a part of its New Drug Application (NDA) for Angiomax.
Currently, UCB-Bio is providing The Medicines Company with bivalirudin for Angiomax for use in two phase III trials for patients with myocardial infarction and angioplasty patients experiencing heparin induced thrombocytopenia. UCB-Bio is recognized as the preferred supplier for commercial quantities for such large patient populations.
UCB-BIO is a global leader in providing peptide contract manufacturing services for pharmaceutical and biotechnology companies. For 30 years the company has provided the industry's widest range of capabilities related to the manufacturing of synthetic peptide-based APIs. Currently, several of these are being developed for a wide variety of applications ranging from in-vivo diagnostic imaging to acute cardiovascular care, osteoporosis, and infectious and neurodegenerative disorders. UCB-Bio continues to provide its clients with innovative process technology and the flexibility and capacity to produce quantities ranging from milligrams to hundreds of kilograms. The company has manufacturing facilities in Europe (Brussels) and the United States (Atlanta), global marketing offices in Cambridge, MA, and regional offices in California and Japan. UCB-Bio is a division of UCB Group, a publicly traded company on the Euronext stock exchange, headquartered in Brussels. For more information on The Medicines Company, go to www.angiomax.com.