UCB-Bioproducts to Provide Active Pharmaceutical Ingredient For FDA Approved Angiomax 'Bivalirudin'.Business Editors and Health/Medical Writers BRUSSELS, Belgium--(BW HealthWire)--Jan. 31, 2001 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(TM), a thrombin-specific anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). initially indicated for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ), which received U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption. and LH-RH LH-RH luteinizing hormone. LH-RH luteinizing hormone-releasing hormone (gonadotropin releasing hormone). 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 Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) 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. About UCB-Bioproducts 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 publicly traded company A company whose shares of common stock are held by the public and are available for purchase by investors. The shares of publicly traded firms are bought and sold on the organized exchanges or in the over-the-counter market. on the Euronext stock exchange, headquartered in Brussels. For more information on The Medicines Company, go to www.angiomax.com. |
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