Amgen submits NDA to FDA for agent to treat disease associated with CHD.Amgen, Inc., Thousand Oaks, CA, has filed a 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 ) with the US 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. ) for Cinacalcet HCI, a first-in-class oral calcimimetic agent, licensed from NPS Pharmaceuticals, Inc. Cinacalcet HCI is currently being investigated for the treatment of secondary hyperparathyroidism (SHPT SHPT Senior Health Physics Technician ) associated with chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is (CHD CHD coronary heart disease. ChD abbr. Latin Chirurgiae Doctor (Doctor of Surgery) CHD, n.pr See disease, coronary heart. CHD canine hip dysplasia. ). Amgen says Cinacalcet HCI represents a potentially significant advance in the treatment of CHD patients diagnosed with SHPT, a common yet serious metabolic disorder where parathyroid hormone levels are elevated. Patients with the disease can suffer from bone disease, bone pain and fractures, soft tissue calcification, vascular calcification and cardiovascular complications. Amgen also announced it has signed a multifaceted agreement with Biovitrum AB, Stockholm Sweden, under which Amgen receives exclusive rights to develop and commercialize Biovitrum's small molecule 11b-HSD1 enzyme inhibitors for the treatment of metabolic disorders and certain other medical disorders. The company says the most advanced compound included in the agreement is BVT.3498, currently in Phase IIa clinical trials for type 2 diabetes type 2 diabetes n. See diabetes mellitus. , a disease which currently affects 160 million people worldwide. Amgen will make an upfront payment of $86.5 million and will fund and conduct all further development and commercialization activities in the licensed territory, which includes North and South America, the European Union, Australia and New Zealand. Contact: Sabrina Johnson - (805) 447-4587, Web site: www.amgen.com; Smikael Widell, Biovitrum - +46 8 697 20 85, Web site: www.biovitrum.com |
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