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First Patients Dosed with Amgen's AMG 162 In Phase 3 Studies for Postmenopausal Osteoporosis and Treatment-Induced Bone Loss
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug. 10, 2004--Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the first patients have been dosed in two pivotal Phase 3 trials of AMG 162, the company's fully human monoclonal antibody being investigated for potential use in postmenopausal osteoporosis and treatment-induced bone loss (TIBL).
AMG 162 is an investigational, fully human monoclonal antibody that specifically binds to and inhibits RANK Ligand, the primary mediator of bone resorption. Amgen scientists have confirmed that RANK Ligand is the protein responsible for activating osteoclasts, the cells that break down bone. Excessive RANK Ligand has been linked as the primary cause of a broad range of bone loss conditions including osteoporosis, treatment-induced bone loss, bone erosions in rheumatoid arthritis (RA), and bone metastases, all of which are being investigated by Amgen. AMG 162 is being investigated for its impact on RANK Ligand and the potential to protect against bone loss.
"Many different factors can lead to bone loss, but they all converge on the RANK Ligand pathway," said Beth Seidenberg, M.D., chief medical officer and senior vice president of global development, Amgen. "In earlier trials, AMG 162 has demonstrated that it is a potent and fast-acting inhibitor of osteoclasts which may impact a number of bone loss conditions; we are pleased to be simultaneously moving a potentially important therapeutic into pivotal studies in two distinct diseases."
Osteoporosis is a disease that causes bones to become brittle and susceptible to fracture. According to the International Osteoporosis Foundation, approximately 200 million women worldwide currently suffer from osteoporosis. Of those, nearly half will experience a related fracture that may significantly limit mobility, preventing an active and independent lifestyle, or that may even shorten lifespan.
About Treatment-Induced Bone Loss
Treatment-induced bone loss (TIBL) includes bone loss associated with the use of glucocorticoids, immunosuppressives and hormone ablative therapies. The prevalence of TIBL in the U.S. is estimated to be around 290,000, however only a small fraction of these patients receive treatment.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
Forward Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2003, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks Andrea Rothschild, 805-447-4587 (media) Laura Biswas, 805-447-1060 (investors) SOURCE: Amgen