By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Amgen Inc. (AMGN) has applied for U.S. marketing approval for its lead pipeline drug, bone treatment denosumab, to the Food and Drug Administration.
The Thousand Oaks, Calif.-based biotech giant is seeking to sell the drug to treat and prevent postmenopausal osteoporosis in women, and bone loss in patients undergoing hormone therapy to treat either prostate or breast cancer.
The drug is seen as crucial to Amgen's future growth as sales growth of its anemia franchise - Aranesp and Enbrel - evaporated last year when studies showed a link to a risk of cardiovascular disease, cancer progression and death. If approved, Wall Street analysts expect the drugs to add billions to Amgen's revenue, which came in at $14.3 billion in 2007.
The denosumab submission contains data from six Phase III trials involving more than 11,000 patients. The company said it expects to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for the same uses.
Amgen is expecting late-stage data next year on denosumab's use in treating in advanced cancer that has spread to the bone and hopes to eventually file for approval in that indication.
The filing comes within the timeline projected by the company last month, when it reiterated that it is in talks to sell denosumab with a partner, but it may do so only for overseas sales and then sell the drug itself in the U.S.
Some expect Amgen to enlist a major pharmaceutical company to help sell denosumab use to primary-care physicians, an area in which Amgen has little experience.
The osteoporosis market is competitive and dominated by Merck & Co.'s (MRK) Fosamax, which became available in cheaper generic form in February.
Amgen is hoping denosumab's convenience will attract patients who aren't successful with Fosamax or have trouble remembering to take oral treatments.
Denosumab is injected under the skin with no restrictions twice a year, while Fosamax and similar oral drugs require patients to be sitting up when they take the pills and not to eat for two hours before and 30 minutes after taking the drug, while Novartis AG's (NVS) once-yearly Reclast must be administered at an intravenous infusion clinic.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
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Publié le 19 Décembre 2008 Copyright © 2008 Dowjones