Amgen's great pipeline hope--Denosumab--has met all primary and secondary endpoints in a Phase III head-to-head trial against Fosomax. Denosumab, which is administered twice-yearly, is a fully-human monoclonal antibody for the treatment of bone loss. In the year-long study, the relative magnitude of bone mineral density improvement at the total hip was approximately 40 percent greater in the Denosumab versus the Fosomax group. A total of 1,189 women participated in the trial.
According to one analyst, Denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." It's the only potential blockbuster in Amgen's pipeline nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.
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ALSO: Amgen's sales fell 2 percent in the fourth quarter to $3.74 billion, but the company managed to eke out a $835 million profit for the period, an increase of 1 percent. Release