Amgen's great pipeline hope [1]--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 [2] 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 [3] nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.
- see this release [4] for more
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 [5]
Related Articles:
Denosumab: Amgen's salvation? Report [1]
Amgen touts progress in two key programs. Report [6]
Amgen discusses the future with analysts. Report [7]
Links:
[1] http://www.fiercebiotech.com/story/denosumab-amgens-salvation/2007-12-14
[2] http://www.fiercebiotech.com/story/mabs-are-hottest-segment-biotech-industry/2007-10-12
[3] http://www.fiercebiotech.com/special-reports/9-amgen-top-15-r-d-budgets
[4] http://www.fiercebiotech.com/press-releases/denosumab-osteoporosis-study-met-primary-and-all-secondary-bone-mineral-density-endpo
[5] http://www.fiercebiotech.com/press-releases/amgens-fourth-quarter-2007-adjusted-earnings-share-eps-increased-11-percent-1-00-full
[6] http://www.fiercebiotech.com/story/amgen-touts-progress-in-two-key-programs/2007-04-24
[7] http://www.fiercebiotech.com/story/amgen-discusses-future-analysts/2007-09-11