Just when things couldn't look any gloomier for Amgen. After a series of setbacks the Big Biotech is relying heavily on the future success of its late-stage denosumab osteoporosis therapy. One of the main attractions of the antibody therapy is its convenient route of administration: the drug will only have to be infused twice a year--a big improvement over weekly pill-taking that can lead to poor patient compliance.Too little too late?
In a three-year study of nearly four thousand patients, Novartis' once-a-year infusion Reclast (a.k.a. Aclasta, a.k.a. Zometa) was shown to decrease bone turnover and improve bone density at 12 months in postmenopausal women with osteoporosis. Results were published yesterday, in this week's New England Journal of Medicine.
Analysts have predicted the drug could be approved in that indication later this year. Although side effects included a higher rate of atrial fibrillation in the treatment group, the drug is on the market for other conditions, such as Paget's disease and the A-fib wasn't seen by observers as a deal breaker in osteoporosis either.
Amgen shares were down nearly two percent yesterday. Denosumab--currently being tested in a handful of late-stage trials, comprising a variety of oncology and bone-related indications--won't hit the market for postmenopausal osteoporosis until at least 2009. We'll take a look at Amgen's post-EPO R&D prospects in the May IN VIVO.
