Denosumab: Amgen's salvation?

2007 has been a rough year for Amgen. The world's largest biotech stumbled as it dealt with fallout from the anemia drug controversy. Safety concerns about the drug led to an FDA warning and caused sales of Amgen's most profitable drug to plummet. Analysts looked at the aging biotech and wondered if Amgen's glory days were over.

Now Amgen is looking to take a bite out of the $7 billion osteoporosis market with denosumab, a fully-human monoclonal antibody currently in Phase III testing. The drug is undergoing trials for bone loss induced by hormone ablation therapy for breast cancer or prostate cancer, prevention of cancer-related bone damage, postmenopausal osteoporosis, and prevention of bone metastases.

According to one analysts, denosumab "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." That would go a long way in turning around the company's fortunes. And denosumab is even more important to the company, as it's the only potential blockbuster nearing FDA approval. Amgen hopes to file an NDA for the drug in 2009.

- see this WSJ article for more

ALSO: Take a look at Amgen's pipeline. Report

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.