Amgen wins FDA approval of D-mab

Two months ahead of schedule and just days behind European regulators, the FDA has approved Amgen's denosumab for postmenopausal women with osteoporosis. Once the drug hits the market as Prolia, analysts expect that it will evolve into a multibillion-dollar franchise product--marking a key turning point for the world's biggest independent biotech.

Patients will be able to get the two annual injections at a cost of about $1,650. At that price Amgen believes it can snare a significant chunk of the market for osteoporosis drugs, which already counts a number of competing therapies. The price also helped win over analysts who were happy to see Amgen get aggressive.

"We view this positively as it appears that Amgen was pricing Prolia with the oncology indications in mind," wrote Citi analyst Yaron Werber, according to a piece in TheStreet. "Using this price, the annual cost for the cancer indications (once monthly at double the dose) translates to $19,800 versus our projection of $12,240."

The biotech giant has mounted six late-stage trials designed to bring home data supporting the drug's use in cancer patients, both to prevent bone complications as well as a weapon to guard against the spread of prostate cancer to the bones. D-mab hit a speed bump last fall when the developer was forced to supply additional information to the FDA to support its application. But the company didn't have to wait until the FDA's deadline next month to get a green light to start marketing the therapy.

"We're not trying to go out there and take business away from existing drugs... but we recognize that this is a very unsatisfied group of patients that need other options," Roger Perlmutter, Amgen's EVP of research and development, told the Wall Street Journal.

- here's Amgen's release on the approval
- read the story from the Wall Street Journal
here's TheStreet report
check out the story from Bloomberg