Amgen's D-mab wins blockbuster approval in Europe

Amgen (NASDAQ: AMGN) can soon start watching the cash roll in for denosumab. After testing the bone-loss drug in a battery of late-stage trials, the therapy--to be sold as Prolia--won its first regulatory approval in Europe. GlaxoSmithKline (NYSE: GSK) will now collaborate with Amgen on the commercialization work on the continent for a drug that is expected to earn billions of dollars a year and help position the big biotech for the decade ahead.

Regulators approved the drug as a treatment for osteoporosis among post-menopausal women and prostate cancer victims who run a high risk for fractures. The drug inhibits proteins that trigger cells responsible for damaging bone, and Amgen is developing the therapy for a variety of bone-related ailments.

Amgen's D-mab is an odds-on favorite in the biotech industry for a U.S. approval, where the company will handle commercialization work alone. The FDA faces a July deadline for a final decision.

The discovery program began in an Amgen lab when researchers observed that one of the knockout mice it had developed during gene disabling research work had grown huge. "We noticed, hey that's a really big mouse," Amgen CEO Kevin Sharer recently told the Wall Street Journal. "It's really got big bones." 

- here's the Amgen press release
- here's the story from Reuters

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