4 Min Read
* Prolia approved for osteoporosis in women and men
* Amgen and Glaxo to share commercialization in Europe
* U.S. FDA to decide on drug by late July
* Glaxo rises 2 pct, Amgen up 0.7 pct (Adds details on analyst comments, U.S. applications, byline)
By Ben Hirschler and Ransdell Pierson
LONDON/NEW YORK, May 28 (Reuters) - Amgen's (AMGN.O) new drug Prolia, or denosumab, has been approved in Europe as a treatment for the brittle bone disease osteoporosis, the U.S. biotech giant said on Friday.
It was also approved for bone loss among men with prostate cancer who are treated with hormones used to knock down levels of testosterone that feeds the cancer. Such treatments make the men more prone to fractures.
The green light from the European Commission -- which had been expected following a positive recommendation by the European Medicines Agency in December -- marks the first approval of the product worldwide.
GlaxoSmithKline (GSK.L) will help commercialize the medicine in Europe, throwing its marketing weight behind a product that could reach $3.3 billion in global sales by 2014 if also approved in the U.S., according to Thomson Reuters.
Prolia is administered every six months as an under-the-skin injection and is the first in a new class of drugs designed to inhibit proteins that activate bone-destroying cells.
Initially, it will be given to women with post-menopausal osteoporosis and men with prostate cancer who, as a result of hormone therapy, are at increased risk of bone fractures.
The U.S. Food and Drug Administration is due to decide by late July whether to approve Prolia in osteoporosis.
"The EU approval of Prolia for these indications increases our confidence that the FDA will approve Prolia for post-menopausal osteoporosis on July 25," Lazard Capital Markets analyst Joel Sendek said in a research note.
Moreover, Amgen asked U.S. regulators earlier this month to approve denosumab for reduction of fractures and other skeletal-related problems in patients with advanced cancer, marking its second U.S. application for the experimental medicine.
Cowen and Co analyst Eric Schmidt said the European approvals "have some positive implications" for the looming U.S. decision. He said denosumab could capture "multibillion" dollar annual sales from the cancer indication alone, and annual sales of up to $1 billion for post-menopausal osteoporosis.
Amgen will provide Phase III data on denosumab in advanced cancer patients at a major cancer meeting next week.
The drug is widely considered to be Amgen's most important future growth driver, as safety concerns have continued to hurt sales of its Aranesp anemia treatment.
Amgen and Glaxo will collaborate to market the medicine in Europe for osteoporosis, while Amgen will retain full rights for North America and for oncology indications in Europe. Glaxo will handle sales in emerging markets.
Prolia will compete in the osteoporosis market against an established class of medicines called bisphosphonates.
These include Merck & Co's (MRK.N) Fosamax; Novartis's NOVN.VX Reclast; Warner Chilcott's WCRX.O Actonel; and Glaxo's own product Boniva or Bonviva, which it sells with Roche ROG.VX.
Glaxo's head of European pharmaceuticals, Eddie Gray, told Reuters at the time of the deal with Amgen last July that he aimed to start selling the medicine in the first European markets by mid-2010.
Glaxo shares rose 2 percent in London, while Amgen were up 38 cents at $51.81 the Nasdaq.
Reporting by Ben Hirschler; additional reporting by Ransdell Pierson and Bill Berkrot; editing by Simon Jessop and Derek Caney