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Saturday, November 21, 
10:59 pm

With bone drug data, Amgen not so brittle

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LaboratorySmall.pngA year ago we asked whether Amgen Inc., biotech's biggest revenue maker, could be ripe for the plucking.

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The firm had bad news about its flagship anemia treatments Epogen and Aranesp -- so-called EPO drugs -- used to combat the side effects of chemotherapy and kidney dialysis. Serious safety concerns led to Food and Drug Administration warnings and a curtailment of the U.S. Medicare program's reimbursement guidelines. From $75 in October 2006, the stock lost a third of its value by August 2007. It hit bottom this March around $40. Foes were calling for the head of CEO Kevin Sharer.

But good data from its osteoporosis drug denosumab, or d-mab for short, means Amgen, though not out of the woods, is at least a more expensive takeover proposition. The firm reported Friday that in a three-year Phase 3 trial of 7,800 postmenopausal women, d-mab, injected twice a year, seems to reduce fractures in the spine and hip significantly compared to placebo. Investors have bumped the stock 11% to $60 in late trading Monday, the highest mark since May 2007.

Amgen's market cap is now around $65 billion, with an enterprise value a liuttle less than $61 billion. Merck & Co. currently dominates the osteo market with Fosamax, which just went off-patent, but it's unlikely that Merck wil take out Amgen just for d-mab, whose sales are projected by Deutsche Bank AG at just over $3 billion annually in 2016. Merck would likely try to license out d-mab in some way. The big problem at Amgen is the EPO franchise, which is sinking fast. Combined sales of Aranesp and Epogen fell in the first quarter to $1.32 billion, down 20% from the year-ago quarter. Combined sales of Aranesp and Epogen fell in the first half to $2.75 billion, down 14.5% from the first half of 2007, but it's worth noting sales figures for both drugs beat analyst estimates.

Before we pronounce Amgen full recovered, remember that d-mab still has to pass FDA muster and convince doctors and insurers it's worth prescribing over other osteoporosis meds, including new generic versions of Fosamax. Also note that Amgen might sell commercial rights to d-mab instead of building its own expensive sales force. That could cut deeply into its share of revenues.

Amgen's last great blockbuster hope, colon cancer treatment Vectibix, has nearly fallen off the map after 18 months on the market. It pulled in $34 million in the first quarter of 2008. Amgen paid $2.2 billion to buy out its development partner Abgenix Inc. in late 2005. - Alex Lash





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