FDA approval of competing Roche anemia drug could add to Amgen's woes, analysts say

WASHINGTON _ Besieged investors in biotech giant Amgen Inc. could be dealt another blow this week if federal regulators approve a rival anemia drug.

Amgen shares have dropped 15 percent to just over $54 since Thursday, when a panel of government advisers recommended that additional warning labels be added to the company's blockbuster anemia drugs. The Food and Drug Administration typically follows such recommendations and had already asked Amgen and Johnson & Johnson in March to add label warnings about the increased risk of blood clots, heart attack and death when their anemia drugs are used at higher-than-recommended doses.

Since nearly half of Amgen's annual revenue of $13.9 billion last year came from anemia drug sales, federal approval of Mircera, a rival drug made by Swiss drug company Roche, could make things tougher for Amgen investors. The stock is already 30 percent below its 52-week high of $77 hit in late October.

Wall Street analysts slashed stock ratings for Thousand Oaks, Calif.-based Amgen last week after the expert panel told the FDA that the company's anemia drugs need a comprehensive study to verify their safety. More analyst downgrades came after the government said it may stop paying for Medicare patients to receive the drugs if they have certain types of cancer.

The FDA is scheduled to decide later this week whether to give preliminary approval to Mircera, which like other anemia drugs uses a genetically engineered protein to boost red blood cell production. Anemia, a blood disorder that causes weakness and shortness of breath, often develops in patients who are receiving chemotherapy for cancer or who have chronic kidney disease.

Analysts are divided on the chances for Mircera's approval, given the safety issues raised last week. Citigroup analyst Paul Heldman put Mircera's chances for approval at 35 percent, down from his prediction of 65 percent before last week's meeting.

Thomas Weisel Partners analyst M. Ian Somaiya, however, says the FDA's decision on the Roche drug may not be impacted by last week's FDA meeting since the experts only looked at anemia drug use in cancer patients. Roche is seeking approval to use Mircera in patients with chronic kidney disease.

Roche says clinical trials show Mircera has a similar safety profile as existing anemia drugs. Still, preliminary approval for Mircera could further pressure Amgen shares, Somaiya said. Johnson & Johnson might also feel a pinch since it sold nearly $3.5 billion of Procit, its anemia drug, last year. But the impact would be lessened because the drug maker is far more diversified than Amgen.

If approved, Mircera would have one major advantage over competitors: it is given in longer-lasting monthly doses compared with weekly doses for Amgen's Aranesp and Epogen.

Dialysis center operators, such as DaVita Inc., which operates nearly 1,300 clinics in the U.S., could reduce costs if kidney disease patients only needed monthly rather weekly anemia drug infusions.

Shares of Amgen rose 32 cents Wednesday to $54.33.