Amgen shares fall as FDA officials urge dosing studies for anemia drugs in kidney patients

Amgen shares dip on anemia drug concerns

NEW YORK — Shares of Amgen Inc. fell Thursday over concerns that the Food and Drug Administration’s plan to re-examine the safety of anemia drugs could pressure sales of leading anemia treatments Aranesp and Epogen.

FDA officials plan to form a panel of outside experts to re-examine the safety of certain epoetin alfa anemia drugs, including Aranesp, Epogen and Johnson & Johnson’s Procrit. Agency officials, in a New England Journal of Medicine article, said studies should be conducted to establish the proper dosing for chronic kidney disease patients taking the anemia drugs.

The drugs stimulate the formation of oxygen-carrying red blood cells in the bone marrow. They are given to patients with anemia due to cancer treatment and kidney disease to reduce or eliminate the need for blood transfusions.

The article comes months after a study raised concerns that certain anemia drugs doubled the risk of stroke in people with diabetes and chronic kidney problems.

Amgen, in particular, has been hurt by the increased safety scrutiny. The FDA has repeatedly strengthened the warning labels on anemia drugs over the last two years, following concerns they might worsen the survival rate of certain cancer patients. Analysts have mainly factored in the sales impact, with many previously saying the years-long sales decline in Aranesp may have reached a plateau.

The issue now focuses on whether chronic kidney disease patients should be given lower doses of the drugs because of potential heart risks. In 2007, the Centers for Medicare and Medicaid Services changed the reimbursement policy for Aranesp and other drugs in the same class, with doctors only being paid for using a low dose of the drugs.

For Amgen, based in Thousand Oaks, Calif., the planned FDA advisory panel on anemia drugs, along with reviews for its experimental osteoporosis drug Prolia, could create “a choppy year,” said Leerink Swann analyst Dr. Joshua Schimmer.

“We would like to believe that current (share) price reflects any potential damage to the chronic kidney disease franchise that could result from TREAT (the reason study), but shares may still be volatile around these updates which serve as a reminder to investors that Amgen’s base business faces important challenges in the coming years,” he wrote in a note to investors.

Aranesp is a best-selling drug for Amgen, but safety concerns and stricter warnings have continued to pull down sales. In the most recent third quarter, sales fell 19 percent to $685 million. Together, Aranesp and Epogen brought in $1.35 billion in quarterly revenue, out of total product sales of $3.74 billion.

Meanwhile, Wall Street has been looking to Prolia as the key to reviving revenue. In October, the FDA requested more information, specifically a risk-mitigation plan, on the osteoporosis drug before considering it for approval.

Amgen shares fell 45 cents to $56.34 in afternoon trading, rebounding from an intraday low of $54.65. Shares have traded between $44.96 and $64.76 over the last 52 weeks. Shares of Johnson & Johnson fell 67 cents to $63.78.