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PHARMACEUTICALS

Amgen's anemia drugs take fresh hit

Studies raise concerns about the medications' safety, which could lead to further limits on use.

January 04, 2008|Daniel Costello | Times Staff Writer

Anemia drugs sold by Amgen Inc. took another hit Thursday when government regulators said two new studies indicated that the drugs may increase the risk of death in some patients.

Based on the studies, the Food and Drug Administration may further restrict the use of the drugs, which already carry the agency's strictest "black box" warning.

"This new information further underscores the safety concerns," said Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research. She said the agency "is reviewing these data and may take additional action."

In recent years, six studies have found that the drugs -- all manufactured by Amgen and marketed by Amgen as Aranesp and Epogen and by Johnson & Johnson as Procrit -- can lead to an increased risk of heart attack, stroke, heart failure and cancer tumor growth in some patients.

Amgen, based in Thousand Oaks, until recently enjoyed an unusually charmed life in the often treacherous biotech industry, with profit and a market value higher than many top-shelf pharmaceutical companies. A large share of the company's fortunes came from Aranesp and Epogen, which accounted for more than half of its net income.

Since the summer, Amgen's stock has fallen to a five-year low and has lost $17 billion in value. The company laid off 14% of its employees late last year.

Known as erythropoietin-stimulating agents or ESAs, the anemia drugs are bioengineered versions of a natural protein made in the kidney that stimulates bone marrow to produce more red blood cells. Cancer and dialysis patients use injectable ESAs to treat anemia and boost energy.

Fallout from the earlier studies' findings rankled patients and regulators. The FDA added the black box warning last year and the federal Medicare agency followed with limits on what dosages of anemia drugs it would reimburse, severely affecting the company's sales.

The results of the two most recent research studies appear to reinforce concern that some cancer patients die sooner when taking the drugs than those who don't.

The first involved 733 women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14% of the patients who received Aranesp to treat their anemia had died, compared with 9.8% who didn't receive the drug. Tumors also grew faster in patients receiving Aranesp.

Amgen informed FDA officials about the findings in late November and regulators have been reviewing the data since.

A separate trial by the National Cancer Institute's Gynecologic Oncology Group, the results of which Amgen disclosed to federal regulators in December, reviewed patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were administered either Procrit or blood transfusions as needed. After three years, 66% of patients who did not take Procrit were alive and free of cancer growth, compared with 58% given the drug.

The FDA previously said it would hold a meeting early this year to look at the safety of the drugs in cancer patients, but a date has not yet been set.

Roger M. Perlmutter, executive vice president of research and development at Amgen, said in a statement in December that "as new information, including additional study results, becomes available, Amgen will communicate the data and, where appropriate, work with the FDA to update our product labels."

Wall Street appeared to take Thursday's news in stride, perhaps because many of the risks facing the company had already been priced into the stock. Shares of Amgen fell 91 cents, or 2%, to $45.69.

Joel Sendek, senior biotechnology analyst at Lazard Capital Markets, said in a note to clients that "we continue to forecast revenue decline in 2008 and limited [stock price] growth to 2010."

Sendek upgraded the stock to a "hold" recommendation from a rare "sell," saying he believes that the company's shares are fairly valued at this level.

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daniel.costello@latimes.com

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