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Trial of Amgen drug was halted

The study of an anemia treatment found higher tumor risks, the firm says four months later.

February 17, 2007|Daniel Costello | Times Staff Writer

Amgen shares fell 2% Friday after the company disclosed that an independent study of its lucrative anemia drug Aranesp was halted in October because researchers linked it to a higher recurrence of tumors in some cancer patients.

Chief Executive Kevin Sharer said the company informed U.S. and European regulators as soon as it learned of the study's findings. But he acknowledged that the public and investors should have been told at the same time.

"In retrospect, it would have been ideal to mention that the study was stopped," Sharer said in a conference call with reporters and stock analysts. "We will do that going forward."

The shutdown of the Denmark-based trial raises fresh questions about the anemia drug and similar products, experts said, and the delay in publicly disclosing the setback could undermine Amgen's credibility with medical professionals and Wall Street.

"We rely on [manufacturers] for some information and when it is not disclosed in a timely manner, it's cause for concern," said Scott Evans, director of pharmacy at the USC Norris Cancer Center, where the anemia drug is commonly used. "I think it definitely could be a credibility issue."

The delayed public announcement could also make the biotechnology giant more vulnerable to lawsuits from disgruntled investors, said attorney Daniel Lefler, who specializes in securities law at Los Angles-based Irell & Manella.

"It sounds to me there may be a problem here," Lefler said.

Amgen shares fell $1.55 on Friday to $66.73.

Aranesp is part of a class of medicines called erythropoietin that treat anemia by boosting the body's production of red blood cells. The drugs are used by more than 1 million patients in the U.S. and accounted for nearly $10 billion in sales in 2006.

Aranesp generated $4.12 billion for Amgen last year, or 29% of the Thousand Oaks-based company's revenue.

Aranesp has FDA approval to treat anemia caused by chemotherapy. The Danish study was investigating its use with cancer patients who weren't undergoing chemotherapy, such as those being treated with radiation.

The Danish Head and Neck Cancer Group said that its independent study showed that patients given Aranesp experienced the recurrence of tumors at a higher rate than those not given the drug.

As a result of those findings, the researchers discontinued the study Oct. 18. Amgen said it had not yet seen complete data from the trial but planned to review the findings.

The new research is significant because it is the latest indication of potential problems associated with this class of anemia drugs, at least for some patients.

When it reported its fourth-quarter earnings Jan. 26, Amgen disclosed that one of its own trials showed that some cancer patients given Aranesp had a higher risk of dying.

Before that, a study published in the New England Journal of Medicine in November found that patients with kidney disease who were treated aggressively with Procrit -- another version of erythropoietin made by Johnson & Johnson -- had a 34% higher risk of heart problems or death than those treated less aggressively.

An expert panel of doctors for the National Kidney Foundation is assessing whether to change guidelines for how patients should be treated.


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