Amgen study shows no increased Aranesp death risk

By Bill Berkrot

NEW YORK (Reuters) - Amgen Inc.'s. (AMGN.O) anemia drug Aranesp showed no increased risk of death compared to a placebo in a study of small-cell lung cancer patients undergoing chemotherapy, sending its shares up more than 7 percent.

The company released data from the closely watched study on Thursday. Aranesp and similar anemia drugs have been under fire amid concerns that they have been used too aggressively and could be harming patients.

Industry analysts had called results of this study critical to future use of Amgen's most important product. Aranesp had sales of about $4.1 billion last year, and along with its predecessor Epogen accounted for roughly half of Amgen's sales.

"This was the A No. 1 issue and now that's behind us," said Christopher Raymond, a biotech analyst for Robert W. Baird.

"I think this means patterns stabilize in terms of physician use of the drug," he said.

Had study 145 shown that Aranesp increased the risk of death in cancer patients undergoing chemotherapy, it would likely have wiped out the lion's share of Aranesp sales. Chemotherapy-induced anemia is by far the most important use for Aranesp.

"I don't know that we're going to see a massive commercial impact from this, but this trial probably removes the worst fears that investors had that Aranesp was going to go away," said Cowen and Co. analyst Eric Schmidt.

Amgen's research and development chief Roger Perlmutter said in a statement that the data "contribute to the growing body of evidence on (Aranesp) safety, reinforcing the neutral impact on survival in cancer patients suffering from chemotherapy-induced anemia."

Aranesp, Epogen and Johnson & Johnson's Procrit are all forms of the natural protein erythropoietin used to treat anemia by stimulating the body's production of hemoglobin, the protein in red blood cells that carries oxygen.

"This was a study that had some real risk for Amgen, so there's obviously a relief rally in the stock," said Sanford Bernstein analyst Geoffrey Porges.

The neutral outcome on survival pushed Amgen's beaten down shares as high as $64.40 on Nasdaq. They were up $3.64, or 6 percent, to $63.65 in late morning trade.

Following a wave of concerning news on the anemia drugs, including increased death seen in an Aranesp study of cancer patients who were not on chemotherapy, the U.S. Food and Drug Administration last month slapped a strong new warning on the medicines, calling on doctors to use the lowest dose that can effectively avoid the need for blood transfusions.

Amgen, the world's largest biotechnology company, said patients who received Aranesp in study 145 had a significantly lower risk of blood transfusions as the drug significantly boosted hemoglobin levels.

But Bernstein's Porges cautioned that this study does not remove the cloud hanging over Aranesp, saying that it proves little about the overall safety of the class of drugs.

"We simply cannot extrapolate from a relatively unique rapidly progressive disease like small-cell lung cancer into other tumor types," Porges said. "I think the FDA is going to take a hard look at all those other tumor types at the panel meeting in May."