UPDATE 2-Amgen trial finds no heart benefit with Aranesp

Tue Aug 25, 2009 6:49pm EDT

* No effect on risk of death, cardiovascular events

* No improvement in progression to end-stage renal disease

* Aranesp linked to greater risk of stroke

* Shares down by fraction of percentage point (Adds analyst comment, background, share price, byline)

By Deena Beasley

LOS ANGELES, Aug 25 (Reuters) - A trial of Amgen Inc's (AMGN.O) Aranesp found the blockbuster anemia drug does not have a significant effect on the risk of heart attack and other cardiac events in kidney patients, the company said on Tuesday.

The study, known by the acronym TREAT, also failed to show that Aranesp delayed the onset of end-stage renal failure.

Sales of bioengineered anemia drugs, including Aranesp, Amgen's Epogen and Johnson & Johnson's (JNJ.N) Procrit have fallen sharply since a late 2006 study by J&J showed a higher risk of death and cardiovascular complications for aggressively treated patients.

Wall Street had "no expectations" for the Amgen study, said Morgan Joseph & Co analyst Shiv Kapoor. "We have to see the detailed data -- if anything it might add to safety."

The company's shares, which closed at $60.36 on Nasdaq, were fractionally lower at $60 after hours.

The trial is not expected to change utilization in chronic kidney disease since it was not designed to determine an appropriate hemoglobin target, BMO Capital Markets analyst Jason Zhang said in a research note.

Initial results from Amgen's large, Phase III trial of patients with chronic kidney disease, anemia and type-2 diabetes found treatment with Aranesp did not have a significant effect on the risk of death, serious heart complications, or the time it took for a patient to progress to dialysis therapy, compared with a placebo.

The five-year trial did show that patients treated with Aranesp, up to a hemoglobin target of 13 grams per deciliter, were more likely to suffer a stroke -- a risk noted in the drug's label.

"In contrast to a recent, smaller study ... in a similar patient population, TREAT did not show a statistically significant adverse effect on all-cause mortality or cardiovascular morbidity when patients were treated to a hemoglobin target of 13 g/dL," Roger Perlmutter, head of research and development at Amgen, said in a statement.

Current guidelines call for patients to be treated to achieve and maintain hemoglobin levels of 10 to 12 g/dL.

"TREAT studied uses for Aranesp in which it is not approved," Amgen said in a statement.

From 2006 to 2008, worldwide annual Aranesp sales fell 24 percent to $3.1 billion. Procrit sales slid 23 percent to $2.46 billion over the same period.

Amgen, based in Thousand Oaks, Calif, said its summary results will be followed by full efficacy and safety analyses, which will be shared with global regulatory authorities and presented at a medical meeting later this year. (Reporting by Deena Beasley; editing Bernard Orr, Carol Bishopric editing by Andre Grenon)

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