Eisai’s Severe Sepsis Drug Fails in Final-Stage Study

Eisai Co. said its experimental drug to treat severe sepsis failed to save more lives than a placebo in a final-stage study.

The company won’t seek regulatory approval for eritoran in the U.S., Europe and Japan by March 31 as previously planned, Tokyo-based Eisai said in a statement today. Eisai said it will continue analyzing the trial data and determine its next course of action.

Eritoran was on course to be the first new treatment in a decade for the disease caused by bacterial infection that causes the immune system to attack the body, killing one in three patients in the U.S. The trial result is a setback for Eisai, which needs new medicines to cope with generic-drug competition after its Aricept, the world’s best-selling Alzheimer’s disease treatment, lost patent protection in the U.S. in November.

“This is harsh,” Atsushi Seki, an equities analyst at Barclays Plc in Tokyo, said by telephone today. “I can’t see Eisai’s next step to bring growth. It has debt, it’s hard to see growth in its pipeline and its cash will be tight.”

Many previous trials of potential drugs have failed to improve patients’ outcome, said Mark Tidswell, interim chief of the critical care unit at Baystate Medical Center in Springfield, Massachusetts.

Few Options

“Severe sepsis remains an unmet need with few options,” Tidswell, who was part of an earlier eritoran trial, said in an e-mail before Eisai’s announcement.

Eisai’s American depositary receipts, each worth one ordinary share, fell $2.47, or 7 percent, to $33 as of 4:22 p.m. New York time. They have lost 11 percent in the last 12 months.

The eritoran trial began in June 2006 and was in the last stage of patient studies generally required to seek regulatory approval. It studied about 2,000 patients aged 18 years and older and compared their mortality rate after 28 days of hospitalization.

Sepsis patients suffer a drop in blood pressure that leads to shock, and their major organs including the kidneys, liver and lungs stop working properly, according to MedlinePlus, a website of the U.S. National Institutes of Health. About 750,000 people in the U.S. develop sepsis every year and 30 percent to 35 percent of patients die, Eisai said.

Organ Failure

Patients with organ failure are given antibiotics and may undergo surgery to drain the infection, Tidswell said.

The drug, the first in a new class of sepsis treatments, would have competed with Indianapolis-based Eli Lilly & Co.’s Xigris, which had sales of $127.3 million in 2009, according to data compiled by Bloomberg. Talactoferrin alfa, a potential competitor from Heidelberg, Germany-based Agennix AG, is in the last stage of development.

If approved, eritoran may achieve annual peak sales of $2 billion in 2021, according to Atsushi Seki at Barclays Plc.

“I have high expectations for the drug,” Seki, an equities analyst at Barclays in Tokyo, said on Dec. 28.

Aricept generated 322.8 billion yen ($3.9 billion) in the year ended March 2010, equivalent to 40 percent of the company’s revenue.

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