J&J Unit Orders Heart Failure Drug Test

NEW BRUNSWICK, N.J. – Johnson & Johnson’s Scios Inc. unit has commissioned the Duke Clinical Research Institute to perform a study of the safety and effectiveness of its heart failure drug Natrecor.

The study will involve some 7,000 patients and is expected to begin enrolling patients in the first half of 2007, Johnson & Johnson said Thursday.

Sales of Natrecor dropped significantly over the past year after outside scientists questioned whether it raised the risk of kidney problems and death.

Natrecor was once seen as a likely blockbuster drug and its development was the primary reason J&J paid $2.4 billion to acquire Scios, a Fremont, Calif.-based biotech business, in 2003.

The drug treats acute decompensated heart failure, a life-threatening condition in which the heart suddenly stops pumping effectively, leaving patients weak and gasping for breath. Natrecor was approved in 2001 after studies showed it could quickly improve shortness of breath among patients with the condition.

DCRI, the clinical research organization within Duke University Medical Center, will collaborate with the Cleveland Clinic Cardiovascular Coordinating Center in managing the trial and other leading medical centers around the world will participate, J&J said.

Dr. Robert M. Califf, director of DCRI, will serve as chairman of the trial.

Califf said the trial "will provide important clinical data about the impact of Natrecor on outcomes that matter: most importantly, symptom relief, readmission to the hospital for heart failure and death."

He added that the study would be conducted "with the type of independence that is required to provide confidence to the clinical community and the public in the results of the trial."

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