Pharmacia Corporation announced that a major clinical study evaluating Inspra (eplerenone tablets) succeeded in meeting both of its primary endpoints according to results of the Eplerenone Post-AMI Heart Failure Efficacy and Survival Study (EPHESUS). The primary endpoints of the study were death from any cause and death or hospitalization from cardiovascular causes.

Based on the results of EPHESUS, the company plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration for Inspra in the treatment of post- myocardial infarction heart failure during the first half of 2003. The FDA approved INSPRA for the treatment of high blood pressure in September 2002.

"We are very pleased with the positive results of EPHESUS and the implications of this landmark study for advancing the treatment of patients with cardiovascular illness," said Fred Hassan, Chairman and Chief Executive Officer, Pharmacia Corporation. "At the same time, we are very proud of the work of our dedicated R&D team for this significant medical advance."

The EPHESUS trial was initiated in December 1999 and enrolled 6,644 patients at 674 centers in 37 countries. The randomized, double-blind, placebo-controlled trial evaluated the use of Inspra plus standard therapy on survival and morbidity in patients who had recently suffered a heart attack and also had early complications of heart failure as identified by left ventricular dysfunction. The company announced that no further details of EPHESUS will be available until all data analyses are complete and results are presented in a public, scientific forum.