Mylan Laboratories Inc announced that the SENIORS trial (Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalization in Seniors with heart failure), conducted in Europe by Menarini, demonstrated that, compared to placebo, nebivolol significantly reduced the combined primary endpoint of all cause mortality and cardiovascular hospital admissions in elderly patients with chronic heart failure.

The NDA is based on data from more than 2,000 patients enrolled in clinical trials to demonstrate the efficacy and safety of nebivolol in lowering blood pressure in hypertensive patients regardless of age, race or gender when administered once daily. In vitro studies have demonstrated that nebivolol is a highly beta-1 cardioselective blocker that also increases nitric oxide levels. In clinical trials nebivolol was well tolerated with an incidence of adverse events similar to that of placebo.

A total of 2,135 patients with an average age of 76 years were randomized in the trial. The results were announced on August 29, 2004, at the annual congress of the European Society of Cardiology (ESC) held in Munich, Germany.

Mylan vice chairman and CEO, Robert J Coury stated, "We would like to extend our congratulations to Menarini for having completed a successful heart failure study with nebivolol. These preliminary results, which were released yesterday at ESC, provide important additional data and further supports our excitement regarding the potential health benefits nebivolol may hold."

SENIORS was a multi-centre, multinational, double-blind, placebo- controlled, parallel group, randomized trial. The primary endpoint combined all cause mortality and cardiovascular hospital admissions. Patients recruited to the trial had to have a clinical history of chronic heart failure with either preserved or reduced left ventricular ejection fraction.

Mylan Laboratories Inc. has exclusive licensing rights to nebivolol in the United States and Canada and previously announced that on June 29, 2004, the Food and Drug Administration (FDA) accepted for filing its New Drug Application (NDA) for the use of nebivolol in the management of hypertension.

Menarini is an Italian based pharmaceutical company who licensed the rights to nebivolol in Europe, South America, the Middle East, Africa and Asia from Janssen Pharmaceutica.