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Sciele Completes Enrollment of Patients in Pivotal Phase III Clinical Trial for the Combination of Pravastatin and Fenofibrate

Posted on: Tuesday, 9 October 2007, 09:00 CDT

Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that it has completed enrollment of patients in a pivotal phase III clinical trial using pravastatin and fenofibrate to treat mixed dyslipidemia. Mixed dyslipidemia is the presence of elevated levels of "bad" cholesterol, low-density lipoproteins (LDL) and triglycerides and low levels of "good" cholesterol, high-density lipoproteins (HDL) in the blood.

The phase III clinical trial is being conducted at approximately 75 sites in the United States. This study compares the combination of pravastatin and fenofibrate to pravastatin alone and fenofibrate alone.

Larry M. Dillaha, M.D., Executive Vice President and Chief Medical Officer of Sciele, said, "We are excited about completing the patient enrollment of this phase III trial using the combination of fenofibrate and pravastatin. Pravastatin is a well-recognized statin that has been used worldwide for the treatment of dyslipidemias. A growing number of patients suffer from mixed dyslipidemia and many of these patients are being treated with the combination of a statin and a fenofibrate. We believe this new combination product is an excellent strategic fit for our cardio-metabolic product portfolio."

Sciele Pharma, Inc. Background

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform -- an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

Safe Harbor Statement

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations.

Source: Business Wire

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