Sciele Pharma entered into an agreement with Galephar Pharmaceutical Research to develop and market a combination of fenofibrate and pravastatin to treat mixed dyslipidemia. Mixed dyslipidemia is the presence of elevated levels of LDL cholesterol and triglycerides and low levels of HDL cholesterol in the blood.
Sciele will be responsible for the Phase III studies and all regulatory filings with the FDA. It expects to use data from clinical trials that were conducted in Europe to supplement these U.S. filings. The company plans to begin enrolling patients in the Phase III evaluation during the first half of 2007.
Sciele will pay Galephar an upfront fee, a milestone payment after approval, and royalties on product sales. The company will have exclusive rights to bring this combination therapy to market in the U.S., Mexico, and Canada.