Sciele Pharma, Inc. has entered into an agreement with privately held 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 "bad" low-density lipoprotein (LDL) cholesterol and triglycerides, and low levels of "good" high-density lipoproteins (HDL) cholesterol in the blood.
Under terms of the agreement, Sciele will have exclusive rights to bring this combination therapy to market in the US, Mexico and Canada. Sciele Pharma will be responsible for the phase III clinical trials and all regulatory filings with the FDA and expects to use data from clinical trials that were conducted in Europe to supplement its regulatory filing in the US Sciele plans to begin enrolling patients in a pivotal Phase III efficacy and safety clinical trial in the US in the first half of 2007. Sciele will pay to Galephar an upfront fee, plus a milestone payment after FDA approval, and royalties on product sales.
"Based on the data from the European clinical trials, we are excited about the potential of this product," said Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma. "This combination of fenofibrate and pravastatin will be an excellent complement to, and expansion of, our cardiovascular/metabolic product portfolio. This combination will also provide us with another potential opportunity to leverage our primary care sales force."
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic and Women's Health. The Company's Cardiovascular/Metabolic products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes, and its Women's Health products are designed to improve the health and well-being of mothers and their babies.