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SkyePharma gets First Horizon milestone on Triglide OK

The FDA has approved SkyePharma's Triglide, a novel formulation of the cholesterol drug fenofibrate, triggering a $15 million milestone payment from First Horizon Pharmaceutical Corporation.

In May 2004, SkyePharma announced that it had granted First Horizon exclusive US marketing and distribution rights for a cardiovascular product (now identified as fenofibrate IDD-P). Under this agreement, SkyePharma will receive up to $50 million in milestone payments, $30 million of which are sales-based milestone payments. In addition SkyePharma will receive 25% of First Horizon’s net sales of the product.

SkyePharma will manufacture and supply the product from its Lyon, France manufacturing facility. SkyePharma will also make a contribution of up to $5 million to First Horizon’s initial marketing expenses to establish the product.

Fenofibrate is an oral treatment for lipid disorders such as elevated cholesterol and triglycerides. The main drawback of fenofibrate is insolubility in water, resulting in variable uptake from the stomach and requiring the patient to take the tablets with food. The Triglide formulation has a comparable absorption under fed and fasting conditions and therefore allows patients to take the drug at any time.