Kos Pharmaceuticals Inc, through its European and international marketing partner, Merck KGaA, has received marketing authorization for Niaspan (niacin extended-release tablets) in France, the second largest pharmaceutical market in Europe. The cholesterol market in France was valued in excess of $1.1 billion in 2003.

German-based Merck KGaA plans to launch Niaspan in France in the second half of 2005, following the establishment of pricing and reimbursement for the product. As a result of the receipt of marketing authorization in France, Kos will receive a $2.5 million milestone payment from Merck KGaA, as well as royalties on net sales in the territory.

Niaspan, developed and manufactured by Kos, is indicated in France for the treatment of dyslipidemia, particularly in patients with combined mixed hyperlipidemia characterized by elevated levels of LDL-cholesterol (LDL-C) and triglycerides, low HDL-cholesterol (HDL-C), and in patients with primary hypercholesterolemia.

Niaspan is to be used in combination with statins when response to statins is inadequate or as monotherapy when patients are intolerant to statins. Niaspan is a safe and highly effective therapy for the treatment of low HDL-C, increasing the mean HDL-C levels up to 30 per cent. Kos launched Niaspan in the United States in 1997 and recorded net sales of $227 million in 2003.

"The French approval brings Niaspan, which treats a broad range of lipid disorders, most especially by raising HDL-C, to yet another major market in Europe and represents an additional significant milestone in continuing successes for Kos," asserts Adrian Adams, president and CEO of Kos. He added, "Additionally, with nearly twice as many patients in Europe than in the US projected to suffer from dyslipidemia in 2004, we are confident that this critical cholesterol therapy will make a significant difference in improving the health of patients in Europe."

In the fall of 2002, Kos and Merck KGaA had entered into an agreement for Merck KGaA to market and distribute both Niaspan and Advicor (niacin extended-release/lovastatin tablets) throughout the world, excluding North America and Japan.

Niaspan has now been approved in 12 of those European countries since the completion of the MRP process, which include such markets as Germany, Austria, Ireland, Belgium and the Netherlands. Merck KGaA and Kos are now initiating a second wave of the Mutual Recognition Procedure (MRP) for the additional 10 European countries that were recently added to the list of European Union countries.