Merck expected to launch Niaspan by the end of 2003
Merck KgaA, of Germany, has received final regulatory approval from the Medicines And Healthcare Products Regulatory Agency in the UK for that Niaspan (extended-release niacin), its dyslipidemia treatment.
Merck KgaA, of Germany, has received final regulatory approval from the Medicines And Healthcare Products Regulatory Agency in the UK for that Niaspan (extended-release niacin), its dyslipidemia treatment.
Merck, which entered into a 2002 agreement with Kos Pharmaceuticals for worldwide marketing rights to both Niaspan, excluding North America and Japan, will be the distributor in the UK and plans to launch the product by the end of 2003.
Under the EU's Mutual Recognition Procedure (MRP), Kos also plans to submit marketing authorisa-tion applications for Niaspan in other major EU countries during the second half of this year, with the UK acting as the reference country. Subject to approvals under the MRP, Merck KGaA expects to launch in major markets during 2004 and 2005, following the establishment of pricing and reimbursement for Niaspan, which occurs on a country-by-country basis.
Niaspan, the only once-daily formulation of ex-tended-release niacin approved by the US FDA for treatment of multiple lipid disorders, had sales of $146m (€124m) in 2002. The European market for cholesterol products exceeded $3.5bn (€3.0bn) in 2001.