Kos Pharmaceuticals, Inc. announced that Merck Pharmaceuticals, UK, a subsidiary of Merck KGaA, Germany, has launched Niaspan (extended-release niacin) in the UK, a cholesterol market valued at approximately £800 million during the last twelve months.
Niaspan, developed and manufactured by Kos is indicated in the UK label for use as an adjunct to diet to decrease total and LDL-C ("bad" cholesterol), ApoB and triglyceride (TG) levels, and to increase HDL-C ("good" cholesterol). Through Kos' commercialization partner, Merck KGaA, the UK launch marks the first introduction of this potent and broad dyslipidemic agent to patients outside the United States and marks another key milestone that contributes to the overall positive outlook for Kos.
Cardiovascular disease accounted for over 245,000 deaths in 2001, and remains the leading cause of death in the UK, according to the British Heart Foundation. Niaspan is a safe and effective therapy option, primarily for the treatment of HDL-C, a major independent risk factor for cardiovascular disease. Commenting on the launch of Niaspan, Dr. Anthony Wierzbicki, department of chemical pathology at St. Thomas' Hospital in London said, "The importance of raising HDL-C in lipid management has long been underestimated. Clinical trials and new guidelines highlight the significance of raising HDL-C as well as reducing LDL-C. Niaspan corrects HDL-C, triglycerides and LDL-C subfraction distribution. Together, Niaspan and statins comprises an important well-tolerated, and evidence-based combination therapy."
Merck KGaA, who entered into an agreement in 2002 with Kos for worldwide marketing rights to both Niaspan and Advicor, (niacin extended-release/lovastatin), excluding North America and Japan, will be the distributor in the UK and other European markets once approved. In Europe, it is estimated that more than 84 million patients will be living with dyslipidemia by 2004 and only 12 million are projected to receive therapy.
Furthermore, the European market for cholesterol products exceeded $3.5 billion in 2001 and is expected to grow to approximately $10 billion by 2007. Subject to the European Union's mutual recognition procedure (MRP), approvals for Niaspan are expected in 14 other major international markets, most notably Germany, France, Spain, and Italy. These multinational approvals are expected in early 2004 onwards. Merck KGaA anticipates the launch of Niaspan in these major international markets during 2004 and 2005, subject to the establishment of pricing and reimbursement, which occurs on a country-by-country basis. Advicor, which is currently pending approval in the UK, the reference member state, is likely to be launched in major European markets by 2005.
"This launch represents another major milestone for Kos in that it brings Niaspan, the most effective and user-friendly form of extended-release niacin, to millions of patients suffering from cholesterol disorders in the
UK, where a shocking one in four deaths in men and one in six deaths in women resulted from coronary heart disease in 2001," stated Adrian Adams, president and CEO of Kos. "Additionally, with nearly twice as many patients in Europe than in the U.S. 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 the patients worldwide."
The managing director from Merck Pharmaceuticals, Dr. Soeren Hermansson, added, "Merck KGaA is committed to the treatment of dyslipidemia. The launch of Niaspan provides Merck with the exciting opportunity of being the first company to provide a once-daily modified release formulation of nicotinic acid, an effective means of increasing HDL-C and a critical component in the successful treatment of coronary heart disease in the UK."