GlaxoSmithKline plc said it acquired the rights to sell over-the-counter (OTC) marketing rights of Merck's cholesterol lowering drug Mevacor (lovastatin) in the US.

Under the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck.

Mevacor was introduced in the United States in 1987 by Merck as the first in a class of cholesterol-reducing medicines known as "statins". The US patent for Mevacor expired in 2001.

The new drug application (NDA) for OTC MEVACOR will be reviewed by the US Food and Drug Administration in a joint meeting of the Non-prescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on 13 December 2007. The NDA, filed by Merck, is seeking approval of OTC Mevacor 20mg taken once daily to help lower cholesterol. OTC Mevacor 20mg is proposed for use in women age 55 and older and men age 45 and older with moderately elevated cholesterol and one or more heart disease risk factors.

Commenting on the agreement, JP Garnier, chief executive officer, GlaxoSmithKline said: "This new partnership with Merck will enable GSK to address the important public health issue of high cholesterol and help patients better manage their health. OTC Mevacor will be a dynamic new addition to our fast-growing over-the-counter business and is further evidence of GSK's ability to partner in new OTC switch opportunities."

Richard T. Clark, chief executive officer, Merck said: "With Mevacor, Merck pioneered the development of cholesterol-lowering medicines known as "statins" which are recognised worldwide and remain the standard of care today. We are pleased to be able to partner with GSK as a way to bring Mevacor directly to consumers in the US."

Application for OTC Mevacor to be reviewed by FDA

Mevacor is a prescription medicine that is approved in the US for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of first heart attack, unstable angina and coronary revascularisation procedures in healthy men and women with average or moderately elevated cholesterol levels.

According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. It is recommended that liver function tests be performed in all patients prior to daily use of Mevacor 40mg or more.

Muscle pain or weakness in patients taking prescription Mevacor could be signs of a serious side-effect. The most common adverse events reported with Mevacor 20mg taken once a day were diarrhoea, flatulence, headache and myalgia.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

OTC Mevacor would be marketed in the US by GSK Consumer Healthcare, a GSK division with a well-established record of bringing informed access to OTC medicines.

In 1996, GSK Consumer Healthcare launched the first OTC nicotine replacement therapies, Nicorette and NicoDerm CQ, together with an innovative Committed Quitters behavioural support programme. Through increased access to GSK's smoking cessation brands and support, more than five million adults in the United States have quit smoking, said the company.

In 2004, GSK Consumer Healthcare acquired the OTC marketing rights to orlistat in the US from the Roche Group (orlistat 120mg is marketed as the prescription product Xenical by Roche). In June 2007, GSK Consumer Healthcare launched alli in the US, the first FDA-approved OTC weight control medicine. alli (orlistat 60mg) provides overweight adults a proven weight loss medicine and a comprehensive, tailored, behavioural support programme.

GSK's education programmes provide consumers with information and the tools to support them through the behavioural modifications that are essential for their success with OTC medicines and that require long-term lifestyle changes.