GlaxoSmithKline plc (GSK) and Merck & Co., Inc., Whitehouse Station, NJ, USA (Merck), announced today that they have entered into an agreement for over-the-counter (OTC) marketing rights for Mevacor® (lovastatin). 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 U.S. patent for Mevacor expired in 2001.
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 GSKâs 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 U.S."
Application for OTC Mevacor to be reviewed by FDA
The new drug application (NDA) for OTC Mevacor will be reviewed by the U.S. 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.
About prescription Mevacor® (lovastatin)
Mevacor is a prescription medicine that is approved in the U.S. 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 should be reported to a doctor because these could be signs of a serious side-effect. Patients should tell their doctors about other medications they are taking in order to avoid possible drug interactions.
The most common adverse events reported with Mevacor 20mg taken once a day were diarrhoea, flatulence, headache and myalgia.
Mevacor® (lovastatin) is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA
About GlaxoSmithKline
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. For more information, visit http://www.gsk.com.
About GSK Consumer Healthcare
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 behavioral 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.
In 2004, GSK Consumer Healthcare acquired the OTC marketing rights to orlistat in the USfrom 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, behavioral support programme.
GSK's education programmes provide consumers with information and the tools to support them through the behavioral modifications that are essential for their success with OTC medicines and that require long-term lifestyle changes.
Nicorette, NicoDerm CQ and alli trademarks are either owned by and/or licensed to GSK or associated companies. Xenical is a registered trademark of the Roche Group.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programmes that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.