GlaxoSmithKline, Philadelphia, PA, USA (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 GSK's ability to partner in new OTC switch opportunities."
"With MEVACOR, Merck pioneered the development of cholesterol-lowering medicines known as "statins" which are recognized worldwide and remain the standard of care today," said Richard T. Clark, chief executive officer, Merck. "We are pleased to be able to partner with GSK as a way to bring MEVACOR directly to consumers in the United States."
The new drug application (NDA) for OTC MEVACOR will be reviewed by the U.S. Food and Drug Administration (FDA) in a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on December 13. The NDA, filed by Merck, is seeking approval of OTC MEVACOR 20 mg taken once daily to help lower cholesterol. OTC MEVACOR 20 mg 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.
MEVACOR is a prescription medicine that is approved in the United States 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 revascularization 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 40 mg 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 20 mg taken once a day were diarrhea, flatulence, headache and myalgia.
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.
OTC MEVACOR would be marketed in the United States 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 program. 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 United States from the Roche Group (orlistat 120 mg is marketed as the prescription product Xenical(R) by Roche). In June 2007, GSK Consumer Healthcare launched alli in the United States, 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 program.