GlaxoSmithKline (GSK) and Merck of Whitehouse Station, N.J., have entered into an agreement for over-the-counter (OTC) marketing rights for Mevacor (lovastatin).
Mevacor is currently a prescription-based statin for the treatment of elevated cholesterol levels 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 London-based GSK. The U.S. patent for Mevacor expired in 2001.
The FDA will review the new drug application (NDA) for OTC Mevacor in a joint meeting of the Non-prescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 13.
Under the terms of the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. The specific terms of the agreement are confidential but GSK said that will include milestone and royalty payments to Merck.
“We are pleased to be able to partner with GSK as a way to bring Mevacor directly to consumers in the U.S," according to Richard T. Clark, CEO of Merck.