GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck &...( Following FDA Approval Agre...),Health

Following FDA Approval, Agreement will Broaden Access to

Cholesterol-Reducing Medicine

PHILADELPHIA and WHITEHOUSE STATION, N.J., Nov. 26 /PRNewswire/ -- 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(R) (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."

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 (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
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