Healthcare Industry News: GSK
News Release - November 26, 2007
GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.Following FDA Approval, Agreement will Broaden Access to Cholesterol-Reducing Medicine
PHILADELPHIA and WHITEHOUSE STATION, N.J., Nov. 26 (HSMN NewsFeed) -- 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 MEVACORŽ (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 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.
About prescription MEVACOR
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.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline at www.GSK.com.
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 GSK Consumer Healthcare
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 XenicalŽ 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.
GSK's education programs 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.
GSK forward-looking statement
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2006.
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 programs 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.
Merck forward-looking statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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