Merck Announces Preliminary Analyses of Off-Drug Extension of APPROVe Study

WHITEHOUSE STATION, N.J., May 11, 2006 - In the off-drug follow-up period for patients in the APPROVe study, there was not a statistically significant difference in the risk of confirmed thrombotic cardiovascular events in patients who had previously taken VIOXX compared to those who had previously taken placebo, according to preliminary analyses announced today by the study sponsor, Merck & Co., Inc.  This prespecified analysis included patients regardless of when they discontinued study therapy.  Furthermore, in the one-year off-drug follow-up period for patients who completed approximately three years of therapy in the APPROVe study, there was not a statistically significant difference in the risk of confirmed thrombotic cardiovascular events in patients who had previously taken VIOXX compared to those who had previously taken placebo.  In these analyses, the data were insufficient to conclude that there was an increased relative risk of confirmed thrombotic cardiovascular events following discontinuation of therapy.  In the prespecified primary analysis of each patient's four-year data (that combined data from the on-drug period and the off-drug period regardless of when patients discontinued study therapy) the difference in the risk of confirmed thrombotic cardiovascular events between groups initially observed in the on-drug period of the study remained statistically significant. 

In the four-year data, there was an increased relative risk of confirmed heart attacks in the VIOXX group compared to the placebo group and an increased relative risk of confirmed ischemic strokes in the VIOXX group compared to the placebo group.  Mortality was similar between the VIOXX and placebo groups in the four-year data.  These preliminary analyses have been shared with regulatory agencies.

"Our preliminary analyses of the off-drug period did not demonstrate a statistically significant increased risk of confirmed cardiovascular thrombotic events after patients in the APPROVe study stopped taking VIOXX," said Peter S. Kim, Ph.D., president of Merck Research Laboratories.  "The limited data in the APPROVe study on stroke have to be interpreted in the context of the extensive data we have previously published, which consistently showed no increased risk of strokes in patients taking VIOXX."

The Company reported the results of the three-year APPROVe study (the "base study") in September 2004.  As previously reported, in the base study, there was an increased relative risk for confirmed thrombotic cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo.  Given the questions raised by the data in the base study and the perceptions regarding alternative therapies available, the Company decided to voluntarily withdraw VIOXX worldwide at that time.  In accordance with the APPROVe clinical study protocol, the Company announced that it planned to follow patients for one year after they came off treatment.  The results announced today are the preliminary safety analyses including this follow-up period.

A copy of the summary report of confirmed thrombotic cardiovascular events from the APPROVe off-drug extension, which was shared with regulatory agencies, is attached and available by visiting: The VIOXX Information Center on www.merck.com.

About the APPROVe Study
APPROVe (Adenomatous Polyp Prevention on VIOXX) was a multi-center, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy of 156 weeks (three years) of treatment with VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas.  The one-year off-drug extension of APPROVe addressed recurrence of polyps, thrombotic cardiovascular events and mortality.  Recurrence of polyps will be addressed in a future publication.

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 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 www.merck.com.

Forward-Looking Statement
This press release (including the attachment) 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 cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

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