Merck & Co., Inc. today (Sep 30, 2004) announced a
voluntary worldwide withdrawal of VIOXX®
WHITEHOUSE STATION, N.J., Sept. 30, 2004—Merck & Co., Inc. today
announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib),
its arthritis and acute pain medication. The company’s decision, which is
effective immediately, is based on new, three-year data from a prospective,
randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous
Polyp Prevention on VIOXX) trial.
The trial, which is being stopped, was designed to evaluate the efficacy
of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients
with a history of colorectal adenomas. In this study, there was an
increased relative risk for confirmed cardiovascular events, such as heart
attack and stroke, beginning after 18 months of treatment in the patients
taking VIOXX compared to those taking placebo. The results for the first 18
months of the APPROVe study did not show any increased risk of confirmed
cardiovascular events on VIOXX, and in this respect, are similar to the
results of two placebo-controlled studies described in the current U.S.
labeling for VIOXX.
“We are taking this action because we believe it best serves the
interests of patients,” said Raymond V. Gilmartin, chairman, president
and chief executive officer of Merck. “Although we believe it would have
been possible to continue to market VIOXX with labeling that would
incorporate these new data, given the availability of alternative
therapies, and the questions raised by the data, we concluded that a
voluntary withdrawal is the responsible course to take.”
APPROVe was a multi-center, randomized, placebo-controlled, double-blind
study to determine the effect of 156 weeks (three years) of treatment with
VIOXX on the recurrence of neoplastic polyps of the large bowel in patients
with a history of colorectal adenoma. The trial enrolled 2,600 patients and
compared VIOXX 25 mg to placebo. The trial began enrollment in 2000.
VIOXX was launched in the United States in 1999 and has been marketed in
more than 80 countries. In some countries, the product is marketed under
the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.
Results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study,
released in March 2000, demonstrated that the risk of gastrointestinal
toxicity with VIOXX was less than with naproxen, but indicated an increased
risk of cardiovascular events versus naproxen. However, in other studies
including Merck’s Phase III studies that were the basis of regulatory
approval of the product, there was not an increased risk of cardiovascular
events with VIOXX compared with placebo or VIOXX compared with other
non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck began
long-term randomized clinical trials to provide an even more comprehensive
picture of the cardiovascular safety profile of VIOXX.
“Merck has always believed that prospective, randomized, controlled
clinical trials are the best way to evaluate the safety of medicines.
APPROVe is precisely this type of study—and it has provided us with new
data on the cardiovascular profile of VIOXX,” said Peter S. Kim, Ph.D.,
president of Merck Research Laboratories. “While the cause of these
results is uncertain at this time, they suggest an increased risk of
confirmed cardiovascular events beginning after 18 months of continuous
therapy. While we recognize that VIOXX benefited many patients, we believe
this action is appropriate.”
Merck has informed the U.S. Food and Drug Administration and regulatory
authorities in other countries of its decision. The company also is in the
process of notifying health care practitioners in the United States and
other countries where VIOXX is marketed. Patients who are currently taking
VIOXX should contact their health care providers to discuss discontinuing
use of VIOXX and possible alternative treatments. In addition, patients and
health care professionals may obtain information from www.merck.com
and www.vioxx.com, or may call (888) 36-VIOXX (1-888-368-4699).
The results of clinical studies with one molecule in a given class are
not necessarily applicable to others in the class. Therefore, the clinical
significance of the APPROVe trial, if any, for the long-term use of other
drugs in this class, consisting of COX-2 specific inhibitors and NSAIDs, is
unknown. The company will work with regulatory authorities in the 47
countries where ARCOXIA is approved to assess whether changes to the
prescribing information for this class of drugs, including ARCOXIA, are
warranted. Merck is continuing to seek approval for ARCOXIA in other
countries, including the United States.
Merck will continue its extensive clinical program to collect additional
longer-term data for ARCOXIA, its medication for arthritis and acute pain.
With regard to financial guidance, prior to today’s announcement,
Merck remained comfortable with its 2004 earnings per share guidance of
$3.11 to $3.17. The company currently expects earnings per share to be
negatively affected by $0.50 to $0.60 as a result of today’s
announcement. This estimate includes foregone sales, writeoffs of inventory
held by Merck, customer returns of product previously sold and costs to
undertake the pullback of the product. Included in this cost estimate is
the expectation of foregone fourth quarter sales of VIOXX of $700 million
to $750 million. In addition, Merck expects that worldwide approximately
one month of inventory is held by customers and will be returned.
At this point it is uncertain which of these costs will be recorded in
the third quarter and which will be recorded in the fourth quarter.
Therefore, at this point, Merck is retracting the third quarter guidance it
had previously provided.
Merck will report third-quarter earnings on Oct. 21. At that point, the
company will provide additional information regarding the costs for product
withdrawal.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical
company. Merck discovers, develops, manufactures and markets a broad range
of innovative products to improve human and animal health, directly and
through its joint ventures.
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 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,
2003, and in its periodic reports on Form 10-Q and Form 8-K (if any), which
the company incorporates by reference.
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