Merck Provides Update on Odanacatib Development Program


September 2, 2016 6:00 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that it is discontinuing the development of odanacatib,
Merck’s investigational cathepsin K inhibitor for osteoporosis, and will
not seek regulatory approval for its use. Merck previously reported a
numeric imbalance in adjudicated stroke events in the pivotal Phase 3
fracture outcomes study in postmenopausal women. The company has decided
to discontinue development after an independent adjudication and
analysis of major adverse cardiovascular events confirmed an increased
risk of stroke. The data from the analysis will be presented at the
American Society for Bone Mineral Research (ASBMR) in September.

“We are disappointed that the overall benefit-risk profile for
odanacatib does not support filing or further development,” said Roger
M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “We
are very thankful to the researchers and patients who participated in
the odanacatib clinical development program. We have learned that
odanacatib treatment reduces the risk of osteoporotic fractures. At the
same time, we believe that the increased risk of stroke in our Phase 3
trial does not support further development.”

About Merck

For 125 years, Merck has been a global health care leader working to
help the world be well. Merck is known as MSD outside the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies, and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
health care through far-reaching policies, programs and partnerships.
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
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significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
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Risks and uncertainties include but are not limited to, general industry
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by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
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or delays; financial instability of international economies and
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and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2015 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (

Pamela Eisele, 267-305-3558
Teri Loxam, 908-740-1986

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