Merck Provides Update on Phase III Clinical Program for Preladenant, the Company’s Investigational Parkinson’s Disease

  Merck Provides Update on Phase III Clinical Program for Preladenant, the
  Company’s Investigational Parkinson’s Disease Medicine

Business Wire

WHITEHOUSE STATION, N.J. -- May 23, 2013

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today
provided an update on the clinical program for preladenant, Merck’s
investigational adenosine A2[A ]receptor antagonist for the treatment of
Parkinson’s disease (PD). An initial review of data from three separate Phase
III trials did not provide evidence of efficacy for preladenant compared with
placebo.

Based on these results, Merck is taking steps to discontinue the extension
phases of these studies and no longer plans to pursue regulatory filings for
preladenant. The decision to discontinue these studies is not based on any
safety finding. The results of these studies will be presented at an upcoming
scientific meeting and will be submitted for publication in a peer-reviewed
journal.

“While these results are disappointing, this program is an important example
of Merck’s continued commitment to pursue promising science with the goal of
bringing forward medicines that address important unmet medical needs,” said
David Michelson, M.D., vice president, clinical research, Neuroscience and
Ophthalmology at Merck Research Laboratories. “Parkinson’s disease is very
complex, making it difficult to treat patients and develop novel therapeutic
approaches. We are committed to neuroscience research and will be conducting
further analyses of the data to inform the scientific community’s efforts in
finding new approaches to treat this debilitating disease. We thank the
investigators and importantly the Parkinson’s patients who participated in the
preladenant clinical program.”

The Phase III clinical program for preladenant included three randomized,
controlled clinical trials to evaluate safety and efficacy. Two of these
studies assessed preladenant when added to levodopa therapy in patients with
moderate-to-severe PD, and one assessed preladenant as monotherapy in early
PD. More information about the preladenant Phase III clinical trials is
available on www.clinicaltrials.gov.

About Merck

Today's Merck is a global healthcare 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 consumer care 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 healthcare through far-reaching policies,
programs and partnerships. For more information, visit www.merck.com and
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Merck forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs and
expectations of Merck’s management and are subject to 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 risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of Merck’s
patents and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2012
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
(www.sec.gov).

Contact:

Merck
Media Contacts:
Pam Eisele, 908-423-5042
or
Claire Mulhearn, 908-423-7425
or
Investor Contacts:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
 
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