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May 6, 2014 7:40 am ET

Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab

Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers

Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting

Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166)

BOSTON–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA) for MK-3475,
Merck’s investigational anti-PD-1 antibody, for the treatment of
unresectable or metastatic melanoma in patients who have been previously
treated with ipilimumab. The FDA granted Priority Review designation
with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be
reviewed under the FDA’s Accelerated Approval program. The FDA
previously granted MK-3475 Breakthrough Therapy designation for advanced
melanoma, the most dangerous type of skin cancer. If approved by the
FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a
new class of immune checkpoint modulators.

Merck also announced it plans to file a Marketing Authorization
Application for MK-3475 in Europe for advanced melanoma by the end of
2014.

“Patients with advanced melanoma have few therapeutic options and often
fail to respond to all available treatments,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories. “We are hopeful that
the FDA, through their priority review of our application, will agree to
make MK-3475 available to patients with advanced melanoma who have no
other therapeutic options.”

MK-3475 Development Ongoing in 30 Tumors, as Monotherapy and in
Combination

Today, Merck highlighted progress on the advancement of the MK-3475
development program – currently ongoing in 30 tumor types as monotherapy
and in combination. It is anticipated that by the end of 2014, the
MK-3475 development program will grow to more than 24 clinical trials
across 30 different tumor types, enrolling an estimated 6,000 patients
at nearly 300 clinical trial sites worldwide, including four new Phase 3
studies. Ongoing and planned late-stage monotherapy and combination
studies include:

• Seven Phase 3 registrational trials spanning advanced melanoma
  (adjuvant, ipilimumab-naïve, and ipilimumab-refractory), advanced
  non-small cell lung cancer (NSCLC) (previously-treated and
  previously-untreated), advanced head & neck cancer and advanced
  bladder cancer; and,
• Ten combination studies, including advanced melanoma, advanced
  NSCLC, advanced renal cell carcinoma, HER2+ breast cancer and other
  solid tumors.

Merck also said today that based on encouraging preclinical data, it
plans to initiate a Phase 1 dose-ranging study with its investigational
anti-GITR agonistic antibody, MK-4166, in patients with advanced
malignances. GITR (glucocorticoid-induced TNFR receptor) is an
activating immune checkpoint receptor, which is believed to stimulate
immune activity against cancer cells. This will be the second
investigational immune checkpoint antibody within Merck’s
immuno-oncology discovery program to enter clinical development.

Dr. Perlmutter added, “Our priority is advancing breakthrough
immunomodulatory molecules that reveal the ability of the immune system
to eliminate cancer cells. While MK-3475 provides a firm foundation for
Merck’s research and development strategy in oncology, we are also
advancing a broad pipeline of immune checkpoint agonists and
antagonists.”

MK-3475 Presentations at 2014 ASCO Annual Meeting

At the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting,
Merck will have more than 15 company-sponsored abstracts on MK-3475,
including six oral presentations. Clinical data will be presented from
studies in advanced melanoma, advanced NSCLC, as well as advanced head &
neck cancer, which is the first time data for MK-3475 will be presented
in this cancer type.

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
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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 healthcare legislation in the
United States and internationally; global trends toward healthcare 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 2013 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).

Merck
Media:
Ian McConnell, 973-901-5722
Claire Mulhearn, 908-423-7425
or
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