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February 5, 2014 6:40 am ET

Merck Also to Initiate Phase I “Signal Finding” Study with MK-3475 in 20 New Cancer Types

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today it has signed three separate clinical collaboration
agreements, through subsidiaries, with Amgen Inc., Incyte Corporation
and Pfizer Inc. to evaluate novel combination regimens with MK-3475,
Merck’s investigational anti-PD-1 immunotherapy. The financial terms of
the agreements were not disclosed.

“Merck clinical scientists intend to explore the potential of our PD-1
inhibitor across a wide range of cancers, both as monotherapy and in
combination,” said Dr. Roger M. Perlmutter, president, Merck Research
Laboratories. “These new collaborations with Amgen, Incyte and Pfizer
underscore our shared determination to evaluate treatment regimens with
the potential to provide meaningful benefits to patients suffering from
cancer.”

Planned investigations include:

• Pfizer and Merck will evaluate in Phase I/II clinical studies the
  safety and efficacy of MK-3475 in combination with Pfizer’s small
  molecule kinase inhibitor axitinib (INLYTA®) in patients with renal
  cell carcinoma, and separately MK-3475 plus PF-05082566 (PF-2566), an
  investigational immuno-oncology agent that targets the human 4-1BB
  receptor, in multiple cancer types.
• Incyte and Merck will collaborate on a randomized, double-blind
  placebo controlled Phase I/II study to evaluate the safety and
  efficacy of a regimen combining MK-3475 with Incyte’s investigational
  immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO)
  inhibitor, in patients with previously treated metastatic and
  recurrent NSCLC, among other advanced or metastatic cancers.
• Amgen and Merck will evaluate MK-3475 in combination with Amgen’s
  investigational oncolytic immunotherapy talimogene laherparepvec in a
  Phase I/II study in patients with previously untreated advanced
  melanoma.

Separately, Merck announced it will start a new Phase I “signal finding”
study to evaluate the safety and efficacy of MK-3475 monotherapy in 20
different PD-L1-positive solid tumor types that have not been studied
previously (clinical trials identifier: NCT02054806).

About MK-3475

Many tumors are able to evade the immune system through a mechanism that
exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an
investigational, highly selective anti-PD-1 immunotherapy designed to
restore the natural ability of the immune system to recognize and target
cancer cells by selectively achieving dual ligand blockade (PD-L1 and
PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation
of the immune system’s T-cells that target cancer, essentially by
releasing a brake on the immune system.

MK-3475 is being studied in 13 clinical trials estimated to enroll more
than 4,000 patients across more than 30 types of cancer including:
bladder, colorectal, gastric, head and neck, melanoma, non-small and
small cell lung, renal, pancreatic, prostate, triple negative and
estrogen-receptor positive HER 2-negative breast, gynecologic, and
hematological malignancies, among others. Additional trials, both as
monotherapy and in combination with other cancer therapies, are planned.
For information on Merck’s clinical trials please visit http://www.merck.com/clinical-trials/.

Breakthrough Therapy designation for MK-3475 in advanced melanoma was
granted by the U.S. Food and Drug Administration in April 2013. Merck
announced in January the initiation of a rolling submission of a
Biologics License Application for MK-3475 in advanced melanoma in the
U.S. The company expects to complete the submission in the first half of
2014.

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 connect with us on Twitter,
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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 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).

Merck
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Ian McConnell, 908-423-3046
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