Merck Collaborates with GlaxoSmithKline to Evaluate Novel Combination Regimen for Advanced Renal Cell Carcinoma

  Merck Collaborates with GlaxoSmithKline to Evaluate Novel Combination
  Regimen for Advanced Renal Cell Carcinoma

Business Wire

WHITEHOUSE STATION, N.J. -- December 18, 2013

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today
announced the initiation of a clinical trial to evaluate the combination of
the company’s investigational anti-PD-1 immunotherapy, MK-3475, and
GlaxoSmithKline’s orally administered kinase inhibitor, pazopanib, in advanced
renal cell carcinoma.

“Collaborations like this are central to Merck’s strategy to evaluate the
potential of MK-3475 for the treatment of cancer,” said Iain Dukes, senior
vice president, Licensing and External Scientific Affairs, Merck Research
Laboratories. “We look forward to initiating further collaborations to
investigate MK-3475 in combination with other anti-cancer agents across a
range of tumor types.”

Merck and GlaxoSmithKline entered a collaboration to study MK-3475 with
pazopanib and other agents in the GlaxoSmithKline portfolio in the future.
This Phase I/II clinical trial is designed to evaluate  the safety and
efficacy of a combination of MK-3475 and pazopanib  in treatment naïve
patients with advanced renal cell carcinoma. Further details of the
collaboration were not disclosed.

About pazopanib

Pazopanib was approved by the US Food and Drug Administration for the
treatment of patients with advanced renal cell carcinoma in October 2009 and
is marketed under the trade name Votrient®. It is now approved in more than 80
countries. For full US Prescribing Information including BOXED WARNING for
hepatotoxicity and Medication Guide, please visit:
http://www.gsk.com/products.html

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 by essentially releasing a brake on the immune
system.

MK-3475 is being studied in 10 clinical trials estimated to enroll over 4,000
patients across a broad range of cancer types, including: bladder, colorectal,
gastric, head and neck, melanoma, non-small cell lung, triple negative breast,
pancreatic, hematological malignancies and renal cell carcinoma. Additional
trials, as monotherapy and in combination with other cancer therapies, are
planned in 2014. For information on Merck’s clinical trials please visit
http://www.merck.com/clinical-trials/.

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, Facebook and YouTube.

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:
Ian McConnell, 908-423-3046
or
Claire Mulhearn, 908-423-7425
or
Investors:
Carol Ferguson, 908-423-4465
or
Justin Holko, 908-423-5088
 
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