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June 10, 2015 7:46 am ET

Data Presented for the First Time at the EULAR Annual Meeting

Phase 1 Data for SB2, SB4 and SB5, an Investigational Biosimilar of Humira (Adalimumab), also Presented

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Samsung Bioepis Co., Ltd. today announced that pivotal Phase 3 clinical
studies of SB4, an investigational biosimilar of Enbrel (etanercept),
and SB2, an investigational biosimilar of Remicade (infliximab), met
their primary endpoints, demonstrating equivalence to the originator
medicine in patients with moderate to severe rheumatoid arthritis (RA)
despite methotrexate therapy. The primary endpoint in the two studies
was the American College of Rheumatology 20 percent response criteria
(ACR20), at week 24 and at week 30 of treatment, respectively. In these
studies, SB4 and SB2 demonstrated a safety profile equivalent to the
originator medicines.

These results will be presented for the first time at the European
League Against Rheumatism (EULAR) 16^th annual meeting in
Rome, June 10-13.

“We are excited by the positive results from these two pivotal,
head-to-head equivalence studies, which are part of the robust data
packages intended to support global regulatory filings for SB4 and SB2,”
said Christopher Hansung Ko, CEO of Samsung Bioepis. “As part of our
collaboration with Merck, we currently have five biosimilar candidates,
including SB5, an adalimumab biosimilar, in our late-stage development
pipeline.”

“Our collaboration with Samsung Bioepis to develop and commercialize
multiple biosimilar candidates in our partnered markets is making
significant progress, with five late-stage biosimilar candidates
expected to be filed with regulatory authorities around the world within
the next two years,” said Dora Bibila, associate vice president, and
general manager, Merck Biosimilars Business. “We are excited by the
opportunity to leverage the extensive capabilities of our two companies
in the emerging biosimilars marketplace to help meet the growing needs
of patients and healthcare systems worldwide.”

SB4 and SB2 Phase 3 data presented at EULAR

Samsung Bioepis conducted two randomized, double-blind, parallel group,
multicenter studies evaluating the efficacy, safety, pharmacokinetics
and immunogenicity of SB4 biosimilar etanercept and SB2 biosimilar
infliximab compared to originator Enbrel and Remicade, respectively, in
adult patients with moderate to severe rheumatoid arthritis despite
methotrexate therapy. Enbrel and Remicade are TNF inhibitors approved in
the U.S. and many other countries for the treatment of rheumatoid
arthritis and certain other indications.

In the SB4 biosimilar etanercept study, 596 patients were randomized at
70 sites in 10 countries. In this study, SB4 was shown to be equivalent
to Enbrel in terms of ACR20 response rate at week 24 of treatment in the
per-protocol set: 78.1 percent (193/247) in the SB4 arm vs. 80.3 percent
(188/234) in the Enbrel arm. The adjusted rate difference was −2.22
percent (95 percent confidence interval, −9.41 percent to 4.98 percent),
which was within the pre-defined margin (−15 percent, 15 percent).

In the SB2 biosimilar infliximab study, 584 patients were randomized at
73 sites in 11 countries. In this study, SB2 was shown to be equivalent
to Remicade in terms of ACR20 response rate at week 30 of treatment in
the per-protocol set: 64.1 percent (148/231) in the SB2 arm vs. 66.0
percent (163/247) in the Remicade arm. The adjusted rate difference was
−1.88 percent (95 percent confidence interval, −10.26 percent to 6.51
percent), which was within the pre-defined margin (−15 percent, 15
percent).

SB4, SB2 and SB5 Phase 1 data presented at EULAR

Samsung Bioepis presented results of these three randomized,
single-blind, three-arm, parallel group Phase 1 studies of SB4, SB2 and
SB5 demonstrating the pharmacokinetic (PK) equivalence of each
biosimilar candidate to its respective originator product sourced in the
U.S. and in the EU. Each of these studies also demonstrated the PK
equivalence of the U.S. and EU sourced originator products. An
equivalent safety profile to the originator product was demonstrated for
each of the three biosimilar products in each of the three studies.

About the EULAR data presentations

A Phase III, Randomised, Double-blind Clinical Study Comparing SB4, an
Etanercept Biosimilar, with Etanercept Reference Product (Enbrel) in
Patients with Moderate to Severe Rheumatoid Arthritis despite
Methotrexate Therapy (FRI0128); 12 p.m. CET, Friday, June 12, Hall 6

A Randomised, Double-blind, Phase III Study Comparing SB2, An Infliximab
Biosimilar, To The Infliximab Reference Product (Remicade) In Patients
With Moderate To Severe Rheumatoid Arthritis Despite Methotrexate
Therapy (SAT0152); 10:15 a.m. CET, Saturday, June 13, Hall 6

A Phase I Pharmacokinetic Study Comparing SB4, an Etanercept Biosimilar,
and Etanercept Reference Product (Enbrel) In Healthy Male Subjects
(SAT0176); 10:15 a.m. CET, Saturday, June 13, Hall 6

A Phase I Pharmacokinetic Study Comparing SB2, an Infliximab Biosimilar,
and Infliximab Reference Product (Remicade) In Healthy Subjects
(SAT0144); 10:15 a.m. CET, Saturday, June 13, Hall 6

A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar,
and Adalimumab Reference Product (Humira) in Healthy Subjects (FRI0110); 12
p.m. CET, Friday, June 12, Hall 6

About the Merck and Samsung Bioepis collaboration

Merck and Samsung Bioepis announced in February 2013 a collaboration to
develop and commercialize in certain partnered territories multiple
biosimilar candidates. In February 2014, the two companies expanded the
collaboration to include MK-1293, an insulin glargine biosimilar
candidate currently in Phase 3 clinical development for the treatment of
patients with type 1 and type 2 diabetes. Under terms of the agreement,
Samsung Bioepis is responsible for preclinical and clinical development,
process development and manufacturing, clinical trials and regulatory
registration, except for MK-1293, which Merck will continue to develop
and manufacture. Merck will be responsible in its partnered territories
for commercialization of all approved products resulting from the
collaboration.

The portfolio includes biosimilar candidates in immunology, oncology and
diabetes. There are five candidates in Phase 3 development [Merck
partnered territories]:

• SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]
• SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]
• SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]
• SB3 Herceptin (trastuzumab) [worldwide]
• MK-1293 Lantus (insulin glargine) [worldwide]

Each of these five biosimilar candidates is expected to be filed with
regulatory authorities around the world between 2015 and 2016.

About Samsung Bioepis

The company was established in 2012 as part of the Samsung group, with
the mission to produce affordable, high-quality biopharmaceutical
products for many patients in need. The company aims to be the world
leading biopharmaceutical company with its heritage of innovation and
advanced technologies. Please visit www.samsungbioepis.com
for more information.

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
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 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 2014 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:
Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
or
Merck Investors:
Joseph Romanelli, 908-740-1986
Justin Holko, 908-740-1879
or
Samsung Bioepis Media:
Jamyung Cha, (82) 32-455-6137
or
Samsung Bioepis Investors:
Sungjoon Park, (82) 32-455-6120