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November 5, 2015 8:43 am ET

One-Year Phase 3 Data for Investigational Biosimilar Candidates SB4, Enbrel (Etanercept) and SB2, Remicade (Infliximab) to be Presented for the First Time

New Pivotal 24-Week Phase 3 Data for SB5, an Investigational Biosimilar of Humira (Adalimumab), to be Reported in Late-Breaking Presentation

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that Samsung Bioepis will present new Phase 3 clinical
data for three investigational immunology biosimilar candidates at the
American College of Rheumatology (ACR) and the Association for
Rheumatology Health Professionals (ARHP) 2015 Annual Meeting in San
Francisco, Nov. 7-11.

Merck and Samsung Bioepis have a collaborative agreement to develop and
commercialize biosimilar candidates in immunology, oncology and
diabetes. These products have been designed to help meet the growing
needs of patients and healthcare systems worldwide. In September, SB4
was approved by the Ministry of Food and Drug Safety in Korea,
representing the first biosimilar product approval for Samsung Bioepis.
Under Merck’s partnership with Samsung Bioepis, MSD will market SB4 in
Korea under the brand name BRENZYS™ (etanercept).

“Patients living with rheumatoid arthritis and other chronic
inflammatory diseases are faced with many challenges,” said Dora Bibila,
general manager, Merck Biosimilars. “Through our partnership with
Samsung Bioepis, Merck is committed to commercializing biosimilar
alternatives to existing biologic therapies, and we are excited by the
opportunity to expand patient access to effective and more affordable
treatment options.”

The following Samsung Bioepis data presentations are part of the
official ACR program. Abstracts are available online through the ACR
website at www.acrannualmeeting.org.

SB4 Enbrel (etanercept) data at ACR

Abstract # 2055 – Oral Presentation: A Phase III, Randomized,
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: 52-week
Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title:
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III:
Biosimilars; Location: West – First Floor

SB2 Remicade (infliximab) data at ACR

Abstract # 2056 – Oral Presentation: A Randomized, 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: 54-Week
Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title:
Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III:
Biosimilars; Location: West – First Floor

SB5 Humira (adalimumab) data at ACR

Abstract # 8L – Late-Breaking Poster Presentation: A Phase III,
Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab
Biosimilar, with Adalimumab Reference Product (Humira) in Patients with
Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy:
24-Week Results; Tuesday, Nov. 10, 9:00 – 11:00 a.m. PST; Session
Title: ACR Late-Breaking Abstract Poster Presentations; Location:
South – Halls B-C (Poster Hall)

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]

Regulatory filings for each of these five biosimilar candidates are
expected to occur in the Merck partnered territories in the 2015-2016
timeframe.

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,
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and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’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; the company’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 the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company 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 the company’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
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