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.
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These results will be presented for the first time at the
European League Against Rheumatism (EULAR) 16th 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
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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).
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version on businesswire.com: http://www.businesswire.com/news/home/20150610005662/en/
Merck Media:Pamela Eisele, 267-305-3558Robert Consalvo,
908-236-1127orMerck Investors:Joseph Romanelli, 908-740-1986Justin
Holko, 908-740-1879orSamsung Bioepis Media:Jamyung Cha, (82)
32-455-6137orSamsung Bioepis Investors:Sungjoon Park, (82)
32-455-6120
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