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
KIRKLAND, QC, KENILWORTH, N.J., and SEOUL, South Korea, June 10, 2015 /CNW Telbec/ - Merck (NYSE:
MRK), known as MSD outside Canada
and the United States, 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) 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
These two randomized, double-blind, parallel group, multicenter
studies evaluated 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 Canada for
the treatment of rheumatoid arthritis in adults 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
Results of these three randomized, single-blind, three-arm,
parallel group Phase 1 studies of SB4, SB2 and SB5 demonstrated 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 Canada and the
United States. 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 about our
operations in Canada, visit
www.merck.ca.
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SOURCE Merck Canada Inc.