Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Bio...
September 16 2016 - 5:24PM
Business Wire
Results confirm similar efficacy of PF-06438179
(infliximab-Pfizer) to Remicade® (infliximab), in combination with
methotrexate
Pfizer Inc. (NYSE:PFE) announced the confirmatory study
(REFLECTIONS B537-02) evaluating the efficacy, safety, and
immunogenicity of PF-06438179 (infliximab-Pfizer) compared to
Remicade® (infliximab) met its primary endpoint. The trial
demonstrated equivalent efficacy of the proposed biosimilar
PF-06438179 to the originator product as measured by the American
College of Rheumatology 20 (ACR20) response at Week 14. PF-06438179
is being developed as a potential biosimilar to Remicade.
About REFLECTIONS B537-02
REFLECTIONS B537-02 is a Phase 3, multi-national, randomized,
double blind, two-arm, parallel group study designed to evaluate
the safety, efficacy, and immunogenicity of PF-06438179
(infliximab-Pfizer) versus Remicade in combination with
methotrexate when administered intravenously to treat patients with
moderate to severely active rheumatoid arthritis (RA) who have had
an inadequate response to methotrexate therapy. This study is also
designed to evaluate clinical response, safety and immunogenicity
after study drug transitioning from Remicade to PF-06438179 after
30 or 54 weeks of Remicade treatment. The primary endpoint is ACR20
response (≥20% improvement by ACR criteria) at Week 14 of study
treatment. Evaluation at both earlier time points (Weeks 2, 4, 6,
12) and later time points (Weeks 22 and 30) will be used to support
the primary endpoint analysis. More information about the
PF-06438179 REFLECTIONS B537-02 study can be found at
www.clinicaltrials.gov.
About PF-06438179 (infliximab-Pfizer)
PF-06438179 (Infliximab-Pfizer) is a chimeric human-murine
monoclonal antibody (mAb) against tumor necrosis factor (TNF) that
is currently in development as a potential biosimilar for all
currently approved indications of Remicade (infliximab).
Remicade is currently approved in the US and EU for rheumatoid
arthritis (RA), Crohn's disease, pediatric Crohn’s disease,
ulcerative colitis, pediatric ulcerative colitis, ankylosing
spondylitis, psoriatic arthritis, and plaque psoriasis.
Biosimilarity has not yet been established by regulatory
authorities and is not yet claimed. PF-06438179 is an
investigational compound and has not received regulatory approval
in any country.
In February 2016, Sandoz acquired the rights from Pfizer for the
development, commercialization and manufacture of PF-06438179 in
the 28 countries that form the European Economic Area (EEA). Under
the terms of the divestment, Pfizer retains commercialization and
manufacturing rights to PF-06438179 (a proposed biosimilar to
Remicade) in countries outside the EEA.
About Pfizer: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us at
www.pfizer.com. In addition, to learn more, follow us on Twitter at
@Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release
is as of September 16, 2016. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments. This release
contains forward-looking information about PF-06438179, including
its potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated trial commencement and completion dates and regulatory
submission dates, as well as the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
additional analyses of existing clinical data; whether and when any
applications for PF-06438179 may be filed with regulatory
authorities in any jurisdictions; whether and when regulatory
authorities in any such jurisdictions may approve any such
applications for PF-06438179, which will depend on the assessment
by such regulatory authorities of the benefit-risk profile
suggested by the totality of the efficacy and safety information
submitted; intellectual property and/or litigation implications;
decisions by regulatory authorities regarding labeling and other
matters that could affect the availability or commercial potential
of PF-06438179; and competitive developments.
A further description of risks and uncertainties can be found
in Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2015, including in the sections thereof captioned
"Risk Factors" and "Forward-Looking Information and Factors That
May Affect Future Results", as well as in its subsequent reports on
Form 10-Q and Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at
www.sec.gov and www.pfizer.com.
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Pfizer Inc.Media:Rachel Hooper, 916-708-1868orInvestors:Ryan
Crowe, 212-733-8160
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