Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosim...
January 05 2017 - 8:30AM
Business Wire
Marks Pfizer’s third proposed biosimilar
pipeline molecule2 to report positive top-line data
results within the past four months
Pfizer Inc. (NYSE:PFE) today announced that the comparative,
confirmatory REFLECTIONS B538-02 study met its primary objective by
demonstrating equivalent efficacy as measured by the American
College of Rheumatology 20 (ACR20) response rate at Week 12. This
trial is evaluating the efficacy, safety, and immunogenicity of
PF-06410293 compared to Humira® (adalimumab), each taken in
combination with methotrexate, in patients with moderate to severe
rheumatoid arthritis. PF-06410293 is being developed as a potential
biosimilar to Humira.
“Today’s announcement builds on Pfizer’s robust biosimilar
pipeline which has now delivered positive top-line data results for
three of our proposed biosimilars,” said Sumant Ramachandra, MD,
PhD, MBA, Head of Research and Development, Pfizer Essential
Health. “As the leading global biosimilars company, we continue to
advance our commitment to expand access to high-quality treatment
options for patients living with chronic, debilitating conditions,
such as those in inflammation. Inflammation remains one of the
core research areas for Pfizer, spanning over 60 years and
including a number of assets in various stages of development.”
This latest data announcement represents Pfizer’s second
proposed inflammation biosimilar and the third proposed biosimilar
pipeline molecule to report positive top-line results within the
past four months. The Pfizer biosimilars pipeline consists of eight
distinct biosimilar molecules in mid to late stage development, and
several others in early stage development.
About REFLECTIONS B538-02
REFLECTIONS B538-02 is a multi-national, randomized, double
blind, two-arm, parallel group equivalence study [N=597] designed
to evaluate the safety, efficacy, and immunogenicity of PF-06410293
(a potential biosimilar to Humira® [adalimumab])versus Humira in
combination with methotrexate when administered subcutaneously to
treat patients with moderate to severely active rheumatoid
arthritis (RA) who have had an inadequate response to methotrexate
therapy. The primary endpoint is an equivalent ACR20 response (≥20%
improvement by ACR criteria) at Week 12 of study treatment.
More information about the REFLECTIONS B538-02 study can be
found at www.clinicaltrials.gov.
About PF-06410293
PF-06410293 is a monoclonal antibody (mAb) that is in
development as a potential biosimilar to Humira® (adalimumab).
Humira is currently approved in the U.S., EU and other markets
for multiple indications including rheumatoid arthritis, juvenile
idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis,
adult Crohn’s disease, pediatric Crohn’s disease, ulcerative
colitis, plaque psoriasis, hidradenitis suppurativa and
uveitis.
PF-06410293 is an investigational compound and has not received
regulatory approval in any country. Biosimilarity has not yet been
established by regulatory authorities and is not yet claimed.
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 January 5, 2017. 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
Pfizer’s biosimilars pipeline and PF-06410293, including their
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-06410293 or any other biosimilars in
development 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-06410293 or
any other biosimilars in development, 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-06410293 or any other biosimilars in
development; 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, included 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.
__________________
1 Humira® is a registered U.S. Trademark of Abbvie Biotechnology
Ltd.
2 Positive top-line results were reported for infliximab,
trastuzumab and adalimumab. Regarding infliximab, in February 2016,
Sandoz acquired the rights from Pfizer for the development,
commercialization and manufacture of PF-06438179, a proposed
biosimilar to Remicade® (infliximab), 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 in countries outside the EEA.
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Pfizer Inc.Media:Rachel Hooper, (916)
708-1868Rachel.Hooper@pfizer.comorInvestor:Ryan Crowe, (212)
733-8160Ryan.Crowe@pfizer.com
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