Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosimilar to Humira®1 (adalimumab)

NEW YORK–(BUSINESS WIRE)– 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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