Pfizer Presents Positive Pivotal Data for PF-05280014, an Investigational Biosimilar to Herceptin® (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced positive findings from
REFLECTIONS B327-02 (n=707), a pivotal Phase 3 randomized, double-blind
comparative safety and efficacy study of the company’s investigational
trastuzumab biosimilar (PF-05280014) versus Herceptin^®1
(trastuzumab), at the European Society for Medical Oncology (ESMO) 2017
Congress in Madrid. Positive data from a supplemental study, REFLECTIONS
B327-04 (n=226), were also presented at the meeting. PF-05280014 is
being developed by Pfizer as a potential biosimilar to Herceptin.

“Biosimilars are poised to revolutionize the oncology treatment
landscape by expanding patient access to high quality and effective
therapies,” said Dr. Mark Pegram, associate director for clinical
research at the Stanford Comprehensive Cancer Institute, and director of
the Breast Oncology Program at the Stanford Women’s Cancer Center.
“These data are encouraging, and reinforce the future potential of
Pfizer’s investigational trastuzumab biosimilar to help meet the needs
of cancer patients and their treating physicians as a potentially lower
cost option to Herceptin, across all indications.”

The REFLECTIONS B327-02 study achieved the primary objective for
equivalence in the objective response rate (ORR) of PF-05280014 versus
Herceptin in patients receiving first-line treatment, in combination
with paclitaxel, for HER2-positive metastatic breast cancer [risk ratio
of 0.940; within the pre-specified equivalence margin of 0.8–1.25]. ORR
is defined as the proportion of patients with tumor size reduction of a
predefined amount and for a minimum period of time.²
Additionally, rates of one year progression-free survival and one year
survival were similar across groups (56% and 88.84% vs. 52% and 87.96%
for PF-05280017 and Herceptin, respectively).

The REFLECTIONS B327-04 study found there were no clinically meaningful
differences between PF-05280014 and Herceptin in terms of efficacy,
safety, immunogenicity, and noninferiority in pharmacokinetics, as
neoadjuvant treatment taken in combination with docetaxel and
carboplatin for patients with operable HER2-positive breast cancer.

“Pfizer is committed to driving significant improvements in patient care
through the development of high quality, effective biosimilars.
Including PF-05280014, Pfizer’s biosimilars pipeline consists of eight
distinct biosimilar molecules in mid to late stage development, with
three of these in oncology,” said Salomon Azoulay, MD, Senior Vice
President, Chief Medical Officer, Pfizer Essential Health. “By
continuing to grow our oncology and supportive care presence through
both novel therapies and biosimilars, we are able to provide an array of
important treatment options for patients, physicians and healthcare
systems.”

As part of Pfizer’s commitment to expanding its oncology biosimilars
pipeline, the company is progressing its biosimilar trastuzumab
marketing applications, which have been accepted for review by the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency
(EMA).

About PF-05280014

PF-05280014 is a monoclonal antibody (mAb) that is in development as a
potential biosimilar for all currently approved indications of Herceptin
(trastuzumab).

Herceptin is currently approved in the U.S., EU and other markets for
HER2-positive breast cancer and gastric cancer.

PF-05280014 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, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
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In addition, to learn more, please visit us on www.pfizer.com
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DISCLOSURE NOTICE: The information contained in this release is as of
September 10, 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 PF-05280014
and Pfizer’s proposed biosimilars pipeline, 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-05280014 or any other
biosimilars in development may be filed with regulatory authorities in
any jurisdictions other than the U.S. and the EU; whether and when the
FDA, the EMA and regulatory authorities in any such other jurisdictions
may approve any such applications for PF-05280014 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-05280014 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, 2016, 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.

__________________________

¹ Herceptin^® is a registered trademark of
Genentech, Inc.
² United States Food and Drug
Administration. Guidance for Industry: Clinical Trial Endpoints for the
Approval of Cancer Drugs and Biologics. Available at: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm071590.pdf.
Accessed October 27, 2016.

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