Pfizer Receives CHMP Negative Opinion Regarding Marketing Authorization In Europe For Rheumatoid Arthritis Treatment XELJANZ®

  Pfizer Receives CHMP Negative Opinion Regarding Marketing Authorization In
  Europe For Rheumatoid Arthritis Treatment XELJANZ® (tofacitinib citrate)

               Pfizer Intends to Appeal and Seek Re-Examination

Business Wire

NEW YORK -- April 25, 2013

Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a negative opinion for XELJANZ^® (tofacitinib citrate) for the
treatment of adult patients with moderate-to-severe active rheumatoid
arthritis (RA). The CHMP is of the opinion that XELJANZ does not demonstrate a
favorable risk:benefit profile at this time and recommended against marketing
authorization. Pfizer intends to appeal this opinion and immediately seek a
re-examination of the opinion by the CHMP.

The Committee considered that treatment with XELJANZ resulted in an
improvement in the signs and symptoms of rheumatoid arthritis and the physical
function of patients, but did not believe that a consistent reduction in
disease activity and structural damage to joints had been sufficiently
demonstrated. The CHMP also raised questions about the serious infections,
gastrointestinal perforations and malignancies observed in XELJANZ trials.

The Marketing Authorization Application (MAA) included data from the
comprehensive, global, multi-study clinical development program for XELJANZ,
which included approximately 5,000 patients across Phase 2 and 3 trials in
more than 40 countries, resulting in 7,000 patient-years of exposure. The
application was based on the same pivotal efficacy and safety data package
that was provided to regulatory agencies around the world. XELJANZ is approved
in the United States, Japan and Russia for the treatment of adults with
moderate-to-severe active RA.

“We have confidence in XELJANZ and believe our application to the EMA
demonstrates that XELJANZ has a favorable risk:benefit profile. XELJANZ’s
safety profile is well-characterized, and the issues raised by the EMA,
including serious infections, gastrointestinal perforations and malignancies,
are familiar to rheumatologists who are experienced working with treatments
for patients to manage this difficult disease,” said Dr. Yvonne Greenstreet,
senior vice president and the head of the Medicines Development Group for
Pfizer Specialty Care. “Each regulatory authority will review and interpret
applications individually and different assessments are not uncommon. The
re-examination process will enable us to seek to address the CHMP’s questions,
and we will continue to work closely with the EMA with the goal of making this
medicine available to appropriate patients in Europe.”

About Rheumatoid Arthritis

RA is a chronic inflammatory autoimmune disease that typically affects the
hands and feet, although any joint lined by a synovial membrane may be
affected. RA affects approximately 23.7 million people worldwide^1 and 3
million in Europe.^2 Although multiple treatments are available, many patients
do not adequately respond. Specifically, up to one-third of patients do not
adequately respond and about half stop responding to any particular
non-biologic disease-modifying antirheumatic drug (DMARD) within five
years.^3,4,5,6,7,8 There remains a need for additional therapeutic options.

About XELJANZ

XELJANZ is a novel, oral Janus kinase (JAK) inhibitor for the treatment of RA.
Unlike recent therapies for RA, which are directed at extracellular targets
such as pro-inflammatory cytokines, XELJANZ takes a novel approach targeting
the intracellular pathways that operate as hubs in the inflammatory cytokine
network.

Pfizer Inc.: 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. To learn more, please visit us at www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of April
25, 2013. 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 XELJANZ (tofacitinib
citrate), including its potential benefits, that involves substantial risks
and uncertainties. Such risks and uncertainties include, among other things,
whether we will be able to address the CHMP’s concerns to its satisfaction
regarding the Marketing Authorization Application (MAA) for XELJANZ for the
treatment of adults with moderate-to-severe rheumatoid arthritis and receive a
positive opinion from the CHMP for that indication for XELJANZ; whether the
European Commission will approve the MAA for that indication for XELJANZ; 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, 2012, and in
its reports on Form 10-Q and Form 8-K.

^1 World Health Organization, “The Global Burden of Disease, 2004 Update.”
Accessed 13 March 2012. Available at
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.

^2 Lundkvist J, Kastäng F, Kobelt G. The burden of rheumatoid arthritis and
access to treatment: health burden and costs. Eur J Health Econ. 2008;8(Suppl
2):S49-60

^3 Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the
combination of etanercept and methotrexate compared with each treatment alone
in patients with rheumatoid arthritis: double-blind randomized controlled
trial. The Lancet 2004. 363: 675-681

^4 Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and
functional outcomes of treatment with adalimumab (a human anti-tumor necrosis
factor monoclonal antibody) in patients with active rheumatoid arthritis
receiving concomitant methotrexate therapy. Arthritis & Rheumatism 2004. 50:
1400-1411

^5 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in
the treatment of rheumatoid arthritis. The New England Journal of Medicine
2000. 1594-1602.

^6 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor
necrosis factor blockers in daily practice in 770 rheumatic patients. J
Rheumatol 2006; 33:2433-8.

^7 Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and
therapy-related factors that influence discontinuation of disease-modifying
antirheumatic drugs: a population-based incidence cohort of patients with
rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55.

^8 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin
Ther 2011;33(7):901-913.

Contact:

Pfizer Inc.
Media:
Victoria Davis
M: 347-558-3455
Victoria.Davis@pfizer.com
or
Investors:
Suzanne Harnett
O: 212-733-8009
Suzanne.Harnett@pfizer.com
 
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