CHMP Confirms Prior Opinion Regarding Marketing Authorization in Europe for Pfizer’s XELJANZ® (tofacitinib citrate)

  CHMP Confirms Prior Opinion Regarding Marketing Authorization in Europe for
  Pfizer’s XELJANZ® (tofacitinib citrate)

  Pfizer Plans to Work with the European Medicines Agency (EMA) to Resubmit
                  Marketing Authorization Application (MAA)

Business Wire

NEW YORK -- July 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
confirmed its April 25, 2013, opinion to recommend against approval of
XELJANZ^® (tofacitinib citrate) for the treatment of adult patients with
moderate-to-severe active rheumatoid arthritis (RA). After re-examination of
the application as requested by Pfizer, the CHMP is of the opinion that
XELJANZ does not demonstrate a favorable benefit:risk profile.

While the CHMP considered that treatment with XELJANZ resulted in reduction in
the signs and symptoms of RA and improvement in the physical function of
patients, it has outstanding concerns on safety, including serious infections.

The Company is currently evaluating the feedback from the CHMP and will
determine next steps to resubmit a MAA to the EMA.

“We are disappointed in the outcome of the re-examination process. A narrow
majority of the CHMP felt there is too limited experience in the patient
population to fully characterize the profile of XELJANZ and the Committee did
not recommend approval at this time,” said Dr. Steven Romano, senior vice
president and the head of the Medicines Development Group for Pfizer Specialty
Care. “The clinical experience with XELJANZ to date, which includes data from
approximately 5,000 patients treated for RA, demonstrates a consistent
efficacy and safety profile across a range of patient types and a risk profile
that is familiar to rheumatologists who have experience utilizing the range of
treatments available to treat this disease. We believe that the benefit:risk
profile of XELJANZ is favorable, and we remain committed to working with the
EMA to make XELJANZ available to appropriate patients in Europe.”

About the Marketing Authorization Application

The MAA included data from the comprehensive, global, multi-study clinical
development program for XELJANZ, which included approximately 5,000 patients
across Phase 2 and Phase 3 trials in more than 40 countries, resulting in
7,000 patient-years of exposure at the time of regulatory submission. The
application was based on the same pivotal efficacy and safety data package
that was provided to regulatory agencies around the world.

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 and 6.2
million in Europe.^1 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.^2,3,4,5,6,7 There remains a need for additional therapeutic options.


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

XELJANZ is approved in the United States, Japan, Argentina, Kuwait, Russia,
Switzerland and the United Arab Emirates for the treatment of adults with
moderate-to-severe active RA.

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
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                                    # # #

DISCLOSURE NOTICE: The information contained in this release is as of July 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

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 and when we will resubmit a Marketing Authorization Application (MAA)
in Europe for XELJANZ for the treatment of adults with moderate-to-severe
rheumatoid arthritis and, if so, whether we will be able to address the CHMP’s
concerns to its satisfaction and receive a positive opinion from the CHMP for
that indication for XELJANZ; whether and when the European Commission will
approve any such MAA for that indication for XELJANZ; and competitive

A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K/A 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

^2 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

^3 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

^4 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.

^5 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;

^6 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.

^7 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and
adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther


Pfizer Inc.
Media Contact:
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M: 610-329-1340
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