Pfizer Provides Update on Global Regulatory Approvals and Launches of XELJANZ® (tofacitinib citrate) for the Treatment of

  Pfizer Provides Update on Global Regulatory Approvals and Launches of
  XELJANZ® (tofacitinib citrate) for the Treatment of Rheumatoid Arthritis

Business Wire

NEW YORK -- July 15, 2013

Pfizer Inc. (NYSE: PFE) announced today that tofacitinib has been approved for
the treatment of rheumatoid arthritis (RA) in patients who had an inadequate
response to existing therapies in several additional countries around the
world, including Switzerland, which is the first European country to receive
approval. Swissmedic, the Swiss agency for therapeutic products, approved
tofacitinib 5 and 10 mg twice-daily (BID) as monotherapy or in combination
with a disease modifying non-biologic antirheumatic agent (DMARD), including
methotrexate (MTX), in adult patients with moderate-to-severe active RA who
have had an inadequate response or intolerance to MTX. Tofacitinib 5 mg BID
has also been approved in Argentina, Kuwait and the United Arab Emirates, and
tofacitinib 5 mg and 10 mg BID has been approved in Russia. The brand name for
tofacitinib in the approved markets will be XELJANZ, except for Russia, where
the brand name will be Jaquinus^®.

As previously announced, XELJANZ 5 mg BID is also approved in the United
States and Japan for the treatment of moderate-to-severe active RA. XELJANZ
was launched in the United States in November 2012, and XELJANZ is expected to
be commercially available in Japan this month following approval by the
Japanese Ministry of Health, Labor and Welfare (MHLW) in March 2013. XELJANZ
will be co-promoted in Japan by Pfizer and Takeda Pharmaceutical Company
Limited. Initially, XELJANZ will be made available in Japan to medical
institutions participating in an all-patient surveillance program, designed by
Pfizer in collaboration with Japan’s Pharmaceuticals and Medical Devices
Agency (PMDA) and the Japan College of Rheumatology.

“More than 23 million people worldwide are living with rheumatoid arthritis
and there remains an unmet need for additional treatments, with up to
one-third of RA patients not adequately responding and about half who stop
responding to any particular DMARD within five years,” said Geno Germano,
president and general manager, Specialty Care and Oncology, Pfizer. “XELJANZ
has a novel mechanism of action for the treatment of moderate-to-severe RA.
With these approvals, we believe XELJANZ has the potential to change the way
rheumatologists treat this chronic, and potentially disabling, disease, and we
are proud to offer patients and physicians an additional treatment option.”

Regulatory applications for XELJANZ for the treatment of moderate-to-severe
active RA remain under review in more than 30 additional countries. In Europe,
Pfizer is seeking a re-examination of the Committee for Medicinal Products for
Human Use (CHMP) negative opinion that was announced in April, and the company
is currently working with the CHMP on the next steps in the process.

XELJANZ is the first approved RA treatment in a new class of medicines known
as Janus kinase (JAK) inhibitors. The recent marketing authorizations for
XELJANZ were based on data from the comprehensive, global, multi-study
clinical development program for XELJANZ, which included approximately 5,000
patients in more than 40 countries, resulting in 7,000 patient-years of
experience at the time of regulatory submission.

Important Safety Findings for XELJANZ

Notable safety findings observed in the XELJANZ RA program include serious and
other important infections, including tuberculosis and herpes zoster;
malignancies, including lymphoma; gastrointestinal perforations; decreased
neutrophil and lymphocyte counts; and lipid elevations. The most common
serious adverse events were serious infections. The most commonly reported
adverse events were upper respiratory tract infections, headache,
nasopharyngitis and diarrhea.

About Rheumatoid Arthritis

Rheumatoid arthritis 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 can be painful and disabling,^1 causing swelling,
stiffness and loss of function in the joints.^1 RA affects 23.7 million people
worldwide,^2 and although multiple treatments are available, up to one-third
of patients do not adequately respond, and about half stop responding to any
particular DMARD within five years.^3,4,5,6,7,8 As a result, there remains a
need for additional 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

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
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and vaccines as well as many of the world's best-known consumer health care
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who rely on us. To learn more, please visit us at

DISCLOSURE NOTICE: The information contained in this release is as of July 15,
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 we will be able to address the CHMP’s concerns to its satisfaction
regarding the Marketing Authorization Application for XELJANZ for the
treatment of adults with moderate-to-severe rheumatoid arthritis (the proposed
indication) and receive a positive opinion from the CHMP for the proposed
indication; whether and when the European Commission and regulatory
authorities in other jurisdictions will approve applications that have been or
may be submitted for the proposed indication, as well as their decisions
regarding labeling and other matters that could affect its availability or
commercial potential; uncertainties regarding the commercial success of the
proposed indication; and competitive developments.

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 Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903–911.

^2 World Health Organization, “The Global Burden of Disease, 2004 Update.”
Accessed 13 March 2012. Available at

^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:

^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.


Pfizer Inc.
Kim Bencker, 610-329-1340 (m)
Suzanne Harnett, 212-733-8009 (o)
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