Pfizer Announces 11 Abstracts for Tofacitinib to Be Presented at the European League Against Rheumatism (EULAR) 2013 Annual Meeting

(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that 11 abstracts for
tofacitinib will be presented at the European League Against Rheumatism
(EULAR) 2013 Annual Meeting being held June 12-15 in Madrid, Spain. The
brand name for tofacitinib is XELJANZ^® (ZEL’ JANS’).

Highlights include:

Comparison of monotherapy vs. combination therapy with tofacitinib

• A meta-analysis of four Phase 3 trials (ORAL Sync, Standard, Scan and
  Solo) assessed whether there were relative differences in efficacy or
  safety between mono- and combination therapy with tofacitinib in
  patients with moderate-to-severe rheumatoid arthritis (RA) who had an
  inadequate response (IR) to disease-modifying antirheumatic drugs
  (DMARDs). The results showed no statistically significant differences
  in efficacy or safety whether tofacitinib was administered as
  monotherapy or in combination with nonbiologic DMARDs in DMARD-IR
  patients. Definitive conclusions about the relative differences cannot
  be made based on this meta-analysis and would require a randomized
  clinical trial directly comparing mono- and combination therapy.
  “Tofacitinib, an Oral Janus Kinase Inhibitor: Post-Hoc Analyses of
  Efficacy and Safety of Monotherapy Versus Combination Therapy in a
  Phase 3 Rheumatoid Arthritis Population” [Abstract #0228; Thursday,
  June 13, 2013].

Patient-reported outcome (PRO) results from Phase 3 ORAL Start study

• Results from a 12-month interim analysis of patient-reported outcomes
  from the 24-month Phase 3 ORAL Start study (A3921069) in methotrexate
  (MTX)-naïve patients with moderate-to-severe RA showed significant
  improvements in patient-reported outcomes, including pain, physical
  function and fatigue, in patients who received tofacitinib 5 mg or 10
  mg twice daily (BID) monotherapy compared to MTX. In addition, a
  significant improvement in health-related quality of life was also
  seen in the 10 mg BID group versus MTX. “Oral START: Effects of the
  Oral JAK Inhibitor Tofacitinib Monotherapy Versus Methotrexate On
  Patient Reported Outcomes in The Phase 3 Oral START Trial of Active
  Rheumatoid Arthritis” [Abstract #0258; Thursday, June 13, 2013].

An analysis of cardiovascular (CV) biomarkers from Phase 2 and 3
studies

• An analysis of three Phase 2 and 3 studies of tofacitinib explored
  changes in biomarkers relevant to lipid biochemistry and
  cardiovascular (CV) risk in moderate-to-severe RA patients treated
  with tofacitinib or placebo. The results showed that tofacitinib
  induced increases in biomarkers, including lecithin-cholesterol
  acyltransferase (LCAT) and paraoxonase, and decreases in biomarkers,
  including serum amyloid A (SAA) and high-density lipoprotein
  (HDL)-associated SAA, potentially implicating Janus kinase
  (JAK)-dependent pathways in structural and functional modifications of
  lipoprotein particles, thereby suggesting a potential for reduction in
  CV risk in patients treated with tofacitinib. Consequences on vascular
  co-morbidity require further investigation. “Effects of Tofacitinib on
  Lipid Biomarkers in Patients with Active Rheumatoid Arthritis”
  [Abstract #0137; Friday, June 14, 2013].

Analysis of lymphocyte count and risk of infection

• An analysis of the relationship between lymphocyte counts and the risk
  of infection associated with tofacitinib treatment showed lymphocyte
  counts of less than 0.5 x 1000/mm³ were infrequent but were
  associated with an increased risk of serious infections. These data
  help inform appropriate lymphocyte monitoring. “Relationship between
  Lymphocyte Count and Risk of Infection in Rheumatoid Arthritis
  Patients Treated with Tofacitinib” [Abstract #0252; Thursday, June 13,
  2013].

Additional abstracts accepted for presentation include:

• A post-hoc analysis from the Phase 3 ORAL Start study evaluating
  tofacitinib efficacy, including inhibition of structural damage, in
  patients with early RA (defined by disease duration of <6 months),
  versus MTX in MTX-naïve patients with moderate-to-severe active RA.
  “Tofacitinib Monotherapy is Effective in Methotrexate-Naïve Patients
  with Disease Duration Less Than 6 Months: A Post-Hoc Analysis of Early
  Rheumatoid Arthritis Subjects in a Phase 3 Trial” [Abstract #0225;
  Thursday, June 13, 2013].
• Efficacy and safety analysis of moderate-to-severe RA patients
  transitioning directly from adalimumab to tofacitinib in a clinical
  trial setting: “Tofacitinib, An Oral Janus Kinase Inhibitor, in a
  Rheumatoid Arthritis Open-Label Extension Study Following Adalimumab
  Therapy in a Phase 3 Randomized Clinical Trial” [Abstract #0046; Hall
  4; Thursday, June 13, 2013 at 11:20 a.m. CEST/ 5:20 a.m. EST].
• A network meta-analysis comparing efficacy and safety of tofacitinib
  relative to biologic DMARDs in tumor necrosis factor-IR patients:
  “Tofacitinib Versus Biologic Treatments In Patients With Active
  Rheumatoid Arthritis Who Have Had An Inadequate Response To Tumor
  Necrosis Factor Inhibitors -- A Network Meta-Analysis” [Abstract
  #0115; Saturday, June 15, 2013].
• Assessment of responses of two standard vaccines in RA patients
  treated with tofacitinib: “Evaluation of Influenza and Pneumococcal
  Vaccine Responses in Rheumatoid Arthritis Patients using tofacitinib”
  [Abstract #0163; Hall 8; Friday, June 14 at 10:50 a.m. CEST/4:50 a.m.
  EST].
• Comparison of tofacitinib safety between nonbiologic DMARD-IR and
  biologic DMARD-IR populations: “Tofacitinib, An Oral Janus Kinase
  Inhibitor: Safety Comparison In Patients With Rheumatoid Arthritis And
  An Inadequate Response To Nonbiologic Or Biologic Disease Modifying
  Anti-Rheumatic Drugs” [Abstract #0238; Thursday, June 13, 2013].
• Assessment of hemoglobin changes and the relationship to
  patient-reported fatigue or vitality: “Hemoglobin Changes And
  Relationship Between Anemia And Fatigue Or Vitality In Rheumatoid
  Arthritis Patients Treated With Tofacitinib” [Abstract #0241;
  Thursday, June 13, 2013].
• Human mechanistic Phase 2A study assessing how tofacitinib alters
  synovial biology and inflammatory biomarkers in RA: “The JAK Inhibitor
  Tofacitinib Suppresses Synovial JAK1-STAT1 Signaling in Rheumatoid
  Arthritis” [Abstract #0253; Friday, June 14, 2013 at 10:20 a.m.
  CEST/4:20 a.m. EST].

Safety findings observed in the overall tofacitinib RA program include
serious and other important infections, including tuberculosis and
herpes zoster; malignancies, including lymphoma; gastrointestinal
perforations; decreased neutrophil and lymphocyte counts; liver enzyme
elevations; and lipid elevations.

The most common serious adverse events were serious infections. The most
commonly reported adverse events were upper respiratory tract
infections, headache, diarrhea and nasopharyngitis.

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 disabling¹ causing
swelling, stiffness and loss of function in the joints.¹ RA
affects 23.7 million people worldwide.² 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.

About XELJANZ (tofacitinib citrate)

XELJANZ is a novel, oral Janus kinase (JAK) inhibitor for the treatment
of RA. XELJANZ is approved in the United States, Japan and Russia for
the treatment of adults with moderate-to-severe active RA with previous
treatment history, and is the first approved RA treatment in a new class
of medicines known as Janus kinase (JAK) inhibitors.

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DISCLOSURE NOTICE: The information contained in this release is as of
May 13, 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 that involves
substantial risks and uncertainties about tofacitinib, including its
potential benefits and risks as well as clinical trial data relating to
tofacitinib and the potential implications of such data. Such risks and
uncertainties include, among other things, the uncertainties inherent in
research and development, including the possibility of unfavorable
clinical trial results, including unfavorable new clinical data and
additional analyses of existing clinical data, and the need for
additional clinical studies to confirm certain results discussed in this
release; whether and when regulatory authorities in jurisdictions in
which applications for tofacitinib for the treatment of
moderate-to-severe rheumatoid arthritis are pending or will be submitted
will approve such applications as well as their decisions regarding
labeling and other matters that could affect its availability or
commercial potential; 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.