Pfizer to Present New Data on Investigational Tofacitinib in Inflammatory Bowel Disease at the 11th Congress of ECCO

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) announced today that seven abstracts reporting on
new research for tofacitinib in ulcerative colitis (UC) and Crohn’s
disease will be presented at the 11th Congress of ECCO, which will be
held March 16-19 in Amsterdam, The Netherlands. Among the abstracts are
detailed results from two pivotal Phase 3 studies from the Oral Clinical
Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) program.
Tofacitinib is being studied as an investigational treatment for adult
patients with moderate to severe active UC.

“We are pleased to announce the research being presented at ECCO as it
helps advance our understanding of tofacitinib in inflammatory bowel
disease,” said Michael Corbo, Category Development Lead, Inflammation &
Immunology, Pfizer Global Innovative Pharmaceuticals Business. “Pfizer
is a leader in inflammation and immunology having discovered and
developed the only approved JAK inhibitor for RA. This new data
reinforces both our leadership position as well as our commitment to
tofacitinib as we continue to investigate its use in ulcerative colitis.”

The full list of abstracts to be presented at the 11th Congress of ECCO
follows:

Ulcerative Colitis

1. Efficacy and safety of oral tofacitinib as induction therapy in
patients with moderate to severe ulcerative colitis: results from two
phase 3 randomized controlled trials (OP019, Friday, March 18, 15:40 –
15:50)

2. Improvement in patient-reported outcomes in two phase 3 studies of
tofacitinib in patients with moderately to severely active ulcerative
colitis (P369, Friday, March 18, 12:20 – 13:20)

3. Tofacitinib plasma concentration monitoring is not needed for
optimization of induction therapy in moderate to severe ulcerative
colitis: results of pooled exposure-response analyses of phase 3
induction studies (DOP071, Friday, March 18, 18:54 – 19:01)

Crohn’s Disease

4. Efficacy and safety of oral tofacitinib for maintenance therapy in
patients with moderate to severe Crohn’s disease: results of a phase 2b
randomized placebo-controlled trial (OP021, Friday, March 18, 17:10 –
17:20)

5. Efficacy and safety of oral tofacitinib for induction therapy in
patients with moderate to severe Crohn’s disease: results of a phase 2b
randomized placebo-controlled trial (OP022, Friday, March 18, 17:20 –
17:30)

6. Effects of oral tofacitinib on patient-reported outcomes in patients
with moderate to severe Crohn’s disease: results of two phase 2b
randomized placebo-controlled trials (DOP053, Friday, March 18, 18:54 –
19:01)

7. Tofacitinib pharmacokinetics and durability of drug exposure in
moderate to severe Crohn’s disease patients in phase 2 induction and
maintenance studies (P428, Friday, March 18, 12:20 – 13:20)

About XELJANZ and XELJANZ XR

XELJANZ^® (tofacitinib citrate)/XELJANZ^® XR
(tofacitinib citrate) extended-release is a prescription medicine called
a Janus kinase (JAK) inhibitor.

As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK
innovation.

XELJANZ is approved in more than 45 countries around the world for the
treatment of moderate to severe RA as a second-line therapy after
failure of one or more disease-modifying antirheumatic drugs (DMARDs).

Pfizer is committed to advancing the science of JAK inhibition and
enhancing understanding of XELJANZ through a robust clinical development
program. The efficacy and safety profile of XELJANZ has been studied in
approximately 6,200 patients with moderate to severe RA, amounting to
more than 19,400 patient-years of drug exposure in the global clinical
development program.

XELJANZ/XELJANZ XR U.S. Label Information

XELJANZ/XELJANZ XR is a prescription medicine called a Janus kinase
(JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with
moderately to severely active rheumatoid arthritis in which methotrexate
did not work well. XELJANZ/XELJANZ XR may be used as a single agent or
in combination with methotrexate (MTX) or other non-biologic
disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ
XR in combination with biologic DMARDs or potent immunosuppressants,
such as azathioprine and cyclosporine is not recommended.

• It is not known if XELJANZ/XELJANZ XR is safe and effective in people
  with hepatitis B or C.
• XELJANZ/XELJANZ XR is not for people with severe liver problems.
• It is not known if XELJANZ/XELJANZ XR is safe and effective in
  children.

Important Safety Information

• XELJANZ/XELJANZ XR can lower the ability of the immune system to
  fight infections. Some people can have serious infections while taking
  XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused
  by bacteria, fungi, or viruses that can spread throughout the body.
  Some people have died from these infections. Healthcare providers
  should test patients for TB before starting XELJANZ/XELJANZ XR, and
  monitor them closely for signs and symptoms of TB and other infections
  during treatment. People should not start taking XELJANZ/XELJANZ XR if
  they have any kind of infection unless their healthcare provider tells
  them it is okay.
• People may be at a higher risk of developing shingles.
• XELJANZ/XELJANZ XR may increase the risk of certain cancers by
  changing the way the immune system works. Lymphoma and other cancers,
  including skin cancers, can happen in patients taking XELJANZ/XELJANZ
  XR.
• The risks and benefits of treatment should be considered prior to
  initiating XELJANZ/XELJANZ XR in patients with chronic or recurrent
  infection; who have been exposed to tuberculosis; with a history of a
  serious or an opportunistic infection; who have resided or traveled in
  areas of endemic tuberculosis or endemic mycoses; or with underlying
  conditions that may predispose them to infection.
• Viral reactivation, including cases of herpes virus reactivation
  (e.g., herpes zoster), was observed in clinical studies with XELJANZ.
• Use of live vaccines should be avoided concurrently with
  XELJANZ/XELJANZ XR. Update immunizations in agreement with current
  immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy.
• Some people who have taken XELJANZ with certain other medicines to
  prevent kidney transplant rejection have had a problem with certain
  white blood cells growing out of control (Epstein Barr
  virus-associated post-transplant lymphoproliferative disorder).
• Some people taking XELJANZ/XELJANZ XR can get tears in their stomach
  or intestines. This happens most often in people who also take
  nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or
  methotrexate.
• XELJANZ/XELJANZ XR should be used with caution in patients who may be
  at increased risk for gastrointestinal perforation (e.g., patients
  with a history of diverticulitis), or who have a narrowing within
  their digestive tract. Patients should tell their healthcare provider
  right away if they have fever and stomach-area pain that does not go
  away or a change in bowel habits.
• XELJANZ/XELJANZ XR can cause changes in certain lab test results
  including low blood cell counts, increases in certain liver tests, and
  increases in cholesterol levels. Healthcare providers should do blood
  tests before starting patients on XELJANZ/XELJANZ XR and while they
  are taking XELJANZ/XELJANZ XR, to check for these side effects. Normal
  cholesterol levels are important to good heart health. Healthcare
  providers may stop XELJANZ/XELJANZ XR treatment because of changes in
  blood cell counts or liver test results.
• Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment
  is not recommended.
• Patients should tell their healthcare providers if they plan to become
  pregnant or are pregnant.

It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. To
monitor the outcomes of pregnant women exposed to XELJANZ/XELJANZ XR, a
registry has been established. Physicians are encouraged to register
patients and pregnant women are encouraged to register themselves by
calling 1-877-311-8972.

• Patients should tell their healthcare providers if they plan to
  breastfeed or are breastfeeding. Patients and their healthcare
  provider should decide if they will take XELJANZ/XELJANZ XR or
  breastfeed. They should not do both.
• In carriers of the hepatitis B or C virus (viruses that affect the
  liver), the virus may become active while using XELJANZ/XELJANZ XR.
  Healthcare providers may do blood tests before and during treatment
  with XELJANZ/XELJANZ XR.
• Common side effects include upper respiratory tract infections (common
  cold, sinus infections), headache, diarrhea, and nasal congestion,
  sore throat, and runny nose (nasopharyngitis).

Please click the direct link to the full prescribing information for
XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

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 healthcare products. Our global portfolio
includes medicines and vaccines as well as many of the world’s
best-known consumer healthcare 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
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DISCLOSURE NOTICE: The information contained in this release is as of
March 16, 2016. 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 a potential
new indication for XELJANZ for the treatment of adult patients with
moderate to severe active UC (the “potential indication”), including its
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 clinical 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 XELJANZ may be
filed with regulatory authorities in any jurisdictions for the potential
indication; whether and when regulatory authorities in any such
jurisdictions may approve such applications, 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; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of XELJANZ and XELJANZ XR; 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, 2015 and in its subsequent reports on Form 10-Q, 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 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.

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