Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ® (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) announced today that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA)
adopted a positive opinion recommending XELJANZ^® (tofacitinib
citrate) 5 mg twice daily (BID) for the treatment of patients with
moderate to severe active rheumatoid arthritis (RA). The CHMP’s opinion
will now be sent to the European Commission (EC) for final decision. If
approved, XELJANZ in combination with methotrexate (MTX) will be
indicated for the treatment of moderate to severe active RA in adult
patients who have responded inadequately to, or who are intolerant to
one or more disease-modifying antirheumatic drugs. XELJANZ can be given
as monotherapy in case of intolerance to MTX or when treatment with MTX
is inappropriate.

“More than 2.9 million people are currently living with moderate to
severe rheumatoid arthritis in Europe. Even with multiple therapeutic
options, many of these people may not adequately respond to currently
available treatments, including methotrexate,” said Michael Corbo, Chief
Development Officer, Inflammation & Immunology, Global Product
Development. “The positive CHMP opinion for tofacitinib is an important
milestone as we work to bring this new oral treatment option to people
in the European Union living with moderate to severe active rheumatoid
arthritis.”

The marketing authorisation application (MAA) included data from the Oral
Rheumatoid Arthritis Phase 3 TriaLs (ORAL) global
development program in RA. This program consisted of six completed
clinical trials, ORAL Start, ORAL Solo, ORAL Standard, ORAL Sync, ORAL
Scan, and ORAL Step, in addition to two open-label long-term extension
(LTE) studies. At the time of the MAA submission, the ORAL development
program had accumulated more than 19,000 patient-years of drug exposure
in over 6,100 patients with follow-up observations of up to eight years
in one of the LTE studies.

Tofacitinib is part of the Janus kinase (JAK) inhibitor class of
medications. This will be a new class of medicines for the treatment of
moderate to severe active RA in the EU.

About Rheumatoid Arthritis (RA)

RA is a chronic, inflammatory autoimmune disease that causes a range of
symptoms, including pain and swelling in the joints, particularly those
in the hands, feet and knees. Although the exact cause of RA is unknown,
it is considered to be an autoimmune disease, because the immune system
in people with RA mistakes the body’s healthy tissues for a threat and
attacks them. Some people are at increased risk for developing RA,
including people with a family history of RA, smokers and women. Three
times as many women are affected by RA compared to men. RA affects
approximately 17.6 million people worldwide and more than 2.9 million
people in Europe. It can develop at any time during adulthood, but it
usually occurs between 40 and 70 years of age.

About XELJANZ (tofacitinib citrate)

XELJANZ^® (tofacitinib citrate) has been approved for use in
over 50 countries. Since tofacitinib was first approved in the U.S. in
2012, it has been prescribed to more than 85,000 patients worldwide. In
the European Union (EU), XELJANZ is an investigational medicine and has
not been approved for use.

Pfizer is committed to advancing the science of JAK inhibition and
enhancing understanding of XELJANZ through robust clinical development
programs in the treatment of immune-mediated inflammatory conditions.

XELJANZ/XELJANZ XR U.S. Label Information

XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate)
extended-release 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 US Prescribing Information for
XELJANZ/XELJANZ XR, including Boxed Warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

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DISCLOSURE NOTICE: The information contained in this release is as of
January 27, 2017. 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
indication in Europe for XELJANZ (tofacitinib citrate) 5 mg twice daily
for the treatment of moderate to severe active rheumatoid arthritis in
adult patients who have responded inadequately to, or who are intolerant
to one or more disease-modifying antirheumatic drugs. XELJANZ can be
given as monotherapy in case of intolerance to MTX or when treatment
with MTX is inappropriate (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, without limitation, the ability to meet
anticipated 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; uncertainties regarding the
commercial success of XELJANZ; whether and when the European Commission
may approve the Marketing Authorisation Application for the potential
indication and whether and when regulatory authorities in any other
jurisdictions where applications are pending or may be submitted for
XELJANZ may approve any 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 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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