Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ® (tofacitinib citrate) Compared to Humira® (adalimumab)

NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) announced today top-line results from ORAL
Strategy, a Phase 3B/4 study of XELJANZ^® (tofacitinib
citrate) 5mg twice daily (BID) in the treatment of moderate to severe
rheumatoid arthritis (RA). ORAL Strategy is the first trial to compare a
JAK inhibitor as monotherapy or in combination with methotrexate (MTX)
versus adalimumab (Humira) plus MTX in MTX inadequate responders using
ACR50 at Month 6 as the primary endpoint. There were three comparisons,
which found:

• XELJANZ 5mg plus MTX met its primary endpoint in demonstrating
  non-inferiority versus Humira plus MTX
• XELJANZ 5mg monotherapy did not meet its primary endpoint of
  non-inferiority versus Humira plus MTX or versus XELJANZ plus MTX

“ORAL Strategy is representative of the type of innovative and
clinically meaningful trials that Pfizer Inflammation & Immunology
believes are important to help advance patient care and the science of
JAK inhibition,” said Michael Corbo, Chief Development Officer,
Inflammation & Immunology, Global Product Development. “We are pleased
that we demonstrated non-inferiority of XELJANZ plus MTX versus Humira
plus MTX, reinforcing the efficacy of XELJANZ combination therapy. We
will continue to analyze the monotherapy data from this study and look
forward to sharing the full results of ORAL Strategy at an upcoming
scientific forum.”

ORAL Strategy is a 12-month, double-blind, head-to-head study which
included 1,152 patients randomized into one of three study arms that
were independently compared against each other:

• XELJANZ 5 mg BID as monotherapy (n=386)
• XELJANZ 5 mg BID in combination with a weekly dose of MTX (15-25 mg)
  (n=378)
• Humira 40 mg every-other-week via subcutaneous injection in
  combination with a weekly dose of MTX (15-25 mg) (n=388)

The safety findings were consistent with the known adverse events and
serious adverse events profile for XELJANZ.

The RA clinical development program has over 20 clinical trials and
to-date represents more than 21,100 patient-years of drug exposure. The
long-term extension program, spanning over eight years of safety
experience, is one of the largest in the RA category with respect to
number of patients and patient-years of exposure.

About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib
citrate) extended-release

XELJANZ^®/XELJANZ XR^® (tofacitinib citrate) is a
prescription medicine called a JAK inhibitor. XELJANZ has been approved
for use in more than 50 countries. Since XELJANZ was first approved in
the U.S. in 2012, it has been prescribed to more than 90,000 patients
worldwide. In the United States, Argentina, and Macau, XELJANZ XR is the
first once-daily oral JAK inhibitor approved for the treatment of
moderate to severe RA.

Pfizer is committed to advancing the science of JAK inhibition and
enhancing the understanding of the efficacy and safety 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.

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
more than 150 years, Pfizer has worked to make a difference for all who
rely on us. For more information, please visit us at www.pfizer.com.
In addition, to learn more, follow us on Twitter at @Pfizer
and @Pfizer_News,
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and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of
February 16, 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 XELJANZ
(tofacitinib citrate) 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 and XELJANZ XR; uncertainties regarding
the commercial impact of the results of the ORAL Strategy trial; whether
and when any other applications for XELJANZ or XELJANZ XR may be filed
with regulatory authorities in any jurisdictions; whether and when
regulatory authorities in any jurisdictions may approve any such
applications and/or any other applications that are pending (including
the marketing authorization application currently under review by the
European Medicines Agency 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) or may be filed for XELJANZ or
XELJANZ XR, 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/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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