Pfizer to Present New Data on XELJANZ® for Ulcerative Colitis at UEG Week 2016

Pfizer Inc. (NYSE:PFE) announced that three abstracts for XELJANZ^® (tofacitinib citrate), being investigated in moderate to severe ulcerative colitis (UC), will be presented at the upcoming United European Gastroenterology Week (UEG Week 2016), October 15-19 in Vienna, Austria.
The tofacitinib presentations will highlight new research
results from the Phase 3 Oral Clinical Trials for
tofAcitinib in ulceratiVE colitis (OCTAVE) Induction
trials, including one oral presentation looking at the effect of prior
treatment with tumor necrosis factor inhibitors (TNFi) on efficacy
endpoints. In addition, two abstracts have been accepted as poster
presentations, highlighting results by endoscopic response, and onset of
action, respectively.
“The new data to be presented at UEG Week deepen our understanding of
the efficacy and safety profile of tofacitinib in ulcerative colitis,”
said Michael Corbo, PhD, Chief Development Officer, Inflammation &
Immunology, Pfizer Inc. “We know there is a significant unmet need in
the UC community for additional treatment options and, if approved,
tofacitinib may have the potential to offer patients and their
physicians an oral treatment option that could address these unmet needs
in the course of the disease.”
Tofacitinib is the first in a new class of medicines called Janus kinase
(JAK) inhibitors under investigation for the treatment of moderate to
severe UC. Tofacitinib is a small molecule taken as a pill. It acts on
specific inflammatory responses thought to play a role in the
inflammation associated with UC.
Tofacitinib data at UEG Week 2016 includes the following presentations:
Oral Presentation
1. Tofacitinib has induction efficacy in moderately to severely active
ulcerative colitis, regardless of prior TNF inhibitor therapy (#OP106,
Session: 504 – Future drugs in IBD, Monday, October 17, 15:45 – 17:15,
Room C)
Poster Presentations
2. Tofacitinib for induction therapy in patients with active ulcerative
colitis in two phase 3 clinical trials: results by local and central
endoscopic assessments (#P0306, Poster Session: IBD I, Monday, October
17, 10:30 – 17:00, Poster Exhibition – Hall X4 & X5)
3. Onset of efficacy of tofacitinib for induction therapy in patients
with active ulcerative colitis in two multinational, phase 3 clinical
trials (#P0842, Poster Session: IBD II Tuesday, October 18, 09:00 –
17:00, Poster Exhibition – HALL X4 & X5)
About Ulcerative Colitis
UC is a chronic, often debilitating inflammatory bowel disease that
affects millions of people worldwide.^a,b It is believed that
UC is the result of complex interactions between multiple factors that
include the environment, genetic predisposition, immune response, and
the gut microbiome in the colon or intestines.^c It can cause
abdominal pain, fever, weight loss and chronic, bloody diarrhea.^d
UC can have a significant effect on work, family and social activities.^e
In up to one-third of patients with UC, treatment is not completely
successful or complications may arise.^f Under these
circumstances, surgery to remove the colon (colectomy) may be considered.^g,h
Even after surgery, certain symptoms of UC may still persist.ⁱ
About the OCTAVE Clinical Development Program
The OCTAVE global clinical development program includes three Phase 3
studies, OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain, as
well as a long-term extension trial, OCTAVE Open. These four pivotal
studies will form the core of a submission package to regulatory
authorities for a potential UC indication.
OCTAVE Induction 1 and OCTAVE Induction 2 are two replicate Phase 3
placebo-controlled studies that evaluated induction of remission by oral
tofacitinib 10 mg twice daily (BID) in adult patients with moderate to
severe UC. Subjects must have failed or been intolerant to at least one
prior UC treatment, including corticosteroids, thiopurines or TNFi.
Positive results from OCTAVE Induction 1 and OCTAVE Induction 2 were
presented at the Congress of European Crohn’s and Colitis Organisation
(ECCO) in March 2016.
OCTAVE Sustain is a Phase 3 placebo-controlled study that evaluated oral
tofacitinib 5 mg and 10 mg BID as maintenance therapy in adult patients
with moderately to severely active UC. Positive topline results were
announced in July 2016.
OCTAVE Open is an ongoing open-label extension study designed to assess
the safety and tolerability of tofacitinib 5 mg and 10 mg BID in
patients who have completed or who have had treatment failure in OCTAVE
Sustain or who were non-responders upon completing OCTAVE Induction 1 or
2.
References available upon request
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib
citrate) extended-release
XELJANZ^®/XELJANZ XR^® (tofacitinib citrate) is a
prescription medicine called a Janus kinase (JAK) inhibitor. In the
United States, XELJANZ XR 11 mg QD is the first and only once-daily oral
JAK inhibitor approved for the treatment of moderate to severe
rheumatoid arthritis (RA) after intolerance or inadequate response to
methotrexate.
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK
innovation. XELJANZ is approved in 50 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 6,300 patients with moderate to severe RA, amounting to
more than 21,900 patient-years of drug exposure in the global clinical
development program.
XELJANZ is not approved for use by the European Medicines Agency (EMA).
A marketing authorization application for XELJANZ 5 mg BID is currently
under review by the EMA for the treatment of patients with moderate to
severe RA who have had an inadequate response or intolerance to
methotrexate.
XELJANZ is being investigated for the treatment of moderate to severe UC
and is not approved for this indication.
References available upon request
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 prescribing information for
XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: https://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,
LinkedIn,
YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of
October 15, 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 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 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; whether and when any applications for the potential
indication may be filed with regulatory authorities in any
jurisdictions; whether and when regulatory authorities in any
jurisdictions may approve such applications and/or any other
applications that are pending (including the marketing authorization
application currently under review by the EMA for the treatment of
patients with moderate to severe RA who have had an inadequate response
or intolerance to methotrexate) 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 and XELJANZ XR,
including the potential indication; 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.
¹ Loftus E. Clinical Epidemiology of Inflammatory Bowel
Disease: Incidence, Prevalence, and Environmental Influences.
Gastroenterology. 2004;126:1504–1517.
² Kappelman MD, et al. Recent Trends in the Prevalence of
Crohn’s Disease and Ulcerative Colitis in a Commercially Insured US
Population. Dig Dis Sci. 2013;58:519–525 [p519/col2/par1/ln1-2].
³ Molodecky NA, et al. Gastroenterol. 2012;142(1):46-54.
⁴ Burisch J, et al. The burden of inflammatory bowel disease
in Europe. Journal of Crohn’s and Colitis. 2013;7:322-337.
⁵ Louis E, Roughly A, Thakkar R, et al. Impact of ulcerative
colitis on patient quality of life in a real-world clinical setting.
Presented at ECCO Congress 2013, Vienna, Austria. P180. https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2013/item/p180-impact-of-ulcerative-colitis-on-patient-quality-of-life-in-a-real-world-clinical-setting.html.
[p1/results/ln7-9].
⁶ Triantafillidis J, Merikas E, Georgopoulos F. Current and
emerging drugs for the treatment of inflammatory bowel disease. Drug
Design, Development and Therapy. 2011. Available at: https://www.researchgate.net/publication/51107773.
Accessed August 11, 2015.
⁷ Landy J, Hart AL. Commentary: short-term efficacy of
tacrolimus in steroid-refractory ulcerative colitis. Alimentary
Pharmacology Therapeutics. 2013 Feb. Available at: https://www.ncbi.nlm.nih.gov/pubmed/23336680.
Accessed August 8, 2015. [P493/Col1/Par1/Ln3-6].
⁸ Travis SP, Farrant JM, et al. Predicting outcome in severe
ulcerative colitis. Gut. 1996. Available at: https://www.ncbi.nlm.nih.gov/pubmed/8984031.
Accessed August 8 2015. [P909/Col1/Par4/Ln 1-4].
⁹ Crohn’s and Colitis Foundation of America. Surgery for
Crohn’s Disease & Ulcerative Colitis. Potential long-term complications.
Available at: https://www.ccfa.org/resources/surgery-for-crohns-uc.html?referrer=https://www.google.com/.
Accessed September 7, 2016.