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Pfizer to Present New Data on XELJANZ® (Tofacitinib Citrate) for Ulcerative Colitis at UEG Week 2016Pfizer 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 (News - Alert)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 (News - Alert)). 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.
Important Safety Information
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 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 (News - Alert) at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook (News - Alert) 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: http://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: http://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: http://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: http://www.ccfa.org/resources/surgery-for-crohns-uc.html?referrer=https://www.google.com/. Accessed September 7, 2016. View source version on businesswire.com: http://www.businesswire.com/news/home/20161015005005/en/ |