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FDA Approves Xeljanz XR

Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis

February 24, 2016 -- Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors.

“Pfizer continues to be an innovator in inflammation and immunology. The introduction of the first and only once-daily oral JAK inhibitor for RA, Xeljanz XR, builds upon Pfizer’s tradition of developing patient-centered therapies,” said Michael Corbo, Category Development Lead, Inflammation & Immunology, Pfizer Global Innovative Pharmaceuticals Business.

“The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” said Dr. Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Co-Medical Director, Metroplex Clinical Research Center.

About Xeljanz and Xeljanz XR

Xeljanz/Xeljanz XR (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. Xeljanz XR 11 mg is the first and only once-daily oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA).

As the developer of Xeljanz/Xeljanz XR, Pfizer is a leader in JAK innovation. Xeljanz/Xeljanz XR do not require injections or infusions. Xeljanz/Xeljanz XR can be taken with or without methotrexate.

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 is the only JAK inhibitor included in the 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.1

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that causes a range of symptoms, including pain and swelling in the joints,2,3 particularly those in the hands, feet and knees.3 Although the exact cause of RA is unknown,3 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.3 Some people are at increased risk of developing RA, including people with a family history of RA, smokers and women.4 Three times as many women are affected by RA compared to men.3 RA affects approximately 23.7 million people worldwide5 and 1.6 million people in the United States.6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.3

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 (link is external) and @Pfizer_News (link is external), LinkedIn (link is external), YouTube (link is external) and like us on Facebook atFacebook.com/Pfizer (link is external).

DISCLOSURE NOTICE: The information contained in this release is as of February 24, 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 XELJANZ and XELJANZ XR, including their 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; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; whether and when any applications for XELJANZ or XELJANZ XR may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in other jurisdictions in which such applications are pending or will be submitted 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, 2014 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 (link is external) and www.pfizer.com.

  1. Singh, J. A., Saag, K. G., Bridges, S. L., et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology. doi: 10.1002/art.39480
  2. Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.
  3. Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2015. Available athttp://www.nlm.nih.gov/medlineplus/ency/article/000431.htm (link is external).
  4. Mayo Clinic, “Rheumatoid Arthritis.” Accessed 14 September 2015. Available at http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020/DSECTION=risk-factors (link is external).
  5. Annals of Rheumatic Diseases, “The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study.” Accessed 14 July 2015. Available at http://ard.bmj.com/content/early/2014/02/18/annrheumdis-2013-204627 (link is external).
  6. Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
  7. Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File 1.

Source: Pfizer Inc.

Posted: February 2016

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