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DISCLOSURE NOTICE: The information contained in this release is as of September 17, 2012. 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 that involves substantial risks and uncertainties about a potential indication for a product in development, tofacitinib, as a treatment for moderate- to -severe active RA that is under review by regulatory authorities in various markets, including the United States, Europe and Japan. Such risks and uncertainties include, among other things, (i) the uncertainties inherent in research and development; (ii) decisions by regulatory authorities regarding whether and when to approve drug applications that have been or may be filed for tofacitinib for moderate- to -severe active RA, as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and (iii) 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, 2011 and in its reports on Form 10-Q and Form 8-K. 1 van der Heijde, D. et al. Arthritis Rheum 2011; 63 (Suppl 10): S1017-1018. 2 Pfizer. (2011). Pfizer Announces Detailed Pivotal Data for Investigational Compound Tofacitinib in Rheumatoid Arthritis to be Presented at American College of Rheumatology 2011 Annual Scientific Meeting [Press release]. Available at http://www.pfizer.com/news/press_releases/pfizer_press_release.jsp?guid=20110908005788en&source=RSS_2011&page=11. 3 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 4 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File 1 5 World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available at http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. 6 Klareskog L, Van der Heijde D, de Jager J, et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. The Lancet 2004. 363: 675-681 7 Keystone, E, Kavanaugh A, Sharp J, et al. Radiographic, clinical and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. Arthritis & Rheumatism 2004. 50: 1400-1411 8 Lipsky, P, Van der Heijde, D, St. Clair, W. Infliximab and methotrexate in the treatment of rheumatoid arthritis. The New England Journal of Medicine 2000. 1594-1602. 9 Duclos M, Gossec L, Ruyssen-Witrand A, et al. Retention rates of tumor necrosis factor blockers in daily practice in 770 rheumatic patients. J Rheumatol 2006; 33:2433-8. 10 Maradit-Kremers H, Nicola PJ, Crowson CS, et al. Patient, disease, and therapy-related factors that influence discontinuation of disease-modifying antirheumatic drugs: a population-based incidence cohort of patients with rheumatoid arthritis. J Rheumatol 2006; 33(2):248-55. 11 Blum MA, Koo D, Doshi JA. Measurement and rates of persistence with and adherence to biologics for rheumatoid arthritis: a systematic review. Clin Ther 2011;33(7):901-913.