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Pfizer Announces FDA Approval Of Supplemental Application To Expand XELJANZ® (tofacitinib Citrate) Labeling To Include Additional Patient-Reported Outcomes Data For Adults With Moderately To Severely Active Rheumatoid Arthritis

DISCLOSURE NOTICE: The information contained in this release is as of November 18, 2013. 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), including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, uncertainties related to the extent of market acceptance in the U.S.; whether and when the FDA will assess the benefit: risk profile of the 10 mg twice-daily dose and the impact of XELJANZ on the inhibition of structural damage; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K/A for the fiscal year ended December 31, 2012, and in its reports on Form 10-Q and Form 8-K.

1 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

2 Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S.Census Bureau, 2010 Census Summary File 1.

3 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.

4 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.

5 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.

6 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.

7 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.

8 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.

9 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.

Copyright Business Wire 2010
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