Pfizer, Inc. · NYSE:PFE

Pfizer — American College of Rheumatology 2011 Analyst and Investor Meeting

31 slides from Pfizer's conference presentation, Nov 6, 2011

  1. Slide 1: American College of Rheumatology 2011 Analyst and Investor Meeting

    American College of Rheumatology 2011 Analyst and Investor Meeting November 6, 2011

  2. Slide 2: Chuck Triano, Senior Vice President, Investor Relations

    Chuck Triano Senior Vice President, Investor Relations

  3. Slide 3: Forward-Looking Statements

    Forward-Looking Statements  Our discussions during this meeting will include forward- looking statements. Actual results could differ materially from those projected in the forward-looking statements  The factors that could cause actual results to differ are discussed in Pfizer’s 2010 Annual Repor

  4. Slide 4: Geno Germano

    Geno Germano President & General Manager Specialty Care and Oncology

  5. Slide 5: RA: A Serious Disease and Growing Patient Population

    RA: A Serious Disease and Growing Patient Population  The RA market is large and growing, $12.7 billion in 2010, projected to be $17.3 billion in 20151  4.6+ million RA patients in 2010 (US, France, Germany, Italy, Spain, UK and Japan)2 » Forecasts increase to 5.2 million patients in 20192  Progr

  6. Slide 6: Tofacitinib: A Novel JAK Inhibitor

    Tofacitinib: A Novel JAK Inhibitor  Tofacitinib, a novel, oral JAK inhibitor being investigated as a targeted Cytokine immunomodulator and disease β γ modifying therapy for RA α ● Discovered by Pfizer scientists at labs in Groton, CT JAK JAK tofacitinib P P  Novel mechanism of action P P STAT STAT

  7. Slide 7: Tofacitinib in RA: The ORAL Trials

    Tofacitinib in RA: The ORAL Trials RA Clinical Trials Program is Extensive  Close to 5,000 RA patients and 5,700 patient years of exposure  Approximately 35 countries, 350 sites in the Phase 3 program ● 23% of patients in North America, 34% in Europe, 28% in Asia, 15% in Latin America  Active con

  8. Slide 8: The ORAL Trials: Pivotal Studies

    The ORAL Trials: Pivotal Studies  6-month monotherapy study in inadequate responders ORAL Solo to a DMARD (traditional or biologic) receiving (A3921045) tofacitinib monotherapy  12-month study in inadequate responders to a DMARD ORAL Sync (traditional or biologic) receiving tofacitinib and backgro

  9. Slide 9: Additional Tofacitinib Trials

    Additional Tofacitinib Trials Ongoing P3 Study ORAL Start  24-month study in MTX-naïve patients receiving tofacitinib (A3921069) monotherapy or MTX (not part of the initial registration package) Long-term Extension Studies  Phase 2/3 open label follow-up study evaluating patients who had ORAL Sequ

  10. Slide 10: Tofacitinib: Efficacy

    Tofacitinib: Efficacy In Clinical Trials to Date, Tofacitinib Demonstrated Clinically Meaningful and Statistically Significant Results, with:  Onset of action as measured by significant ACR 20 response versus placebo seen as early as 2 weeks  Improvements in signs and symptoms and disease severity

  11. Slide 11: Tofacitinib: Safety

    Tofacitinib: Safety  In clinical trials to date, tofacitinib 5 and 10 mg BID has demonstrated a consistent safety profile  Most adverse events have been mild or moderate in nature and the most frequently reported class of AEs was infections  Serious AEs, including serious infections, and adverse

  12. Slide 12: Why We're Excited About Tofacitinib's Potential

    Why We’re Excited About Tofacitinib’s Potential Powerful Efficacy in a Pill  Efficacy demonstrated across a variety of patient populations  Efficacy demonstrated alone or in combination with MTX  Improvements in signs and symptoms observed as early as two weeks Consistent Safety Profile Potential

  13. Slide 13: Next Steps: Filing

    Next Steps: Filing Based on the Safety and Efficacy Results Observed in the tofacitinib RA Clinical Development Program, Pfizer Believes the Risk/Benefit Profile Supports Regulatory Submission for Both the 5 and 10 mg Doses We Continue to Anticipate Accepted Filings in the U.S. and Europe and a Fili

  14. Slide 14: Yvonne Greenstreet

    Yvonne Greenstreet Senior Vice President, Head of Medicines Development Specialty Care

  15. Slide 15: RA Phase 3 Development Program

    RA Phase 3 Development Program 2009 2010 2011 2012 First Disclosed: MTX naive ORAL Start 1069 (CP-690,550 monotx; structure) * N=900 ORAL Scan 1044 (CP-690,550+MTX; structure) ** N=750 ACR 2011 ORAL Solo 1045 (CP-690,550 monotx) N=500 ACR 2010 DMARD IR ORAL Sync 1046 (CP-690,550+DMARD) N=750 EULAR 2

  16. Slide 16: ORAL Standard: ACR20 at Month 3

    Abstract 19572 ORAL Standard: ACR20 at Month 6 NRI (with Advancement Penalty)† 80% 70% ACR20 Response Rate 60% *** *** ** (Patients %) 50% 51.5% 52.6% 40% 47.2% 30% 20% 28.3% 10% 0% 30/106 101/196 103/196 94/199 Placebo Tofacitinib Tofacitinib Adalimumab 5 mg BID 10 mg BID 40 mg SC Q2W † Primary ana

  17. Slide 17: ORAL Scan: mTSS (Primary Endpoint)

    Abstract 19586 ORAL Scan: mTSS (Primary Endpoint) 1.5 Placebo LS Mean Change (±SE) from Baseline Tofacitinib 5 mg BID Tofacitinib 10 mg BID 1.0 0.47 0.5 0.12 0.06 * 0.0 Month 6 -0.5 * p≤0.05 vs. placebo 17

  18. Slide 18: ORAL Scan: Proportion of Non-Progressors

    Abstract 19586 ORAL Scan: Proportion of Non-Progressors mTSS Δ ≤0.5 ** * ** ** 100% 88.8% 86.9% 86.0% 86.4% 77.7% 74.1% 80% Patients (%), ±SE 60% 40% 20% 0% Month 6 Month 12 Placebo Tofacitinib 5 mg BID Tofacitinib 10 mg BID * p≤0.05; **p<0.01 vs. placebo 18

  19. Slide 19: ORAL Step: ACR Response Rates

    Abstract 19576 ORAL Step: ACR Response Rates ACR20 (Month 3) ACR50 45 60% 40 Patients, % 35 48.12% 30 *** 25 50% *** 20 *** 41.67% 15 *** * 10 ** *** 40% 5 * Patients, % 0 0 0.5 1 3 6 Months 30% 24.43% Tofacitinib 5 mg BID Tofacitinib 10 mg BID Placebo5 mg Placebo10 mg 20% ACR70 20 10% *** Patient

  20. Slide 20: Introduction to Safety

    Introduction to Safety  Pfizer has now evaluated tofacitinib in close to 5,000 patients with approximately 5,700 patient-years of exposure in a large, global program with broad geographic spread  Tofacitinib: 2,211 patient-years of exposure Exposure in  Placebo: 202 patient-years of exposure Phas

  21. Slide 21: Mortality

    Mortality Phase 3 LTE All All Tofacitinib Tofacitinib Tofacitinib Tofacitinib tofacitinib Placebo ADA tofacitinib 5 mg BID 10 mg BID 5 mg BID 10 mg BID Doses N=681 N=204 Doses N=1216 N=1214 N=1321 N=1906 N=3030 N=3227 All-cause Mortality (Including Those Occurring ≥30 Days After the Last Dose) Uniqu

  22. Slide 22: Serious Infections

    Serious Infections Phase 3 LTE All All Tofacitinib Tofacitinib Tofacitinib Tofacitinib tofacitinib Placebo ADA tofacitinib 5 mg BID 10 mg BID 5 mg BID 10 mg BID Doses N=681 N=204 Doses N=1216 N=1214 N=1321 N=1906 N=3030 N=3227 All Serious Infections Unique Patients with Events, n (%) 29 (2.4) 27 (2.

  23. Slide 23: Herpes Zoster

    Herpes Zoster Phase 3 LTE All All Tofacitinib Tofacitinib Tofacitinib Tofacitinib tofacitinib Placebo ADA tofacitinib 5 mg BID 10 mg BID 5 mg BID 10 mg BID Doses N=681 N=204 Doses N=1216 N=1214 N=1321 N=1906 N=3030 N=3227 All Herpes Zoster Unique Patients with Events, n (%) 39 (3.2) 38 (3.1) 90 (3.0

  24. Slide 24: Laboratory Changes – Summary

    Laboratory Changes – Summary Changes in Laboratory Parameters Observed for Tofacitinib 5 and 10 mg BID are Consistent Across Studies  Dose-dependent decreases in mean neutrophil counts  Dose-dependent increases in mean LDL, HDL and total cholesterol  Small increases in mean serum creatinine  Inc

  25. Slide 25: Neutrophils

    Abstract 19565 Neutrophils Neutrophil Count Mean Change From Baseline (SD) 4 in Neutrophil Count (103/mm3) 3 All tofacitinib groups (Total n=3227) 2 Tofacitinib 10 mg BID 1 (total n=1906) 0 Tofacitinib 5 mg BID -1 (total n=1321) -2 -3 -4 1 6 12 24 33 36 Month n= 1230 1035 895 634 278 122 n= 1699 870

  26. Slide 26: Hemoglobin

    Abstract 19565 Hemoglobin Hemoglobin Mean Change From Baseline (SD) 1.6 All tofacitinib groups 1.2 in Hemoglobin (g/dL) (Total n=3227) 0.8 Tofacitinib 10 mg BID 0.4 (total n=1906) 0 Tofacitinib 5 mg BID (total n=1321) -0.4 -0.8 -1.2 1 6 12 24 33 36 Month n= 1256 1051 905 642 281 123 n= 1704 871 226

  27. Slide 27: Cholesterol

    Abstract 19565 Cholesterol Total Cholesterol Mean Change From Baseline (SD) 50 in Total Cholesterol (mg/dL) 40 All tofacitinib groups 30 (Total n=3227) 20 Tofacitinib 10 mg BID 10 (total n=1906) 0 -10 Tofacitinib 5 mg BID -20 (total n=1321) -30 -40 -50 1 6 12 24 33 36 Month n= 227 1036 903 639 272 1

  28. Slide 28: Serum Creatinine

    Abstract 19565 Serum Creatinine Serum Creatinine Mean Change From Baseline (SD) 0.6 in Serum Creatinine (mg/dL) All tofacitinib groups 0.4 (Total n=3227) Tofacitinib 10 mg BID 0.2 (total n=1906) 0 Tofacitinib 5 mg BID (total n=1321) -0.2 -0.4 1 6 12 24 33 36 Month n= 1261 1045 909 644 276 121 n= 179

  29. Slide 29: Aminotransferases

    Aminotransferases  Tofacitinib caused modest, not clinically meaningful, mean elevations in ALT or AST levels  Potentially important increases (>3XULN) in liver enzymes were uncommonly observed. These increases occurred more frequently in patients on background DMARD therapy compared with monother

  30. Slide 30: Overall Conclusions

    Overall Conclusions  Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA  Extensive development program across patient populations, treatment regimens and endpoints has demonstrated what Pfizer believes is a favor

  31. Slide 31: Questions

    Questions

Pfizer — American College of Rheumatology 2011 Analyst and Investor Meeting on 6ix