wyeth J.P. Morgan 26th Annual Healthcare Conference
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wyeth J.P. Morgan 26th Annual Healthcare Conference wyeth J.P. Morgan 26th Annual Healthcare Conference Presentation Transcript

  • J.P. Morgan 26th Annual Healthcare Conference Justin R. Victoria Vice President, Investor Relations Joseph S. Camardo, M.D. Senior Vice President Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals January 8, 2008
  • Forward-Looking Statement The statements in this presentation that are not historical facts are forward- looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits, the impact of legislative and regulatory compliance and obtaining approvals, and patent, and other risks and uncertainties, including those detailed from time to time in Wyeth’s periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10- K, filed with the Securities and Exchange Commission. Quarterly results, in particular, can vary due to issues which include, but are not limited to, changes in exchange rates, the timing of actions taken by the Company to ensure long-term improvements to our manufacturing processes, the timing of regulatory approval of new products and/or facilities and the timing of promotional programs. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. 2
  • Wyeth Performance: 3rd Quarter and Nine Months 2007 - Key Financial Elements* 3Q 2007 YTD 2007 Net Revenue +9% +10% Gross Margin 73.2% 73.3% SG&A Expense +8% +4% R&D Expense +5% +9% Operating Profit +14% +18% Tax Rate 29.6% 29.3% $0.90 $2.74 Diluted Earnings Per Share +7% +10% *Adjusted to Exclude Certain Significant Item. See Press Release Issued October 18, 2007 4 View slide
  • Marketed Products Strong Performance For Nine Months 2007 Enbrel +22% $2.4 B (Amgen) $1.5 B (Wyeth) $3.9 B Effexor +1% $2.8 B Prevnar +29% $1.9 B Protonix +5% $1.4 B YTD 2007 Pharma Nutritionals +18% $1.1 B Revenue +11% Alliance Rev. 0% $973 M Zosyn +17% $845 M Biotech Premarin Biotech Now +0% $791 M Revenues +26% Represents 36% YTD 07 BeneFIX +16% $304 M of Total Pharma BMP-2 $284M +23% Revenues Rapamune +8% $265 M $0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 $4,000 $4,500 (in millions) 5 View slide
  • Key Franchises – Growth Drivers Supported by New Data * Helping Patients Live Life Less First-in-Class Pneumococcal n n Interrupted by Their Condition Conjugate Vaccine (RA, JRA, Psoriasis, Psoriatic Launched in 86 Countries n Arthritis and Ankylosing Tens of Millions of Children n Spondylitis) Immunized and Thousands of Extensive Safety/Efficacy and Lives Saved n 14 Years of Clinical Experience 6 *Source: IMS Midas Audited Sales for Enbrel – Rolling Four Quarter Period Ending 3Q07
  • Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming Key Recent FDA Pending FDA Pending Upcoming Further Trials Approvals Approval Submissions Viviant™ Aprela™ Pristiq™ Lybrel ™ Osteoporosis Prevention Menopausal Symptoms & Vasomotor Symptoms & Treatment Osteoporosis Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone Depression (I.V.) Prevnar 13v Tygacil™ Methylnaltrexone Infant (Subcutaneous) (HAP) ReFacto® AF Prevnar 13v Adult Tygacil™ (CAP) 7
  • Prevnar 13v – Expanding the Coverage Infant Adult Provide Broadest Coverage Provide First and Only Conjugate Vaccine That Offers Adults, Age Available for the Global Protection 50 and Above, an Opportunity to of Children Against Pneumococcal Opportunity Prevent Pneumococcal Disease Pneumonia for the Rest of Their Lives Phase 2 Proof of Concept Proof of Concept Achieved n n Achieved Licensing Criteria Agreed n Licensing Criteria Agreed Upon Upon n Status Worldwide Phase 3 Studies Worldwide Phase 3 Studies n n Ongoing Ongoing Submission Early 2009 Submission Late 2009 n n > $3 Billion > $1.5 Billion Peak Sales 8
  • Confidence in Future Growth New Data and Ongoing Stream of Phase IV Studies COMET Is the First in a Series of Phase IV Studies to n Be Released in the Next Few Years COMET Evaluated Enbrel/Methotrexate Combination n for Patients With Early Severe Rheumatoid Arthritis COMET Is First Major Study With Clinical Endpoint of n RA Remission COMET Demonstrated Excellent Activity to Reduce n Disease Activity, Improve Health Associated Quality of Life, and Improve Work Productivity COMET – COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis 9
  • COMET: Enbrel/Methotrexate Induces Remission and Low Disease Activity (LDA) 80 Methotrexate (n=263) Enbrel + Methotrexate (n=265) 64 * 50% 60 Remission 50 * % of Subjects 41 40 28 20 0 DAS28 Remission DAS28 LDA At One Year *p<0.001 DAS28 = Mean Disease Activity Score 10
  • Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming Key Recent FDA Pending FDA Pending Upcoming Further Trials Approvals Approval Submissions Viviant™ Aprela™ Pristiq™ Lybrel ™ Osteoporosis Prevention Menopausal Symptoms & Vasomotor Symptoms & Treatment Osteoporosis Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone Depression (I.V.) Prevnar 13v Tygacil™ Methylnaltrexone Infant (Subcutaneous) (HAP) ReFacto® AF Prevnar 13v Adult Tygacil™ (CAP) 11
  • Interferon: Escalating to R 18 MU SC TIW n = 207 A 626 Patients With N Advanced D Metastatic RCC Torisel ™: 25 mg IV QW O With Poor-Risk M n = 209 Features I Z Torisel: 15 mg IV QW E + Interferon: 6 MU SC TIW n = 210 Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research. 12
  • Allows Patients to Live Longer Primary Efficacy Analysis (446 Deaths) Interferon Torisel Interferon + Torisel Patients 209 207 210 # Deaths 143 149 152 Median Overall 10.9 mo 7.3 mo 8.4 mo Survival % Improvement in 49% 15% Survival Log Rank p-Value 0.0078 0.6965 Stratified Hudes et al. NEJM. 2007; 356: 2271-2281. Data on File, Wyeth Research. 13
  • As Important As Survival: Torisel™ Is Safe and Well Tolerated in Patients Common Side Effects: Mucositis, Anemia, n Hyperlipidemia, Rash, Infection 4Treatable and Most Often Did Not Require Dose Modification Fewer Patients Were Discontinued Due to n Side Effects Relative to Interferon (18% vs. 30%) Fewer Patients Had Serious Side Effects Relative to n Interferon (38% vs. 48%) Fewer Patients Required Dose Reduction Relative to n Interferon (20% vs. 38%) 14
  • Torisel™ Phase IV: How to Improve Outcomes in Patients Who Need Second-Line Treatment Study 404 Torisel 25 mg IV R A Weekly (n=220) N Second-Line D mRCC 1:1 O Sutent Failures M Nexavar 400 mg I PO bid (n=220) Z E Global Trial With Patient Enrollment In U.S. Sites Currently Underway 15
  • Torisel™ Has Significant Potential for Expanded Medical Impact and Growth Torisel Is the Only New Drug for Renal Cell Cancer n Proven to Extend Survival n Study 404 in Second-Line Sutent Failures Currently Enrolling 4Data Will Be Available in 2009 4Second-Line Use Represents ~50% of Projected 2010 Sales Registration for Mantle Cell Lymphoma Was Submitted n in Europe in December 2007 Torisel Peak Sales > $500 Million 16
  • Torisel™ Will Be Followed by Other New Drugs From the Strong Oncology Pipeline Phase 3 Started for Two Products in December 2007 n 4CMC-544: Targeted Calicheamicin Conjugate for Follicular Lymphoma 4SKI-606 (Bosutinub): Targeted Kinase Inhibitor for Chronic Myelogenous Leukemia - This Is a Comparative Study With Gleevec for First-Line Treatment Phase 2 Is Completing for Next Oncology Product n 4HKI-272: New Kinase Inhibitor for Breast Cancer 17
  • Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming Key Recent FDA Pending FDA Pending Upcoming Further Trials Approvals Approval Submissions Viviant™ Aprela™ Pristiq™ Lybrel ™ Osteoporosis Prevention Menopausal Symptoms & Vasomotor Symptoms & Treatment Osteoporosis Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone Depression (I.V.) Prevnar 13v Tygacil™ Methylnaltrexone Infant (Subcutaneous) (HAP) ReFacto® AF Prevnar 13v Adult Tygacil™ (CAP) 18
  • Pristiq™ Is Effective for Treating Depression at 50mg HAM-D17 - Adjusted Mean Total Scores Over Time Study 333 25 Placebo DVS SR 50 mg DVS SR 100 mg Adjusted Mean Total Score 20 Final 15 (LOCF) a,b 10 a : p-Value DVS 50mg vs. placebo <= 0.05 b : p-Value DVS 100mg vs. placebo <= 0.05 a,b a,b a,b 0 2 4 6 8 Endpoint Time (Weeks) Presented December 12, 2007 19
  • Pristiq™: Nausea Is Limited to the Early Part of the Treatment Period Study 333 25 Placebo % Patients Reporting Nausea as Treatment DVS SR 50 mg 20 DVS SR 100 mg Emergent Adverse Event 15 10 5 0 Day 1-7 Day 8- Day 15- Day 22- Day 29- Day 43- Day > Post 14 21 28 42 56 56 study 20
  • Pristiq™ Tolerability – Nausea Nausea - Tolerability Issue Common to SNRI Class n n Occurs in About 1/5 of Patients Treated with Pristiq 50 mg – Low Rate 4Nausea Incidence in Combined Study Data for 50 mg Is 22% (vs. 11% Placebo) - Two Low Dose (50 mg) Fixed Dose Studies 4Compared to Nausea Incidence of 35% to 41% in Previously Reported Fixed Dose Studies 100 to 400 mg Nausea Is Mostly Mild or Moderate n n Abates in About One Week n Does Not Lead to Excess Discontinuation of Therapy n Allows Patients to Tolerate the Drug and Get the Antidepressant Benefit of the Treatment 21
  • Low Dose Program for Pristiq™ – A Strong Addition to the NDA Database for Launch Efficacy n 4Replicate Evidence of Efficacy at 50 mg and 100 mg 4Efficacy Observed As Early As Week 4 for Both Doses - Comparable to Current Antidepressant Therapy Safety n 4Reduced Adverse-Event Related Discontinuation Withdrawal Rates Compared With Higher Doses 4Improvement in Incidence of Nausea and Overall Tolerability 4No New Safety Signals Seen in Labs, Vital Signs or ECG Parameters Pristiq MDD NDA Action Date – End February 2008 22
  • Wyeth’s Current/Near Term Opportunities: Approved, in Review and Upcoming Key Recent FDA Pending FDA Pending Upcoming Further Trials Approvals Approval Submissions Viviant™ Aprela™ Pristiq™ Lybrel ™ Osteoporosis Prevention Menopausal Symptoms & Vasomotor Symptoms & Treatment Osteoporosis Torisel ™ Pristiq™ Bifeprunox Methylnaltrexone Depression (I.V.) Prevnar 13v Tygacil™ Methylnaltrexone Infant (Subcutaneous) (HAP) ReFacto® AF Prevnar 13v Adult Tygacil™ (CAP) 23
  • Methylnaltrexone: Significant Unmet Medical Need in Opioid Induced Constipation and Post Operative Ileus Opioid Induced Constipation (OIC) A Common Side Effect That Can Be a Barrier to Effective Pain n Management First Indication for Methylnaltrexone Will Be for Treatment of OIC n in Patients Receiving Palliative Care Studies Ongoing for OIC Patients With Chronic Non-Malignant n Pain, and for Shorter Term Acute Pain That Requires Opiates, e.g. Post-Operative OIC in Orthopedic Surgical Patients Post Operative Ileus (POI) A Complication of Surgery That Delays Recovery and Can Extend n Hospital Stay No Medicines Approved to Treat POI n 24
  • Importance of Opiates for Pain Creates Substantial Opportunity for Innovative New Product In U.S. 5 Million Patients Have Opioid Induced Constipation >40% Patients ~12M Patients OIC Continuous or Population Experience Long-Term Use† (Est.) OIC 4.6M 5.0 Continuous Use Million Patients 7.2M Long-Term Use (Wyeth Estimates) † Longitudinal Patient Data – Opioid Use Days Per Annum: Short -Term = <60 days, Long-Term = 61 – 300 days, & Continuous = 300+ days 25
  • Methylnaltrexone Is a Peripherally Selective Opioid Antagonist CH3 Opioids Activate Receptors Morphine Acts Centrally in the Brain and Provide n Pain Relief… N and Peripherally Morphine n Methylnaltrexone Is a Mu Opioid Receptor Antagonist HO O OH n Does Not Cross the Blood-Brain Barrier n Antagonizes Peripheral, CH3 but Not Central Opioid Receptors Methylnaltrexone N+ n Reverses Opioid Induced Constipation Without HO Reversing Analgesia or Inducing Withdrawal … But Receptor Activation in the GI Tract Results in HO O O Constipation. 26
  • Methylnaltrexone Is Effective in Relieving Constipation in Patients Who Need Opiates >50% of Patients Have Bowel Movement Within 4 Hours (Study 301) 70 Subcutaneous Methylnaltrexone % Patients Having Bowel Movement 60 50 40 30 20 10 0 Placebo 0.15 mg/kg 0.30 mg/kg Recommended Dose 27
  • Methylnaltrexone Induces a Rapid and Predictable Response in OIC Study 301 Subcutaneous Methylnaltrexone 75% 30 minutes 0.30 mg/kg % Patients Having Bowel Movement 0.15 mg/kg 50% 25% Placebo 0% 0 4 1 2 3 5 Hours Recommended Dose 28
  • Methylnaltrexone IV Accelerates Recovery in Post Operative Ileus (POI): Phase 2 Data 65 Patients With Segmental Colectomies n Randomized to Methylnaltrexone IV or Placebo n Evaluated for Clinical Signs Indicating Recovery of Bowel Function and n Readiness for Discharge Acceleration Time to Post-operative Recovery Endpoint (On Average) Tolerance of First Solid Meal (p=0.12) 25 Hours First Bowel Movement (p=0.01) 23 Hours Discharge Eligibility 30 Hours (p=0.03) Actual Discharge 25 Hours (p=0.09) Discharge a Day Early 29
  • Methylnaltrexone: Status Summary Subcutaneous Product for Palliative Care n 4NDA Action Date January 30, 2008 4European Marketing Application Submitted May 2007 Intravenous Phase 3 Studies To Complete in 1Q08 n 4Two Studies of Post Operative Ileus 4NDA Submission Planned For Mid 2008 Oral Formulation – Phase 2 n 4Two Studies in OIC Patients with Chronic Non-Malignant Pain Additional Phase 3 and Phase 4 Studies for n Subcutaneous Product in OIC 4Chronic Non-Malignant Pain 4Post-Operative OIC in Orthopedic Surgical Patients 30
  • Wyeth R&D: New Drugs With Important Indications Launched: Tygacil® Complicated Skin & Abdominal Infections Torisel™ Renal Cell Cancer Lybrel™ Contraception Late Stage Pipeline Includes: Pristiq ™ Major Depressive Disorder Viviant™ Prevention/Treatment Osteoporosis Methylnaltrexone SC – Opioid Induced Constipation IV – Post Operative Ileus Tygacil® CAP/HAP Aprela ™ Menopausal Symptoms/Osteoporosis Pristiq ™ Menopausal Symptoms Prevnar 13 Infant/Adult Invasive Pneumococcal Disease Bifeprunox Schizophrenia Maintenance Bapineuzumab Alzheimer’s Disease 31
  • Wyeth R&D: New Drugs With Important Indications Launched: Tygacil® Complicated Skin & Abdominal Infections Torisel™ Renal Cell Cancer Lybrel™ Contraception Late Stage Pipeline Includes: Pristiq ™ Major Depressive Disorder Viviant™ Prevention/Treatment Osteoporosis Methylnaltrexone SC – Opioid Induced Constipation IV – Post Operative Ileus Tygacil® CAP/HAP Aprela ™ Menopausal Symptoms/Osteoporosis Pristiq ™ Menopausal Symptoms Prevnar 13 Infant/Adult Invasive Pneumococcal Disease Bifeprunox Schizophrenia Maintenance Bapineuzumab Alzheimer’s Disease 32
  • Bapineuzumab Phase 3 for Alzheimer’s Disease Four Studies in Over 4,000 Patients Are Beginning n Worldwide 4First U.S. Patient Enrolled December 2007; International Studies to Initiate Early 2008 4Patients Are Stratified by APO E-4 Carriers vs. Non-Carriers 4APO E-4 Carriers - 0.5mg/kg vs. Placebo - Minimize Occurrence of Vasogenic Edema 4APO E-4 Non-Carriers - 0.5 mg/kg, 1.0 mg/kg and 2.0 mg/kg vs. Placebo Co-Primary Efficacy Endpoints – Validated Cognitive n and Functional Scales 4Other Cognitive, Functional, Behavioral, Biomarkers, Health Outcomes Endpoints Phase 2 Data Mid-2008 n 33
  • Conclusion Strong Growth Drivers in the Market n Successful New Product Launches n A Series of New Products Pending Approval n Innovative Therapies in Development To Address A Number n of High Unmet Medical Needs with Significant Commercial Potential 34