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wyeth JPMorgan 25th Annual Healthcare Conference
1. J.P. Morgan 25th Annual
Healthcare Conference
Joseph S. Camardo, M.D.
Senior Vice President Global Medical
Affairs and North American Medical
Director, Wyeth Pharmaceuticals
January 9, 2007
2. 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
3. 7 New Drugs - 11 Important Indications
(October 5, 2006 Analyst Meeting)
Today’s
Talk
Pristiq™ Major Depressive Disorder
Pristiq™ Major Depressive Disorder
Vasomotor Symptoms
Vasomotor Symptoms
Viviant™ Prevention/Treatment Osteoporosis
Viviant™ Prevention/Treatment Osteoporosis
Aprela™ Menopausal Symptoms/Osteoporosis
Aprela™ Menopausal Symptoms/Osteoporosis
Lybrel™ Contraception
Lybrel™ Contraception
Torisel™ Renal Cell Cancer
Torisel™ Renal Cell Cancer
Mantle Cell Lymphoma
Mantle Cell Lymphoma
Bifeprunox Schizophrenia
Bifeprunox Schizophrenia
Methylnaltrexone SC – Opioid Induced Constipation
Methylnaltrexone SC – Opioid Induced Constipation
IV – Post Operative Ileus
IV – Post Operative Ileus
Tygacil®* CAP/HAP
Tygacil®* CAP/HAP
* Tygacil already approved, not a new drug
3
6. Increasing Impact of Prevnar® in U.S.
…in Children … and Adults
(>50 Years of Age)
Average Incidence of Vaccine Serotype
90 35
Prelicensure Prelicensure
80 30
(1998-1999) (1998-1999)
IPD per 100,000 Population
Estimated Cases/100,000
70 Postlicensure Postlicensure
25
60 (2003) (2002-2003)
55%
20
50
40 Reduction
15
94%
30
10
Reduction
20
5
10
0 0
Average for 2003 Average for 2003
1998 and 1999 1998 and 1999
MMWR. 2005;Vol: 54(No. 36):893-897.
6
7. The Infant Vaccine Phase 3 Program
Prevnar 13
Objectives:
n
Demonstrate the Immunological Non-Inferiority of 13v PnC to 7-valent
Prevnar® in Young Infants
Demonstrate That 13v PnC Does Not Interfere With Immune
Responses Elicited by Concomitantly Administered Childhood
Vaccines
Demonstrate Immunological Consistency Across Multiple Production
Batches of the Vaccine
Demonstrate the Vaccine’s Safety and Tolerability
The Program Will Involve Approximately 4,000 Children
n
7
8. 13v PnC Infant Product Profile
The Most Complete Vaccine Available for the
Global Prevention of Pneumococcal Disease
and Otitis Media
Phase 2 Proof of Concept Achieved
n
Licensing Criteria Agreed Upon
n
Status Worldwide Phase 3 Studies
n
Ongoing
Submission – Early 2009
n
8
9. The Adult Vaccine Phase 3 Program
Prevnar 13
Five Key Objectives:
n
Demonstrate robust Immunological responses for 13v PnC in adults >50
Years of Age
Demonstrate That 13v PnC Can Enhance the Anti-Polysaccharide
Responses in Adults Previously Immunized With the 23-valent Vaccine
Demonstrate That Initial Immunization With 13v PnC Does Not Cause
Immunological Hyporesponsiveness
Demonstrate That 13v PnC Does Not Interfere With the Immune
Response to Concomitantly Administered Influenza Virus Vaccine
Demonstrate the Vaccine’s Safety and Tolerability
The Program Will Involve Approximately 3,200 Adults
n
9
10. 13v PnC Adult Product Profile
The Vaccine of Choice for Adults 50 Years
of Age and Older for the Prevention of
Pneumococcal Disease
Proof of Concept Achieved
n
Licensing Criteria Being Finalized
n
Status Worldwide Phase 3 Clinical
n
Studies to Begin in Early 2007
Submission 2009
n
10
12. Pristiq™: A Single Product With Two
Indications
Pristiq
Vasomotor Symptoms
Depression
Positioning Positioning
First Line Treatment of First FDA-Approved
Major Depressive Disorder Non-Hormonal Treatment of
Associated With Menopause Moderate-to-Severe VMS
12
13. Pristiq™/Effexor XR®
Comparable MDD Efficacy
Pooled Post-Hoc Analysis
0
-2
-4
Change from Baseline
Ham-D 17 Total
-6 Pristiq 200-400 mg
-8
* * Placebo
-10
* Effexor XR
* 75-150 mg
-12 * **
Effexor XR
150-225 mg
*
-14 * *
*
-16
1 2 3 4 5 6 7 8
Week
* P < 0.05 vs placebo
DVS 309-EU and 317-US: Pooled Analysis Ham-D17 Total Score (Mixed Effect Model, ITT)
13
14. Pristiq™: Effective in Reducing
Number of Moderate and Severe VMS
Study 315 Study 319
13 13
12 12
11 11
10 10
# of Flushes
9
# of Flushes
9
8 8
Placebo
Placebo
7 7
6 6
Pristiq
150 mg
5 5 Pristiq 100 mg
Pristiq
4 4
100 mg
Pristiq 150 mg
3 3
2 2
0 1 2 3 4 56 7 8 9 10 11 12 0123 45 678 9 10 11 12
Weeks
Weeks
100 mg dose: p-value versus placebo < 0.05 at all time points
150 mg dose: p-value versus placebo < 0.05 at all time points
14
15. Pristiq™: Safety and Tolerability Profile
Consistent With the SNRI Class
Asthenia Nervousness
Hypertension Somnolence
Anorexia Tremor
Constipation Sweating
Dry Mouth Abnormal Vision
Nausea Mydriasis
Vomiting Abnormal Ejaculation/Orgasm
Impotence (Male)
Dizziness
Insomnia
(Adverse Reactions ≥ 5%)*
*Most common adverse drug reactions (>5%), pooled data VMS+MDD
15
16. Pristiq™ Low-Dose Program
MDD
3 Ongoing Low-Dose Studies
n
50, 100 mg, Placebo (2 Studies U.S., EU)
50, 100 mg, Placebo, Duloxetine
1 Low-Dose Study to Support Registration in Asia
n
Additional Low-Dose Drug-Drug Interaction Studies
n
Underway
VMS
Titration Study – 25, 50, 100 mg (Ongoing)
n
16
17. Pristiq™ Will Broaden the Reach of Our SNRI
Franchise
Vasomotor Major
Vasomotor Major Fibromyalgia
Fibromyalgia
Depressive
Symptoms of Depressive
Symptoms of Syndrome
Syndrome
Menopause Disorder
Menopause Disorder
Generalized
Generalized
Anxiety
Anxiety
Disorder
Disorder
Social
Social
Anxiety
Anxiety
Green = Effexor XR® Disorder
Disorder
Blue = Pristiq™
Panic
Panic
Disorder
Red = Effexor/Pristiq Disorder
17
18. Pristiq™ Product Profile for Major Depression
or VMS
Can Become the First and Only SNRI Proven
to Effectively Address the Distinctive
Symptoms and Therapeutic Needs of Women
With Depression Associated With
Menopause or Vasomotor Symptoms
MDD NDA Dec 2005
Status
VMS NDA June 2006
18
19. Viviant™/Aprela™
(Bazedoxifene) and
(Bazedoxifene/Conjugated
Estrogens)
Alliance with Ligand Pharmaceuticals
20. Viviant™ Product Profile
(Bazedoxifene)
To Be the First New SERM in Nearly 10
Years Providing Physicians a New Option
for Patients at Risk of Osteoporosis and
Fracture
20
21. Viviant™ Prevents Osteoporosis
Lumbar Spine BMD
Phase 3 Study
1.00
Viviant 40 mg
Adjusted Percent Change
Raloxifene 60 mg
0.00
Viviant 20 mg
Placebo
Viviant 10 mg
-1.00
-2.00
Baseline Month 6 Month 12 Month 18 Month 24
p <0.001 vs. placebo for all BZA groups at each time point
No statistically significant differences among BZA 10, 20, 40 mg at any time point
21
22. Viviant™: Analysis of Endometrial Effects
Includes Clinically Significant Endometrial
Thickness, Hyperplasia, Polyp, and Carcinoma
% Patients With Endometrial Treatment
5
Emergent Adverse Events
4
3
2
*
*
1
0
Viviant ™ 10
Placebo Viviant 20 Viviant 40 Raloxifene 60
* Statistically significant to RLX and PCB
22
23. Viviant Clinical Profile
Achieved Osteoporosis Prevention As Measured
n
by BMD
Good Endometrial Safety Profile
n
No Increase in Hyperplasia, Polyps, or Thickness
Side Effect Profile: Increase From Placebo
n
Hot Flush
Venous Thrombosis
Leg Cramps
Less Breast Tenderness Versus Placebo
n
23
24. Aprela™: Optimal Targeted Response of
Tissue Selective Estrogens Complex (TSEC)
Target TSEC
Increased Bone Mass
Improved Hot Flush
Vaginal Health
Prevent Endometrial Hyperplasia
Decreased Breast Tenderness
The Most Comprehensive Medicine
for Menopause
24
25. Aprela™ Prevents Osteoporosis
Lumbar Spine BMD
Phase 3 Study
2.0
*
*
Aprela 20/0.625
1.5 *
*
* Aprela 20/0.45
1.0
* *
Adjusted Mean % Change
0.5
*
0.0
Raloxifene
-0.5
-1.0
Placebo
-1.5
BMD Change Relative to Placebo:
-2.0 20/0.625: ↑ 3.72% at 2y
20/0.45: ↑ 3.61% at 2y
-2.5
Baseline Month 6 Month 12 Month 18 Month 24
p vs PBO ≤ 0.001 (all BZA/CE groups at 6, 12, 18 and 24m)
* p vs RAL < 0.05
25
26. Aprela™ Effectively Treats Vasomotor
Symptoms
Number of Moderate-to-Severe Symptoms
Phase 3 Study
0
Placebo
-2
Adjusted Mean Change
From Baseline
Raloxifene
-4
-6
Aprela 20/0.625
-8
Aprela 20/0.45
-10
0 1 2 3 4 5 6 7 8 9 10 11 12
Week
Statistically significant at all end points vs placebo and 8 – 12 weeks vs raloxifene
Data on file: Ph 3 BZA/CE analysis 3115A1-303 study
26
27. Aprela™ Bleeding Profile - No Breakthrough
Bleeding
% Subjects With Amenorrhea Over 1 Year
Comparison to Prempro™ by Historical Data
100%
80%
60%
Placebo
40% Aprela™ 20/0.625
Aprela 20/0.45
20% CE/MPA 0.45/1.5
CE/MPA 0.625/2.5
0%
1 2 3 4 5 6 7 8 9 10 11 12 13
Months
Data on file: Ph 3 BZA/CE analysis 3115A1-303 study
27
28. Aprela™ Provided Excellent Endometrial and
Breast Safety/Tolerability - Phase 3
After 2 Years of Treatment With Aprela
n
Endometrium
- No Difference From Placebo
- Endometrial Hyperplasia
- Endometrial Thickness
- Endometrial Polyps
Breast
- No Difference in Breast Tenderness vs. Placebo
- No Difference in Breast Tenderness vs. Raloxifene
- No Increased Breast Cancers
28
29. Aprela - The First TSEC
A New Class for Menopausal Treatment
Product Profile
n
Relieves Vasomotor Symptoms
Prevents Osteoporosis
Improves Vulvovaginal Atrophy (VVA)
Excellent Amenorrhea
Less Breast Tenderness
Provides Endometrial Protection Without Progestin
NDA Filing: Late 2007
n
Most Significant Medical Advance
in Menopausal Therapy
29
32. Torisel™ Is the First New Drug Shown to
Significantly Improve Survival in RCC
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
Based on Data for Wyeth NDA
32
33. Overall Survival Extended by More Than 3
Months With Torisel™
1.00
From
ARCC Study
Survival Distribution
0.75
Torisel
Function
0.50
IFN
0.25
7.3 mo 10.9 mo
0.00
0 5 10 15 20 25 30
Time to Death (Months)
33
34. Patients on Torisel™ Live Longer and
Maintain Quality of Life
10 *
Torisel
8 * Interferon
Torisel
Months
6
Interferon
4
2
0
TWiST Q-TWiST
Torisel Extends Time Without Symptoms of Progression or Toxicity
* Torisel significantly better, p=.0005
34
35. Torisel™ Is Unique Among the New RCC Drugs
Torisel Nexavar Sutent
(Current Indication)
Study 1st Line Poor/ Intermediate 2nd Line Good/ 1st Line Good/
Population Prognosis Intermediate Prognosis Intermediate Prognosis
N = 769 Patients N=750
N = 626 Patients
Comparator Interferon Placebo Interferon
Survival No Significant No Significant
49% Improvement
Improvement Improvement
10.9 vs. 7.3 Months
Progression- 77% Improvement 99% Improvement 120% Improvement
free Survival 5.5 vs. 3.1 Months 5.9 vs. 2.8 Months 11 vs. 5 Months
35
36. Torisel™ Is a Unique and Effective
New Treatment for Renal Cell Cancer
Only Agent to Show an RCC Survival Benefit
Torisel Alone Improves Overall Survival (49%) in
n
Patients With Advanced Renal Cell Cancer
Median Increase in Survival Is 3.6 Months
The Result Is Clinically Significant and Highly Statistically Significant
Effective in Patients With Poor and Intermediate Prognosis
Torisel Also Preserves Patients’ Quality of Life
n
Positions Torisel to Be RCC Drug of Choice
36
38. Bifeprunox: Study 10214 Efficacy
1.0
0.9
0.8
Kaplan-Meier Estimates
Bifeprunox 30 mg
0.7
0.6
0.5 Bifeprunox 20 mg
0.4
0.3 Placebo
0.2
p-Value = 0.008
0.1
0.0
0 30 60 90 120 150 180
Time in Days
Bifeprunox Patients Remained Relapse-Free Longer
Than Placebo Patients Over 6 Months
38
39. Bifeprunox: Study 10214 Safety
Mean Weight Change
Weight Change From Baseline (Lbs)
0
-1
-2
-3
*
-4
-5
Placebo Bifeprunox 20 mg Bifeprunox 30 mg
Bifeprunox Patients Lost Weight on Average
After 6 Months
* p < 0.05 bifeprunox versus placebo
39
40. Bifeprunox: Study 10214 Safety
% Patients with Metabolic Syndrome
50%
40%
30%
End of
Baseline
Study End of
Baseline
20% Study
End of
Baseline
Study
10%
0%
Placebo Bifeprunox 20 mg Bifeprunox 30 mg
Bifeprunox Did Not Cause Metabolic Syndrome
Definition of assessable: 4 or more MS criteria have been measured
MS present: 3 or more MS criteria are fulfilled
40
41. Bifeprunox Safely Maintains Stability
in Schizophrenia
Relief for Patients Where Metabolic Changes
n
Have Challenged Their Long-Term Therapy
Effective at Maintaining Stability in Chronic Patients
n
Improved Side Effect Profile
n
No Weight Gain
Favorable Lipid Profile
Minimal Risk for Glucose Dysregulation
Lack of Hyperprolactinemia
Status NDA October 2006
* Sales for Wyeth / Solvay Alliance territories only; the United States, Canada and Mexico
Alliance with Solvay Pharmaceuticals
41
43. Methylnaltrexone Is a Selective Opioid
Antagonist
CH3
Opioids Activate Receptors
Morphine Acts Centrally and
n
in the Brain and Provide
Pain Relief… Peripherally
N
Morphine
Methylnaltrexone Is a Mu
n
Opioid Receptor Antagonist
Does Not Cross the
n
HO O OH
Blood-Brain Barrier
Antagonizes Peripheral, but
n
CH3 Not Central Opioid
Receptors
Methylnaltrexone
N+
Reverses Opioid Induced
n
Constipation Without
HO
Reversing Analgesia or
Inducing Withdrawal
… But Receptor Activation
in the GI Tract Results in
HO O O
Constipation.
43
44. Methylnaltrexone Is Active in Patients With
Opioid Induced Constipation (OIC)
> 50% of Patients Have Bowel Movement
Within 4 Hours (Study 301)
70
% Patients Having Bowel Movement
60
50
40
30
20
10
0
Placebo 0.15 mg/kg 0.30 mg/kg
Recommended Dose
44
45. Methylnaltrexone Induces a
Rapid and Predictable Response in OIC
75%
30 m inutes
0.30 mg/kg
% Patients Having
Bowel Movement
0.15 mg/kg
50%
25%
Placebo
0%
0 4
1 2 3 5
Hours
Study 301
Recommended Dose
45
46. Methylnaltrexone IV Accelerates Recovery in
Post Operative Ileus (POI) - Phase 2 Data
65 Patients With Segmental Colectomies
n
Randomized to Methylnaltrexone IV or Placebo
Evaluated for Clinical Signs Indicating Recovery of Bowel Function and
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
46
47. Methylnaltrexone: Future Standard for Rapid
and Predictable Relief of Opioid Side Effects
Novel Approach to Control of Opioid Side Effects
n
Relieves Constipation and Allows Maintenance of Pain Control
Phase 3 (SC) Data Show Positive Results in Patients
n
With Advanced Illness Whose Palliative Care Includes
Opioids
Phase 2 (IV) Studies - Positive Results for Post
n
Surgical Recovery of Bowel Function
Drug Was Generally Well Tolerated
n
47
48. Methylnaltrexone Product Profile
First Multi-Formulation Treatment
for Peripheral Opioid Side Effects
SC – NDA Early 2007 (1st for OIC)
Status IV – Phase 3: File Late 2007 or Early 2008 (1st /Only IV)
Oral – Phase 2: File Late 2008 or Early 2009 (OIC)
Development Collaboration With Progenics
48
49. Late Stage Pipeline: The Next Wave of Launches
NDA’s Filed or Expected to File in 2007
Lybrel Contraception
Lybrel Contraception
2005
Pristiq Major Depressive Disorder
Pristiq Major Depressive Disorder
Pristiq Vasomotor Symptoms
Pristiq Vasomotor Symptoms
Viviant Osteoporosis Prevention
Viviant Osteoporosis Prevention
2006
Torisel Renal Cell Cancer
Torisel Renal Cell Cancer
Bifeprunox Schizophrenia
Bifeprunox Schizophrenia
Viviant Osteoporosis Treatment
Viviant Osteoporosis Treatment
Aprela Menopausal Symptoms/Osteoporosis
Aprela Menopausal Symptoms/Osteoporosis
2007 Torisel Mantle Cell Lymphoma
Torisel Mantle Cell Lymphoma
Methylnaltrexone SC – Opioid Induced Constipation
Methylnaltrexone SC – Opioid Induced Constipation
IV – Post Operative Ileus
IV – Post Operative Ileus
Tygacil* CAP/HAP
Tygacil* CAP/HAP
* Tygacil already approved, not a new drug
49
50. J.P. Morgan 25th Annual
Healthcare Conference
Joseph S. Camardo, M.D.
Senior Vice President Global Medical
Affairs and North American Medical
Director, Wyeth Pharmaceuticals
January 9, 2007
