50
Joseph S. Camardo, M.D. Senior Vice President Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals J.P. Morgan 25 J.P. Morgan 25 th th Annual Annual Healthcare Conference Healthcare Conference January 9, 2007 January 9, 2007

wyeth JPMorgan 25th Annual Healthcare Conference

Embed Size (px)

Citation preview

Page 1: wyeth JPMorgan 25th Annual Healthcare Conference

Joseph S. Camardo, M.D.Senior Vice President Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals

J.P. Morgan 25J.P. Morgan 25thth AnnualAnnualHealthcare ConferenceHealthcare Conference

January 9, 2007January 9, 2007

Page 2: wyeth JPMorgan 25th Annual Healthcare Conference

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, risksassociated 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 andobtaining 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.

Page 3: wyeth JPMorgan 25th Annual Healthcare Conference

3

Pristiq™ Major Depressive DisorderVasomotor Symptoms

Pristiq™ Major Depressive DisorderVasomotor Symptoms

7 New Drugs - 11 Important Indications(October 5, 2006 Analyst Meeting)

Viviant™ Prevention/Treatment OsteoporosisViviant™ Prevention/Treatment Osteoporosis

Aprela™ Menopausal Symptoms/OsteoporosisAprela™ Menopausal Symptoms/Osteoporosis

Lybrel™ ContraceptionLybrel™ Contraception

Torisel™ Renal Cell CancerMantle Cell Lymphoma

Torisel™ Renal Cell CancerMantle Cell Lymphoma

Bifeprunox SchizophreniaBifeprunox Schizophrenia

Methylnaltrexone SC – Opioid Induced ConstipationIV – Post Operative Ileus

Methylnaltrexone SC – Opioid Induced ConstipationIV – Post Operative Ileus

Tygacil®* CAP/HAPTygacil®* CAP/HAP

* Tygacil already approved, not a new drug

Today’sTalk

Page 4: wyeth JPMorgan 25th Annual Healthcare Conference

PLA-695SAM-315SAM-531TTI-237PAI-749PAZ-417MST-997LXR-623SLV-313SLV-314PSI-697GSI-953AGG-523HIV Vaccine (4)MnB(2)ACC-001Inotuzumab

(CMC-544)IMA-638

HCV-796LecozotanPrinaberelMethylnaltrexone

(PO)PPM-204Bosutinib

(SKI-606)Vabicaserin(SCA-136)

HKI-27213vPnC AdultEnbrel – AsthmaBapineuzumabGAP-486MYO-029TRU-015 (RA)BMP-2 Inject.

Lybrel™ContinuousContraception

Pristiq™ (MDD)Viviant™ (Osteo)Pristiq™(VMS)Torisel (Renal)Bifeprunox

(Schizophrenia)Protonix® Ad.

GranulesBeneFIX Reform.Mylotarg-AML (EU)

Small MoleculesVaccinesProteins

Aprela™Torisel™ MCLTygacil®(HAP/CAP)Bifeprunox (Bipolar)Pristiq™

FibromyalgiaPristiq™

(Neuropathic Pain)Methylnaltrexone

(SC)Methylnaltrexone

(IV)Lybrel™ PMDDProtonix® Oral PedRapamune® Liver13vPnC InfantReFacto® AF

Phase 0 Phase 1 Phase 2 Phase 3 Registration

Phase 016

Phase 122

Phase 215

Phase 315

Registration7

27330 -9550

Wyeth Development Pipeline: Robust and Deep

SCA-171SKS-927NRI-193PPM-201PPM-202SRA-444GAP-134BLI-489SAM-610SKI-015PRA-027FXR-450ILS-920BHS-019HIV-001CME-548AAB-002ILV-094TRU-015 (Onc)

12/21/06

Page 5: wyeth JPMorgan 25th Annual Healthcare Conference

1313--ValentValent PneumococcalPneumococcalPolysaccharide Conjugate Polysaccharide Conjugate Vaccine (13v Vaccine (13v PnCPnC))

Infants and Adults

Page 6: wyeth JPMorgan 25th Annual Healthcare Conference

6

Increasing Impact of Prevnar® in U.S.

MMWR. 2005;Vol: 54(No. 36):893-897.

0

10

20

30

40

50

60

70

80

90

Average for1998 and 1999

2003

Esti

ma

ted

Ca

se

s/1

00

,00

0

Prelicensure

(1998-1999)

Postlicensure

(2003)

94%Reduction

…in Children … and Adults

0

5

10

15

20

25

30

35

Ave

rag

e I

ncid

en

ce

of

Va

ccin

e S

ero

typ

e

IPD

pe

r 1

00

,00

0 P

op

ula

tio

n

Prelicensure

(1998-1999)

Postlicensure

(2002-2003)

55%Reduction

(>50 Years of Age)

Average for

1998 and 1999

2003

Page 7: wyeth JPMorgan 25th Annual Healthcare Conference

7

The Infant Vaccine Phase 3 ProgramPrevnar 13

n Objectives:

Demonstrate the Immunological Non-Inferiority of 13v PnC to 7-valentPrevnar® in Young Infants

Demonstrate That 13v PnC Does Not Interfere With Immune Responses Elicited by Concomitantly Administered Childhood Vaccines

Demonstrate Immunological Consistency Across Multiple ProductionBatches of the Vaccine

Demonstrate the Vaccine’s Safety and Tolerability

n The Program Will Involve Approximately 4,000 Children

Page 8: wyeth JPMorgan 25th Annual Healthcare Conference

8

n Phase 2 Proof of Concept Achieved

n Licensing Criteria Agreed Upon

n Worldwide Phase 3 StudiesOngoing

n Submission – Early 2009

Status

The Most Complete Vaccine Available for the Global Prevention of Pneumococcal Diseaseand Otitis Media

13v PnC Infant Product Profile

Page 9: wyeth JPMorgan 25th Annual Healthcare Conference

9

The Adult Vaccine Phase 3 ProgramPrevnar 13

n Five Key Objectives:Demonstrate robust Immunological responses for 13v PnC in adults >50 Years of Age

Demonstrate That 13v PnC Can Enhance the Anti-PolysaccharideResponses 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

n The Program Will Involve Approximately 3,200 Adults

Page 10: wyeth JPMorgan 25th Annual Healthcare Conference

10

n Proof of Concept Achieved

n Licensing Criteria Being Finalized

n Worldwide Phase 3 ClinicalStudies to Begin in Early 2007

n Submission 2009

Status

13v PnC Adult Product Profile

The Vaccine of Choice for Adults 50 Yearsof Age and Older for the Prevention of Pneumococcal Disease

Page 11: wyeth JPMorgan 25th Annual Healthcare Conference

PristiqPristiq™™ (DVS(DVS--233)233)(Desvenlafaxine Succinate)(Desvenlafaxine Succinate)

Page 12: wyeth JPMorgan 25th Annual Healthcare Conference

12

PristiqPristiq

Pristiq™: A Single Product With Two Indications

First Line Treatment ofMajor Depressive Disorder

Associated With Menopause

Depression

First FDA-ApprovedNon-Hormonal Treatment of

Moderate-to-Severe VMS

Vasomotor Symptoms

Positioning Positioning

Page 13: wyeth JPMorgan 25th Annual Healthcare Conference

13

Pristiq™/Effexor XR®

Comparable MDD Efficacy

DVS 309-EU and 317-US: Pooled Analysis Ham-D17 Total Score (Mixed Effect Model, ITT)

-16

-14

-12

-10

-8

-6

-4

-2

0

1 2 3 4 5 6 7 8Week

Ch

an

ge

fro

m B

ase

lin

e

Ha

m-D

17 T

ota

l

* *

**

* *

*

*

*

**

Placebo

Effexor XR75-150 mg

Effexor XR150-225 mg

Pristiq 200-400 mg

* P < 0.05 vs placebo

Pooled Post-Hoc Analysis

Page 14: wyeth JPMorgan 25th Annual Healthcare Conference

14

Pristiq™: Effective in ReducingNumber of Moderate and Severe VMS

100 mg dose: p-value versus placebo < 0.05 at all time points150 mg dose: p-value versus placebo < 0.05 at all time points

2

3

4

5

6

7

8

9

10

11

12

13

0 1 2 3 4 5 6 7 8 9 10 11 12

Weeks

# o

f F

lush

es

2

3

4

5

6

7

8

9

10

11

12

13

0 1 2 3 4 5 6 7 8 9 10 11 12

Weeks

# o

f F

lush

es

Study 315 Study 319

Pristiq100 mg

Pristiq150 mg

Placebo

Pristiq 150 mg

Pristiq 100 mg

Placebo

Page 15: wyeth JPMorgan 25th Annual Healthcare Conference

15

Pristiq™: Safety and Tolerability Profile

Nervousness

Somnolence

Tremor

Sweating

Abnormal Vision

Mydriasis

Abnormal Ejaculation/Orgasm

Impotence (Male)

Asthenia

Hypertension

Anorexia

Constipation

Dry Mouth

Nausea

Vomiting

Dizziness

Insomnia

*Most common adverse drug reactions (>5%), pooled data VMS+MDD

Consistent With the SNRI Class

(Adverse Reactions ≥ 5%)*

Page 16: wyeth JPMorgan 25th Annual Healthcare Conference

16

Pristiq™ Low-Dose Program

MDD

n 3 Ongoing Low-Dose Studies 50, 100 mg, Placebo (2 Studies U.S., EU)

50, 100 mg, Placebo, Duloxetine

n 1 Low-Dose Study to Support Registration in Asia

n Additional Low-Dose Drug-Drug Interaction Studies Underway

VMS

n Titration Study – 25, 50, 100 mg (Ongoing)

Page 17: wyeth JPMorgan 25th Annual Healthcare Conference

17

Pristiq™ Will Broaden the Reach of Our SNRI Franchise

Green = Effexor XR®

Blue = Pristiq™

Red = Effexor/PristiqPanic

DisorderPanic

Disorder

SocialAnxietyDisorder

SocialAnxietyDisorder

GeneralizedAnxietyDisorder

GeneralizedAnxietyDisorder

VasomotorSymptoms ofMenopause

VasomotorSymptoms ofMenopause

FibromyalgiaSyndrome

FibromyalgiaSyndrome

MajorDepressive

Disorder

MajorDepressive

Disorder

Page 18: wyeth JPMorgan 25th Annual Healthcare Conference

18

MDD NDA Dec 2005

VMS NDA June 2006Status

Pristiq™ Product Profile for Major Depression or VMS

Can Become the First and Only SNRI Proven to Effectively Address the DistinctiveSymptoms and Therapeutic Needs of Women With Depression Associated With Menopause or Vasomotor Symptoms

Page 19: wyeth JPMorgan 25th Annual Healthcare Conference

ViviantViviant™™/Aprela/Aprela™™

(Bazedoxifene) and (Bazedoxifene) and (Bazedoxifene/Conjugated(Bazedoxifene/ConjugatedEstrogens)Estrogens)

Alliance with Ligand Pharmaceuticals

Page 20: wyeth JPMorgan 25th Annual Healthcare Conference

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

To Be the First New SERM in Nearly 10 Years Providing Physicians a New Option for Patients at Risk of Osteoporosis and Fracture

Page 21: wyeth JPMorgan 25th Annual Healthcare Conference

21

-2.00

-1.00

0.00

1.00

Baseline Month 6 Month 12 Month 18 Month 24

Ad

juste

d P

erc

en

t C

ha

ng

e

Viviant™ Prevents Osteoporosis

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

Viviant 10 mg

Viviant 20 mg

Viviant 40 mgRaloxifene 60 mg

Placebo

Lumbar Spine BMDPhase 3 Study

Page 22: wyeth JPMorgan 25th Annual Healthcare Conference

22

Viviant™: Analysis of Endometrial Effects

0

1

2

3

4

5

Placebo Viviant 10 Viviant 20 Viviant 40 Raloxifene 60

* Statistically significant to RLX and PCB

**

% P

atie

nts

Wit

h E

nd

om

etri

al T

reat

men

t E

mer

gen

t A

dve

rse

Eve

nts

Includes Clinically Significant Endometrial Thickness, Hyperplasia, Polyp, and Carcinoma

Page 23: wyeth JPMorgan 25th Annual Healthcare Conference

23

Viviant Clinical Profile

n Achieved Osteoporosis Prevention As Measuredby BMD

n Good Endometrial Safety ProfileNo Increase in Hyperplasia, Polyps, or Thickness

n Side Effect Profile: Increase From PlaceboHot Flush Venous Thrombosis Leg Cramps

n Less Breast Tenderness Versus Placebo

Page 24: wyeth JPMorgan 25th Annual Healthcare Conference

24

Target

The Most Comprehensive Medicinefor Menopause

The Most Comprehensive Medicinefor Menopause

Aprela™: Optimal Targeted Response ofTissue Selective Estrogens Complex (TSEC)

TSEC

Increased Bone Mass

Vaginal Health

Improved Hot Flush

Prevent Endometrial Hyperplasia

Decreased Breast Tenderness

Page 25: wyeth JPMorgan 25th Annual Healthcare Conference

25

Aprela™ Prevents Osteoporosis

p vs PBO ≤ 0.001 (all BZA/CE groups at 6, 12, 18 and 24m)* p vs RAL < 0.05

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0.5

1.0

1.5

2.0

Ad

juste

d M

ea

n %

Ch

an

ge

*

*

*

*

**

**

Baseline Month 6 Month 12 Month 18 Month 24

Placebo

Aprela 20/0.625

Aprela 20/0.45

Raloxifene

Lumbar Spine BMDPhase 3 Study

BMD Change Relative to Placebo:20/0.625: ↑ 3.72% at 2y20/0.45: ↑ 3.61% at 2y

Page 26: wyeth JPMorgan 25th Annual Healthcare Conference

26

-10

-8

-6

-4

-2

0

0 1 2 3 4 5 6 7 8 9 10 11 12

Week

Ad

jus

ted

Me

an

Ch

an

ge

Fro

m B

as

eli

ne

Number of Moderate-to-Severe Symptoms

Aprela™ Effectively Treats Vasomotor Symptoms

Statistically significant at all end points vs placebo and 8 – 12 weeks vs raloxifeneData on file: Ph 3 BZA/CE analysis 3115A1-303 study

Phase 3 Study

Placebo

Aprela 20/0.625

Aprela 20/0.45

Raloxifene

Page 27: wyeth JPMorgan 25th Annual Healthcare Conference

27

Aprela™ Bleeding Profile - No Breakthrough Bleeding

Aprela™ 20/0.625Aprela 20/0.45

Placebo

CE/MPA 0.45/1.5CE/MPA 0.625/2.5

0%

20%

40%

60%

80%

100%

1 2 3 4 5 6 7 8 9 10 11 12 13

Comparison to Prempro™ by Historical Data

Months

% Subjects With Amenorrhea Over 1 Year

Data on file: Ph 3 BZA/CE analysis 3115A1-303 study

Page 28: wyeth JPMorgan 25th Annual Healthcare Conference

28

Aprela™ Provided Excellent Endometrial and Breast Safety/Tolerability - Phase 3

n After 2 Years of Treatment With AprelaEndometrium

- 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

Page 29: wyeth JPMorgan 25th Annual Healthcare Conference

29

Aprela - The First TSECA New Class for Menopausal Treatment

n Product ProfileRelieves Vasomotor Symptoms

Prevents Osteoporosis

Improves Vulvovaginal Atrophy (VVA)

Excellent Amenorrhea

Less Breast Tenderness

Provides Endometrial Protection Without Progestin

n NDA Filing: Late 2007

Most Significant Medical Advancein Menopausal Therapy

Most Significant Medical Advancein Menopausal Therapy

Page 30: wyeth JPMorgan 25th Annual Healthcare Conference

30

Aprela™ and Viviant™

Comprehensive Menopausal Therapy

Aprela(Bazedoxifene/CE )

Viviant(Bazedoxifene)

Vasomotor Symptoms

Vulvovaginal Atrophy

Osteoporosis Prevention

Osteoporosis Prevention

Osteoporosis Treatment

TSEC SERM

Page 31: wyeth JPMorgan 25th Annual Healthcare Conference

ToriselTorisel™™

(Temsirolimus)(Temsirolimus)

Page 32: wyeth JPMorgan 25th Annual Healthcare Conference

32

0.0078

49%

10.9 mo

143209

ToriselTorisel

210207Patients

0.6965Log Rank p-ValueStratified

8.4 mo7.3 moMedian Overall Survival

15%

152

InterferonInterferon+ Torisel+ Torisel

149

InterferonInterferon

% Improvement in Survival

# Deaths

Based on Data for Wyeth NDA

Torisel™ Is the First New Drug Shown to Significantly Improve Survival in RCC

Page 33: wyeth JPMorgan 25th Annual Healthcare Conference

33

Overall Survival Extended by More Than 3 Months With Torisel™

0.00

0.25

0.50

0.75

1.00

0 5 10 15 20 25 30

Time to Death (Months)

Su

rviv

al D

istr

ibu

tio

n

Fu

ncti

on

Torisel

IFN

10.9 mo7.3 mo

FromARCC Study

Page 34: wyeth JPMorgan 25th Annual Healthcare Conference

34

Patients on Torisel™ Live Longer and Maintain Quality of Life

0

2

4

6

8

10

TWiST

Mo

nth

s

Interferon

Torisel

* Torisel significantly better, p=.0005

*

Q-TWiST

Interferon

Torisel*

Torisel Extends Time Without Symptoms of Progression or Toxicity

Page 35: wyeth JPMorgan 25th Annual Healthcare Conference

35

InterferonPlaceboInterferonComparator

1st Line Good/ Intermediate Prognosis

N=750

Sutent

2nd Line Good/ Intermediate Prognosis

N = 769 Patients

Nexavar(Current Indication)

1st Line Poor/ Intermediate Prognosis

N = 626 Patients

StudyPopulation

Torisel

Torisel™ Is Unique Among the New RCC Drugs

120% Improvement

11 vs. 5 Months

99% Improvement

5.9 vs. 2.8 Months

77% Improvement

5.5 vs. 3.1 Months

Progression-free Survival

Survival No Significant Improvement

No Significant Improvement

49% Improvement10.9 vs. 7.3 Months

Page 36: wyeth JPMorgan 25th Annual Healthcare Conference

36

n Torisel Alone Improves Overall Survival (49%) in 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

n Torisel Also Preserves Patients’ Quality of Life

Torisel™ Is a Unique and EffectiveNew Treatment for Renal Cell Cancer

Only Agent to Show an RCC Survival Benefit

Positions Torisel to Be RCC Drug of ChoicePositions Torisel to Be RCC Drug of Choice

Page 37: wyeth JPMorgan 25th Annual Healthcare Conference

BifeprunoxBifeprunox

Alliance with Solvay in theUnited States, Canada and Mexico

Page 38: wyeth JPMorgan 25th Annual Healthcare Conference

38

BifeprunoxBifeprunox Patients Remained RelapsePatients Remained Relapse--Free Longer Free Longer Than Placebo Patients Over 6 MonthsThan Placebo Patients Over 6 Months

Bifeprunox: Study 10214 Efficacy

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

0 30 60 90 120 150 180

Time in Days

Ka

pla

n-M

eie

r E

sti

ma

tes

p-Value = 0.008

Bifeprunox 20 mg

Bifeprunox 30 mg

Placebo

Page 39: wyeth JPMorgan 25th Annual Healthcare Conference

39

Bifeprunox: Study 10214 Safety

* p < 0.05 bifeprunox versus placebo

-5

-4

-3

-2

-1

0

Placebo Bifeprunox 20 mg Bifeprunox 30 mg

*

We

igh

t C

ha

ng

e F

rom

Ba

se

lin

e (

Lb

s) Mean Weight Change

BifeprunoxBifeprunox Patients Lost Weight on Average Patients Lost Weight on Average After 6 MonthsAfter 6 Months

Page 40: wyeth JPMorgan 25th Annual Healthcare Conference

40

Bifeprunox: Study 10214 Safety

0%

10%

20%

30%

40%

50%

Placebo Bifeprunox 20 mg Bifeprunox 30 mg

Definition of assessable: 4 or more MS criteria have been measuredMS present: 3 or more MS criteria are fulfilled

% Patients with Metabolic Syndrome

Baseline

End ofStudy

Baseline End ofStudy

BaselineEnd ofStudy

BifeprunoxBifeprunox Did Not Cause Metabolic SyndromeDid Not Cause Metabolic Syndrome

Page 41: wyeth JPMorgan 25th Annual Healthcare Conference

41

* Sales for Wyeth / Solvay Alliance territories only; the United States, Canada and Mexico

Alliance with Solvay Pharmaceuticals

Bifeprunox Safely Maintains Stability in Schizophrenia

n Relief for Patients Where Metabolic Changes Have Challenged Their Long-Term Therapy

n Effective at Maintaining Stability in Chronic Patients

n Improved Side Effect ProfileNo Weight Gain

Favorable Lipid Profile

Minimal Risk for Glucose Dysregulation

Lack of Hyperprolactinemia

NDA October 2006Status

Page 42: wyeth JPMorgan 25th Annual Healthcare Conference

MethylnaltrexoneMethylnaltrexone

Alliance with Progenics

Page 43: wyeth JPMorgan 25th Annual Healthcare Conference

43

HO O

N

OH

CH3

Morphine

Methylnaltrexone

HO O

N+

HO

O

CH3

n Morphine Acts Centrally and Peripherally

n Methylnaltrexone Is a MuOpioid Receptor Antagonist

n Does Not Cross theBlood-Brain Barrier

n Antagonizes Peripheral, but Not Central OpioidReceptors

n Reverses Opioid Induced Constipation Without Reversing Analgesia or Inducing Withdrawal

Opioids Activate Receptorsin the Brain and ProvidePain Relief…

… But Receptor Activationin the GI Tract Results inConstipation.

Methylnaltrexone Is a Selective Opioid Antagonist

Page 44: wyeth JPMorgan 25th Annual Healthcare Conference

44

0

10

20

30

40

50

60

70

Placebo 0.15 mg/kg 0.30 mg/kg

% P

ati

en

ts H

avin

g B

ow

el

Mo

ve

me

nt

Methylnaltrexone Is Active in Patients With Opioid Induced Constipation (OIC)

> 50% of Patients Have Bowel MovementWithin 4 Hours (Study 301)

Recommended Dose

Page 45: wyeth JPMorgan 25th Annual Healthcare Conference

45

Methylnaltrexone Induces aRapid and Predictable Response in OIC

Recommended Dose

% P

ati

en

ts H

avin

g

Bo

we

l M

ove

me

nt

Hours

0%

25%

50%

75%

0 1 2 3 4 5

0.30 mg/kg30 minutes

0.15 mg/kg

Placebo

Study 301

Page 46: wyeth JPMorgan 25th Annual Healthcare Conference

46

23 HoursFirst Bowel Movement (P=0.01)

25 HoursTolerance of First Solid Meal (P=0.12)

AccelerationAcceleration(On Average)(On Average)Time to PostTime to Post--Operative Recovery EndpointOperative Recovery Endpoint

n 65 Patients With Segmental ColectomiesRandomized to Methylnaltrexone IV or Placebo

Evaluated for Clinical Signs Indicating Recovery of Bowel Function and Readiness for Discharge

Methylnaltrexone IV Accelerates Recovery in Post Operative Ileus (POI) - Phase 2 Data

25 HoursActual Discharge (P=0.09)

30 HoursDischarge Eligibility (P=0.03)

Discharge a Day EarlyDischarge a Day Early

Page 47: wyeth JPMorgan 25th Annual Healthcare Conference

47

Methylnaltrexone: Future Standard for Rapid and Predictable Relief of Opioid Side Effects

n Novel Approach to Control of Opioid Side EffectsRelieves Constipation and Allows Maintenance of Pain Control

n Phase 3 (SC) Data Show Positive Results in Patients With Advanced Illness Whose Palliative Care IncludesOpioids

n Phase 2 (IV) Studies - Positive Results for Post Surgical Recovery of Bowel Function

n Drug Was Generally Well Tolerated

Page 48: wyeth JPMorgan 25th Annual Healthcare Conference

48

SC – NDA Early 2007 (1st for OIC)

IV – Phase 3: File Late 2007 or Early 2008 (1st /Only IV)

Oral – Phase 2: File Late 2008 or Early 2009 (OIC)

Status

Development Collaboration With Progenics

Methylnaltrexone Product Profile

First Multi-Formulation Treatmentfor Peripheral Opioid Side Effects

Page 49: wyeth JPMorgan 25th Annual Healthcare Conference

49

Late Stage Pipeline: The Next Wave of Launches NDA’s Filed or Expected to File in 2007

Viviant Osteoporosis TreatmentAprela Menopausal Symptoms/OsteoporosisTorisel Mantle Cell LymphomaMethylnaltrexone SC – Opioid Induced Constipation

IV – Post Operative IleusTygacil* CAP/HAP

Viviant Osteoporosis TreatmentAprela Menopausal Symptoms/OsteoporosisTorisel Mantle Cell LymphomaMethylnaltrexone SC – Opioid Induced Constipation

IV – Post Operative IleusTygacil* CAP/HAP

Lybrel ContraceptionPristiq Major Depressive Disorder

Lybrel ContraceptionPristiq Major Depressive Disorder

* Tygacil already approved, not a new drug

Pristiq Vasomotor SymptomsViviant Osteoporosis PreventionTorisel Renal Cell CancerBifeprunox Schizophrenia

Pristiq Vasomotor SymptomsViviant Osteoporosis PreventionTorisel Renal Cell CancerBifeprunox Schizophrenia

2005

2006

2007

Page 50: wyeth JPMorgan 25th Annual Healthcare Conference

Joseph S. Camardo, M.D.Senior Vice President Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals

J.P. Morgan 25J.P. Morgan 25thth AnnualAnnualHealthcare ConferenceHealthcare Conference

January 9, 2007January 9, 2007