wyeth jpmorgan 25th annual healthcare conference
TRANSCRIPT
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
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.
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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
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
1313--ValentValent PneumococcalPneumococcalPolysaccharide Conjugate Polysaccharide Conjugate Vaccine (13v Vaccine (13v PnCPnC))
Infants and Adults
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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
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
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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
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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
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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
PristiqPristiq™™ (DVS(DVS--233)233)(Desvenlafaxine Succinate)(Desvenlafaxine Succinate)
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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
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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
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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
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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%)*
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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)
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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
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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
ViviantViviant™™/Aprela/Aprela™™
(Bazedoxifene) and (Bazedoxifene) and (Bazedoxifene/Conjugated(Bazedoxifene/ConjugatedEstrogens)Estrogens)
Alliance with Ligand Pharmaceuticals
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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
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-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
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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
™
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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
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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
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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
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
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
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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
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
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Aprela™ and Viviant™
Comprehensive Menopausal Therapy
Aprela(Bazedoxifene/CE )
Viviant(Bazedoxifene)
Vasomotor Symptoms
Vulvovaginal Atrophy
Osteoporosis Prevention
Osteoporosis Prevention
Osteoporosis Treatment
TSEC SERM
ToriselTorisel™™
(Temsirolimus)(Temsirolimus)
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
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
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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
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
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
BifeprunoxBifeprunox
Alliance with Solvay in theUnited States, Canada and Mexico
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
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
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
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* 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
MethylnaltrexoneMethylnaltrexone
Alliance with Progenics
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
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
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
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
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
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
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
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