r&d day show am v3
TRANSCRIPT
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GROWTH PHARMA
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SAUNDERSBRENT
Chief Executive Officer and President
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Customer Intimacy is Critical
CUSTOMER
Private
Companies VentureCapital
Regional
Players
PrivateEquity
Start-Ups
IDEAS
PATIENTS
DevelopmentPowerhouse
CommercialMachine
BusinessDevelopment
TherapeuticArea
Leader
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SOURCE: Evaluate1 Excludes generics; Botox sales allocated by TA/Indication into Dermatology & Aesthetics, CNS, and Urology
2015 revenue1
Customer Intimacy & Therapeutic Area LeadershipDrive Commercial Success
Top Brands
global positionDermatology &
Aesthetics $2.1
global positionEye Care $3.0
in Alzheimers
#3 global positionCNS
$2.7
global position
#2 in anti-inflammatoriesGI $1.2
in US
Plan to double presence by 2020Womens Health $1.0
global positionUrology $0.4
Anti-infectiveUS leadership position
2 new breakthrough product launches$0.2
Sales ($B)
1
2
1
3
1
6
1
Ranking
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SOURCE: Thomson Reuters, PitchBook database
A New Pharmaceutical Innovation EcosystemFueled by Significant Investments
500
1,000
1,500
2,000
2,500
3,000
3,500
0
0.51.1
1.6
2.2
2.7
3.3
3.8
4.34.9
5.4
6.0
6.5
Venturecapitalinvested,
$B
Numberofbiotech
startups
20102000 20051995 2014
Sustainability: Continued
VC funding
Scientificcreativity
Professionalmanagement
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Revenues of all NME-grade compounds launched in a given year cumulated for 7-8 years. Includes all innovative compounds classified as NME or BLA, excludinggenerics, biosimilars and NDA products (new derivatives, new formulations etc.)SOURCE: Evaluate 2014
Pharma Innovation EcosystemSource of NMEs by originator type
14%Biotech & Start-upCompanies
24%Regional PharmaNon-profit AcademiaSpecialty
ACADEMIA
SPECIALTY
GLOBALPHARMA
BIOTECH &START-UPS
REGIONALPHARMA62%
Global Pharma
1998
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22%Global Pharma
Evaluate Jul 20 Revenues of all NME-grade compounds launched in a given year cumulated for 7-8 years. Includes all innovative compounds classified as NME orBLA, excluding generics, biosimilars and NDA products (new derivatives, new formulations etc.)SOURCE: Evaluate 2014 14; McKinsey analysis
Pharma Innovation Ecosystem
50%Biotech & Start-upCompanies
ACADEMIA
SPECIALTY
GLOBALPHARMA
BIOTECH &
START-UPS
REGIONALPHARMA
28%Regional PharmaNon-profit AcademiaSpecialty
Source of NMEs by originator type
2013
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New
ACADEMIA
GLOBALPHARMA
BIOTECH &START-UPS
REGIONALPHARMA
SPECIALTY
Pharma Innovation Ecosystem
TODAY
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We discover, acquire, partner and collaborate on compounds at all stages of R&D with a strong preference for validated targets or compounds with proof of concept.
Allergan ModelDISCOVERY DEVELOPMENT COMMERCIALIZATION
CGRPs
Ozurdex
Latisse
Avycaz
Linzess
Kybella
XEN45
Bimatoprost SR
Restasis X
Abicipar
RelamoralinKYTH-105
JuvedermBotox
AGN-241660
Rapastinel
SER 120
Esmya
NebivololVraylarBystolic/Valsartan
Viberzi
Dalvance
OD-01
CUSTOMER
Teflaro
Combigan
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SOURCE: Evaluate; Capital IQ1 Based on 2014 R&D spend/revenue and % of clinical non-generic NME, NDA, and biologic pipeline assets that are non-organic
Allergan is a Forerunner in
Low High
% pipeline externally sourced1
Low
High
R&D/
Sales1
Open science
Low-cost
Traditional
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SOURCE: Evaluate; FDA; Press search1 Includes new fixed-dose combinations and co-developments2 NDA/NME approval time for assets with projected 2020 sales in Allergan-relevant TAs
Allergan Ranks Among the Top Development
PowerhousesNumber of NME/BLAapprovals 2009-2015 YTD
Average time between submissionof drug and approval (months)2
113
16
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SOURCE: Evaluate1 Aesthetics & Derm, Eye Care, Urology, GI, Anti-infectives, CNS
is Sustainable:Approximately Half of All Phase 2 & Phase 3 Programs Are in Allergan TAs
Phase 2
1,026
Gastro-Intestinal
827
Respiratory
Phase 3
Oncology &Immunomodulators
Phase 1
Blood/CV/Endocrine
Central Nervous System
Systemic Anti-infectives
Urology/Derm/Eye
571
Allergan relevant TAs
Other TAs33%
45%49%
TA pipeline assets in each clinical phase (%); total of ~2400 assets
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SOURCE: McKinsey survey
We have the profile for partnering a key to open science
We Have the Profile for Partnering
A Key to
Expected
Execution
Speed
ExecutiveLeadership
Manufacturing
SharedVision
PriorRelationship
Legal
Research
DevelopmentPowerhouse
CommercialEngine
OpenMindset
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21
Aesthetics &Dermatology
OxymetazolineRosacea
Aczone ReformAcne Vulgaris
Sarecycline
Acne
JuvedermGlobal NasalLabial Folds
VobellaLips Fine Lines
BotoxForeheadLines
VoliftNasolabial Folds
VolumaFiller for Temple
Voluma PlusFacial Volumes
Voluma GlobalMalar Augmentation
PhoenixBreast Augmentation
VoLiteFiller
VolumaFiller for Chin
OxybutyninHyperhidrosis
BimatoprostAndrogenic
Alopecia
MT10109LAesthetics
Facial Lines
HA ThreadsForehead & Neck
Skin Quattro DeviceDelivery for
Facial Fillers
Aczone ComboAcne Vulgaris
SetipiprantAndrogenic Alopecia
BimatoprostSubmental Fat Reduct 17
EyeCare
Tripligan(MMT) Ocular HTN & Glaucoma
FPR2Agonist Dry Eye Disease
MimetogenDry Eye
Bimatoprost SRGlaucoma
GanfortMDPF
RestasisMDPF
Omega 3 OTCDry Eye
Pilo/OxyPresbyopia
Cortisol AnalogDry Eye Disease
Brimo DDSAtrophic AMD
AndrogenEvaporative Dry Eye
Cyclosporine SRDry Eye
DARPinDME
Dual DARPinAMD
DARPinSRAMD
OCU Tearbud 1Dry Eye
Women s Health
4 EstradiolVaginal Cream VVA& Dyspareunia
UlipristalFibroids
EstradiolVag Caps VVA
& Dyspareunia
Etonogestral RingContraception
GI
LinzessOIC
LinzessColonic
Release CIC
LinzessLow Dose CIC
ViberziIBS-D
9CNS
RapastinelMDD
AGN-241689Migraine
Prophylaxis
UbrogepantAcuteMigraine
BotoxMDD
Vraylar Multiple
SempranaAcute Migraine
Vraylar Bipolar Depression
Botox X
Spasticity
AGN-241660MDD
9
Biosimilar XIndication X
AvycazcUTI, cIAI
5
Anti-Infective
DalbavancinOsteomyelitis
DalbavancinEndocarditis
Dalbavancin ABSSSISingle Dose
Nebivilol/ValsartanHypertension
BotoxMultiple
BevacizumabMultipleCancer
CetuximabMultiple
Cancer
TrastuzumabMultipleCancer
RituximabNon-Hodgkin
Lymphoma
TRV-027Acute Heart Failure
Armour ThyroidHypothyroidism
Other(Biosimilars, Cardiovascular
and other)
5
Urology
4BotoxPremature
Ejaculation
LiRISInterstitial
Cystitis
SER-120Adult Nocturia
BotoxIndication X
DARPinAMD
RelamorelinDiabetic
GastroparesisAztreonam /AvibactamGram Neg Infect
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DAVIDNICHOLSON
Executive Vice President,Brand R&D
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21
Aesthetics &Dermatology
OxymetazolineRosacea
Aczone ReformAcne Vulgaris
Sarecycline
Acne
JuvedermGlobal NasalLabial Folds
VobellaLips Fine Lines
BotoxForeheadLines
VoliftNasolabial Folds
VolumaFiller for Temple
Voluma PlusFacial Volumes
Voluma GlobalMalar Augmentation
PhoenixBreast Augmentation
VoLiteFiller
VolumaFiller for Chin
OxybutyninHyperhidrosis
BimatoprostAndrogenic
Alopecia
MT10109LAesthetics
Facial Lines
HA ThreadsForehead & Neck
Skin Quattro DeviceDelivery for
Facial Fillers
Aczone ComboAcne Vulgaris
SetipiprantAndrogenic Alopecia
BimatoprostSubmental Fat Reduct 17
EyeCare
Tripligan(MMT) Ocular HTN & Glaucoma
FPR2Agonist Dry Eye Disease
MimetogenDry Eye
Bimatoprost SRGlaucoma
GanfortMDPF
RestasisMDPF
Omega 3 OTCDry Eye
Pilo/OxyPresbyopia
Cortisol Analog
Dry Eye Disease
Brimo DDSAtrophic AMD
AndrogenEvaporative Dry Eye
Cyclosporine SRDry Eye
DARPinDME
Dual DARPinAMD
DARPinSRAMD
OCU Tearbud 1Dry Eye
Women s Health
4 EstradiolVaginal Cream VVA& Dyspareunia
UlipristalFibroids
EstradiolVag Caps VVA
& Dyspareunia
Etonogestral RingContraception
GI
LinzessOIC
LinzessColonic
Release CIC
LinzessLow Dose CIC
ViberziIBS-D
9CNS
RapastinelMDD
AGN-241689Migraine
Prophylaxis
UbrogepantAcuteMigraine
BotoxMDD
Vraylar Multiple
SempranaAcute Migraine
Vraylar Bipolar Depression
Botox X
Spasticity
AGN-241660MDD
9
Biosimilar XIndication X
AvycazcUTI, cIAI
5
Anti-Infective
DalbavancinOsteomyelitis
DalbavancinEndocarditis
Dalbavancin ABSSSISingle Dose
Nebivilol/ValsartanHypertension
BotoxMultiple
BevacizumabMultipleCancer
CetuximabMultiple
Cancer
TrastuzumabMultipleCancer
RituximabNon-Hodgkin
Lymphoma
TRV-027Acute Heart Failure
Armour ThyroidHypothyroidism
Other(Biosimilars, Cardiovascular
and other)
5
Urology
4BotoxPremature
Ejaculation
LiRISInterstitial Cystitis
SER-120Adult Nocturia
BotoxIndication X
DARPinAMD
RelamorelinDiabetic
GastroparesisAztreonam /AvibactamGram Neg Infect
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21
Aesthetics &Dermatology
OxymetazolineRosacea
Aczone ReformAcne Vulgaris
Sarecycline
Acne
BimatoprostAndrogenic
Alopecia
SetipiprantAndrogenic Alopecia
17
EyeCare
RestasisMDPF
Pilo/OxyPresbyopia
DARPinDME
OCU Tearbud 1Dry Eye
Women s Health
4UlipristalFibroids
GIViberzi
IBS-D
9CNS
RapastinelMDD
AGN-241689Migraine
Prophylaxis
UbrogepantAcuteMigraine
Vraylar Multiple
Vraylar Bipolar Depression
AGN-241660MDD
9
AvycazcUTI, cIAI
5
Anti-Infective
Other(Biosimilars, Cardiovascular
and other)
5
Urology
4
SER-120Adult Nocturia
DARPinAMD
RelamorelinDiabetic
Gastroparesis
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9
Biosimilar XIndication X
Nebivilol/ValsartanHypertension
Botox
Multiple
Bevacizumab
Multiple Cancer
CetuximabMultiple Cancer
TrastuzumabMultiple Cancer
RituximabNon-Hodgkin Lymphoma
TRV-027 Acute Heart Failure
Armour ThyroidHypothyroidism
Other(Biosimilars, Cardiovascular and other)
PC
R
P3
P3
P2
PC
PC
PC
P2
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BILLMEURY
Executive Vice President &President, Branded Pharma
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GI
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in Action
Use Open Science Modelto Sustain Leadership
Underlying Logic behindGI Strategy
Relamorelin
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5
GI
LinzessLow Dose CIC
ViberziIBS-D
Linzess
OIC
LinzessColonic Release CIC P2
P2
P3
R
RelamorelinDiabetic Gastroparesis
P2
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Delivering and Building a Leading GI PipelineViberzi(eluxadoline):
FDA approval 5/2015
- Recommended schedule IV
- Expected launch late 2015
EU submitted expected launch 2017
Delzicol(mesalamine):sNDA 4x100mg formulation approval 9/2015
Linzess(linaclotide): low dose (72mcg) Phase 3 Topline results 10/2015
Statistically signicant improvement on the 12-week Complete SpontaneousBowel Movements (CSBM)
Rates of diarrhea and discontinuation for the 72mcg dose lower than 145mcgfor CIC
Relamorelin:Phase 2b recruitment on schedule
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Targets the core components of IBS-D, diarrhea and abdominal pain helpingprovide lasting relief
Treats IBS-D
VIBERZI Targets Opioid Receptors in the GI Tract
with low systemic bioavailability
First and only mu- and kappa-opioid receptoragonist, and delta-opioid receptor antagonist
= VIBERZISlows GImotility
Reduces
diarrhea
Reducesvisceral pain
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*p=0.05; p
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Rapid and Sustained Response
Rates Over Time
Dailycompositeresponderrate(%) 60
40
0
50
30
10
20
Placebo
Eluxadoline 75 mg
Eluxadoline 100 mg
Pooled IBS-3001 and IBS-3002 Data
7 14 21 28 35 42 49 56 63 70 77 84 91 98 105 112 119 126 133 140 147 154 161 168 175 182
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Works in Loperamide Responders
and Non-RespondersSelf-report NOT AdequateControl with Loperamide
Placebo ELX 75mg BID ELX 100mg BID
Com
positeEndpointResponseRates(%)
Self-report AdequateControl with Loperamide
Placebo ELX 75mg BID ELX 100mg BID
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Urgency and Sustained Symptom Relief
Most Important to GIs
GEs
Importance PerformanceOTC Medications
Attributes n = 41 n = 40
Provides sustained relief
of symptoms 76% 10%
Reduces urgency of diarrhea 76% 44%
Effective at relieving bothdiarrhea and pain 71% 22%
Provides effective relief
of abdominal pain 59% 15%
% of Respondent Rating Importance and Performance 6 or 7 on 1-7 scale (Top 2 Box)
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Could Achieve $1B in Sales
Allergan will have fullPCP and GI coverage
Rxs
8MM
OTC Units62MM
Key to Successful Launch:
1. Viberzi is pharmacologically differentfrom OTCs and Xifaxan
2. Clinically high response rates& low relapse rates
Convert OTC marketthrough extensive consumeradvertising and education
Allergan will achieve shareof voice leadership inprofessional and consumeradvertising
IWD
Allergan GI
Allergan PCP
1,404 Reps
~450 Reps
Allergan Competitor
$15B Market (Rx & OTC)
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PATIENT
EXPERIENCE
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Linzess is hitting on all cylinders
Two near terms product improvements to accelerateconvert OTC market
Sprinkle formulations
Low dose 72 mcg
Indication for Opioid Induced Constipation
Next generation Linzess
Colonic delivery program
Better pain relief Low side effects
Linzess: Building a Blockbuster
Source: IMS NPA as of 1/30/15 , IMS Xponent of 1/2/15 and IMS Source of Business Report, Nov 2014
DTC fueling double digit growth
DTC LTC Launch
Linzess 10 Year Projection
2015-2024
$1B+Sprinkles Form
Low Dose
Colonic Delivery
OIC
Summary
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RELAMORELIN
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Diabetic Gastroparesis is a Chronic Disease
with
No Adequate TreatmentLimited Treatment Options Available
Current options (metoclopramide, domperidone) have a boxed warning or are notapproved worldwide. They are associated with side-effects and limit on Rx duration
Existing therapies lack durable long term efcacy
No newgastroparesis therapy approved in US in over 30 years
a
b
c
Relamorelin is a Potential Game-Changing Treatment
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Relamorelin is a Potential Game-Changer Potential rst to market opportunity
Only Ghrelin agonist currently beingevaluated for Diabetic Gastroparesis (DG)
- Diabetic Gastroparesis is delayed
gastric emptying, slowing movementof food through the GI system
Twice daily subcutaneous injection
Alternative formulations underconsideration
Exploring additional indications
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A. Lembo, et al. Lead Late-Breaker Presentation DDW June 2014.1. mITT=modied intention to treat population; 2. Subgroup of patients with vomiting symptoms at baseline. 3. Vomiting severity measured on a 0-10 scale.N=67-69/group in the mITT population.
Relamorelin Improved Gastric Emptying
and Vomiting (Phase 2a Study)
Placebo RM-131 10mcg BID
-1.5
-1.1
-0.8
-0.4
0.0
p=0.005
p=0.006
Vomiting Severity3
-5
-4
-3
-1
0
p=0.041
p=0.033
Weekly Vomiting Episodes
mITT1 Subgroup2 mITT Subgroup
~60% Improvement vs Placebo in Vomiting Symptoms
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Relamorelin: Rapid Recruitment in Phase 2b
Data Anticipated in Mid-2016 Randomized, double-blind, placebo-controlled, stratified, multiple-dose
and multi-national study
~ 395 patients with Type 1 Diabetes Melitus or Type 2 Diabetes Melitus who have both delayedgastric emptying at baseline and moderate to severe DG symptoms and 1 vomiting episodes perweek in Run-in Period
Study Endpoints:- Primary Endpoint:
Change-from-baseline to week 12 in number of vomiting episodes per week
- Secondary Endpoints: Change-from-baseline:
- DG symptoms (various combinations of up to 5 DG symptoms)- Gastric Emptying
Recruitment is on schedule
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Relamorelin is a Novel Prokinetic
Actavis Market Research Study & Rhythm Patient Survey
Percent of Patients Reporting Unsatisfactory Relief
0%
20%
40%
60%
80%
Mild Moderate Severe
2.3MPatients
0.3
0.6
0.9
1.2
US Diabetic Gastroparesis Patients
Mild
Moderate
Severe
~ $6 billion in market potential Prokinetics are a multi-billion dollar market
Needed alternative given the limitations of metaclopramide(Reglan) and the withdrawal of cisapride (Propulsid)
Need for an effective/safe prokinetic
ro ne cs ea - ear x
TRx(M
M)
0
2
4
6
8
10
Propulsid (1998) Reglan (2008)
Prior prokinetics
>$1B>$1B
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Scale and Leadership Gives Us Expansion Opportunities
into Multi-Billion Dollar Adjacencies by 2020
$9.4B
Ulcers
$1.3BDigestives$2.2B
IBS-D
$2.9B
ChronicConstipation& IBS-C
$5.9BUlcerative
Colitis
$5.1BGERD
$8.9B
CrohnsDisease
$2.1BObesity*
$1.4BEmesis
$0.6BDiarrhea
$2BUndevelopedMkt (NASH)*
Figures are illustrative; *Allergan estimateSource: EvaluatePharma, IMS Analytics Link
Allergan presence
No / Limited Allergan presence
Gastrointestinal
$1.5BGall Bladder
Disease
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CNS
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in Action
Use Open Science Modelto Sustain Leadership
Underlying Logic behindCNS Strategy
Leading Therapies In:
MoodDisorders
Migraine
AlzheimersDisease CGRP
Psychosis
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9
RapastinelMDD
AGN-241689Migraine Prophylaxis
Ubrogepant
Acute Migraine
BotoxMDD
VraylarMultiple
SempranaAcute Migraine
VraylarBipolar Depression
Botox X
Spasticity
AGN-241660MDD
CNSP1
P2
P2
P2
P3
P3
P2
P1
P1
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Delivering and Building a Leading CNS PipelineIn-license 2 Merck oral CGRP antagonists
Naurex acquisition- Two rst-in-class differentiated therapies for MDD under development- Research Collaboration with Aptinyx on small molecules
Vraylar(cariprazine) FDA approval for schizophrenia and bipolar maniatype I 9/2015
Saphris(asenapine) FDA pediatric approval for schizophrenia andBipolar mania 3/2015
sNDA submitted memantine/donepezil FDC for Alzheimers on 9/20151
1Initiating patients on FDC for patients stabilized on Donepezil
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MIGRAINEALLERGAN
CGRPs
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Building a Migraine Powerhouse
Triptans
Semprana
Ubrogepant
AGN-241689 AGN-241689
Botox
CGRPsmAbs
Migraine Prophylaxis
Ubrogepant is for rst-line treatment of acute
Semprana alternative for triptan non-responders
AGN-241689 rst line option for migraine prophylaxis
Acute Migraine Frequent Episodic Chronic
Allergan Migraine Product Line Covers Continuum
CGRPsmAbs
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Source: IMS data, Allergan market research
Migraine Prophylaxis is a Large MarketOverview
Large Addressable US Population
$10B US migraine prophylaxismarket, based on topiramateand off-label oral agents
Market could double based onprevalence of disease and newCGRP class
Multi-Billion Dollar Potential Market
US Migraine Patients Seeking Treatment
requent piso ic hronic
~10MM Rxs
~6MM Frequent Episodic andChronic Migraine patientsseeking care
urrent gra neProphylaxis Rx Market
Anticonvulsants
Antidepressants
Beta blockers
CCB
BotoxOther
4MM
2MM
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Full Spectrum Migraine Portfolio
Type ofTreatments
AGN For
Migraine
Type ofMigraine
Episodic
Severe headache that comeson suddenly. Less than 15headache days per month
Chronic
More than 15 headache daysper month over a three monthperiod
Acute (abortive)
Reverse, or stop, theprogression of a headache
Preventive (prophylaxis)
Reduce the frequencyand severity of the migraineattack
Semprana: resolving CMCissues, anticipated launch2017
Ubrogepant (Oral CGRP)Initiate Phase 3 in 2016
Botox !only Rx in the market
AGN 241689 (Oral CGRPfor prevention) Ph2, expectedlaunch 2021
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Potential First in Class Oral CGRP for Acute
and Prophylaxis Treatment of Migraine
Ubrogepant AGN-241689
Indication Acute Treatment of Migraine Prevention of Episodic and Chronic Migraine
Development status Phase 2 completed
Phase 3 program to start 2016
Phase 1 completed
Phase 2 dose-nding study to be conducted
Value Proposition
Ubrogepant efcacy to be comparableto triptans with better tolerability
Alternative for patients for whom triptansare not optimally effective and for those whodo not tolerate triptans
Alternative for triptan intolerant patients or
not well controlled patients
Efcacy comparable to CGRP mAb in development
Alternative to preventive medications (propranolol,topiramate, divalproex sodium) that are ineffectiveor not well tolerated in patients
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Ubrogepant Achieves Acute Pain Relief
and Migraine Freedom at 2hrs in Phase 22-hr Pain Freedom
Proportion Responding (95% CI)
0
10
20
30
40
Placebo 1mg 10mg 25mg 50mg 100mg
PF 2
2-hr Total Migraine FreedomProportion Responding (95% CI)
0
10
20
30
40
Placebo 1mg 10mg 25mg 50mg 100mg
TMF 2
For our phase 3 program, 2 hour pain freedom will be a co-primary endpointalong with absence of the most bothersome associated migraine symptom
(either photophobia, phonophobia, or nausea) at 2 hours post dose.Pooled data P006 & P007
(p=0.318)
(p=0.140)
(p=0.002)
(p=
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Merck data on le
Ubrogepant sub-analyses showed historical triptans responsedid not appear to affect efcacy
Ubrogepant Demonstrates Equal Efficacy
in High and Low Triptan Responders
Triptan response was categorized as:
- High Responders (Those who typically respond to triptans greater than or equal to 75% of the time);- Low Responders (Those who typically respond to triptans less than 75% of the time OR those who
no longer take triptans due to a lack of efcacy);
- Triptan Naive (Those who have never taken a triptan);
Ubrogepant
Pain Free 2HR Placebo 25mg 50mg 100mg
N=113 N=104 N=106 N=102
Triptan HighResponders 11.4% 25.8% 20.7% 21.4%
Triptan LowResponders 11.8% 23.8% 25.9% 21.7%
Triptan Naive 5% 17.9% 23.7% 28.9%
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Merck data on le
Ubrogepant has Favorable AE Profile
in Phase 2 (PN006) Overall AE rates similar to placebo, no signicant differences
No events occurred in more than 7 participants
Low rates or triptan-associated AEs
Ubrogepant
(%) Placebo 25mg 50mg 100mg
Dry Mouth 3.5% 2.9% 3.8% 4.9%
Nausea 3.5% 4.8% 6.6% 6.9%
Fatigue 2.7% 1.9% 0.9% 2.9%
Dizziness 0.9% 1.9% 1.9% 5.9%
Somnolence 5.3% 4.8% 2.8% 3.9%
Triptan-associatedAEs 2.7% 1.0% 1.9% 0%
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Differentiated Structure and Metabolism ProfileUbrogepant/AGN-241689:
No anilide substructure, thus no anilinemetabolite
- Metabolism of anilines can form chemically reactivenitrosamine intermediates
Has a methyl substituted lactam instead ofa piperazinone moiety so chemically reactivediuorophenylglyoxal metabolites cannotbe formed
Diuorophenyl rings in MK-0974 and MK-3207
are replaced with a phenyl group in Ubrogepantand a triuorophenyl group in AGN-241689,respectively
MK-0974(telcagepant)
MK-3207
Ubrogepant AGN-241689
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Ubrogepant and AGN-241689 Liver Profile Telcagepant and MK-3207 are thought to be metabolically activated to form
reactive intermediates that have the potential for producing liver toxicity*
Development of Ubrogepant and AGN-241689 will include robust safety monitoring to assess hepatic safety
Additional modeling planned to better understand telcagepants mechanism of hepatotoxicity and provideopportunity to distinguish Ubrogepant & AGN-241689 from the predecessor molecules
*The precise mechanisms responsible for the liver toxicity produced by telcagepant and MK-3207 remain unknown
Specific design modifications were made to both Ubrogepant and
AGN-241689 to prevent the formation of potentially reactive metabolitesand to increase the potency to decrease body burden
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Source: Company press releases, Allergan and Merck market research, IMS data
POC established for anti-CGRP class Oral preferred over injectables
Impressive efcacy in both Frequent Episodic and ChronicMigraine prophylaxis
- 50-70% of patients experience>50% reduction in headachefrequency
- 10-20% of patients arehyper-responders (75-100%reduction in headachefrequency)
Safety/tolerability prole comparesfavorably to SOC
%o
fpatientspreferringRoA
at ent o re erence
0%
20%
40%
60%
80%
100%
Mode of Administration
Oral QD Oral BID
SC 1x3 mo SC 1xmoSC 1x2 wks IV 1x3 mo
Ubrogepant & AGN-241689 the Oral Anti-CGRPs
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Source: Company press releases, Allergan and Merck market research, IMS data
13%
25%
Oct-09 Jul-10 Apr-11Jan-12Oct-12 Jul-13 Apr-14Jan-15
AUBAGIO AVONEX Total BETASERONCOPAXONE/generics GILENYA REBIF TotalTECFIDERA
U.S. MS Market TRx Share
0%
13%
25%
38%
50%
Mar-18 Jun-18 Sept-18 Dec-18 Mar-19 Jun-19 Sept-19
Humira Enbrel Cimzia OtezlaSimponi Stelara Remicade Cosentyx
U.S. Psoriasis Market TRx Share
Orals have Performed Well in Crowded Markets
with Established mAbs
Otezla
Tecfidera
Gilenya
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DEPRESSION
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Long History of Success in Depression Developed and commercialized 4 anti-depressants
2 anti-depressants reached $1-2B
Excellent understanding of MDD market and psychiatry community
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Rapastinel Could Transform Treatment of MDD
MaintenanceRecovery
Relapse
Rapastinel could be used as both acute and maintenance medication for MDD
SNRIs
Atypicals
SSRIs
Maintenance
Need for AcuteTreatment
Relapse Relapse
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Treatment effects evolve slowly,adverse events begin quickly1
30-50% of the treated patients
respond to their
rst antidepressant1
Getting the right medicine is a trial
and error process
Significant Medical Need Remains in DepressionAvailable anti-depressants
Typical time course ofimprovement with antidepressants
-18
-13.5
-9
-4.5
0
0 7 14 28 42 56
Placebo (n=191)ESC 10mg (n=580)ESC 20mg (n=506)
Day
M
eanchangeinHAM-D
21
1 STAR*D Study:Trivedi Mlt, et al. Am J Psychiatry 2006; 163 : 28-40
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Aiming for Rapid Acting Anti-depressantsUse of Ketamine
Initial studies showing rapidantidepressant effects with low doseketamine infusions in TRD
- Single IV dose of ketamine leadsto full effect in responders withinhours
- Efcacy of single IV dose lastsa few days in responders
Ketamine induces transient symptomsof dissociation/psychosis and is adrug with high abuse potential
Time course of improvementwith single IV dose of ketamine
-18
-13.5
-9
-4.5
0
0 7 14 28 42 56
Placebo (n=191)ESC 10mg (n=580)ESC 20mg (n=506)
Day
M
eanchangeinHAM-D
21
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Adapted from: Danysz W., Parsons C. G. (1998) Glycine and N-methyl- D-aspartate receptors: Physiological signicance and possible therapeutic applications.Pharmacological Reviews, 50, 597-664.
NMDA Receptor Pharmacology
Rapastinel
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Acquisition of Naurex Offers Novel Game-Changing
Treatment Option for Depression
Rapastinel AGN - 241660
Fast Track by FDA
Antidepressant effect apparent within 2 hoursand lasting for 7 days after a single IV dose
Single dose IV administration also showedpromise of rapid acting antidepressant
IV formulation (1-2 minutes) in clinic/doctors ofce Oral formulation
Generally well tolerated, no indication of dissociation
Phase 3 ready Phase 2 oral formulation
Research collaboration Allergan and Aptinyx
- Preclinical small molecules
- Aim to identify additional molecules with similar moleculesfor oral administration
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Rapastinel Demonstrates Rapid Response
& Sustained Effect After Single Dose Separates from placebo in a matter of hours
Difference is sustained for 1 week after single IV dose
Days after dosing
HDRS-17,differenc
e
fromp
lacebo
-5
-3.75
-2.5
-1.25
0
1 3 7 14
Rapastinel 5 mg/kgRapastinel 10 mg/kgRapastinel 30 mg/kg
*
*
*
*
* p
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Rapastinel has No Psychotomimetic Effects
After Single Dose
0 2 4 6 8 10 120
2
4
6
8
10Placebo
1 mg/kg
5 mg/kg
10 mg/kg
30 mg/kg
GLYX-13
Time after dosing, hrs
BPRS+
No psychotomimetic effectsat any timepoint with Rapastinel:
Ketamine psychotomimetic effectsare evident within the rst two hours:
Berman et al. 2000
Brief Psychiatric Rating Scale (BPRS): scale used to measure psychiatric symptoms such as depression and anxiety, symptoms rated on scales from 1-7
Rapastinel
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Rapastinel Well Tolerated After Single Dose
Most Common Treatment Emergent Adverse Events (>10% of Subjects)
Adverse Event Rapastinel4 dose groups (n=83)
Placebo (n=33)
Any Event 71% 63%
Headache 17% 18%
Somnolence 12% 6%
Dizziness 10% 0%
Dysgeusia 7% 9%
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Rapastinel: Recent Studies Suggestive of Efficacy
and Tolerability and Patients Remain on Therapy
Phase 2b: Repeat Dose Study Open Label Study
# Rapastinel was administered adjunctivelyover 12 weeks with an SSRI or SNRI tosubjects who had partially responded(
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Rapastinel has Blockbuster Potential
24MM People for MDD
TreatmentResistant MDD
Suicidal Thoughts& Behaviors
ener c
Multi-billion Dollar Market
30-40%
TreatmentSettings
Office Setting Outpatient Clinic Hospital
Utility in multiple treatment settings
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VRAYLAR
(CARIPRAZINE)
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Most antipsychotics are D2 receptor antagonists
Abilify and Vraylar are partial D2 agonists Vraylar is a partial agonist with unique D3 activity
Low propensity for weight gain and metabolic changes
Good efcacy in multiple indications
VRAYLAR is Unique from Other Antipsychotic
Novel MOA
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Robust Efficacy Across Multiple IndicationsSchizophrenia
Type I DisorderFDA approval 9/15
FDA approval 9/15
Bipolar Mania
MDD Adjunct
NegativeSymptoms
Phase 3 Ongoing
Phase 2 CompletedBipolarDepression
Additional data supports efficacy and prevention of relapse
No drugs are approved for negative symptoms
Mania data demonstrates a large treatment effect
Additional data in Bipolar Depression also supports efficacy and safetyin treating bipolar patients with depressive symptoms
Only two other atypical antipsychotic agents have shown efficacy in thisdomain (quetiapine and lurasidone)
Positive Phase 2 data demonstrating cariprazines efficacy inadjunctive treatment of MDD
Gedeon RichterPhase 2 Completed
Indication Would Differentiate from Any Other Product on the Market
1
2
3
4
5
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VRAYLARSafe, Effective Treatment for Schizophrenia
PANSS: Positive and Negative Symptoms ScaleYMRS: Young Mania Rating Scale
1Schizophrenia
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Negative Symptoms Hinder Social Interactions
Lack of pleasure in everyday life
Lack of ability to begin and sustain activities
Face does not move with emotion
Talk in dull or monotonous voice
Negative Symptoms
Symptoms such as hallucinations,delusions, thought disorders
Positive Symptoms
No approved drugfor Negative Symptoms
Often addressed by currentlyavailable therapies
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VRAYLAR Demonstrates Convincing Efficacy
in the Treatment of Negative Symptoms Demonstrated signicant effect on treatment of negative symptoms versus
risperidone in a 26-week double-blind comparator controlled study in 461patients with predominant negative symptoms of schizophrenia
Demonstrated improvement on both efcacy (PANSS-NFS) and function (PSP)
PANSS-NFS: Positive and Negative Symptom Score of Schizophrenia- Negative Factor ScorePSP: Personal and Social Performance
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Negative Symptom Claim Would
be Key Advantage for VRAYLAR
53MM
13MM
5MM
Market Prescriptionsfor Atypicals
~25% Schizophrenia
~40% NegativeSymptoms
Atypical Anti-Psychotics
Negative SymptomMarket Segment Value $3B
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VRAYLARSafe, Effective Treatment for Bipolar Mania
2 Manic or Mixed Episodes Associatedwith Bipolar I Disorder
PANSS: Positive and Negative Symptoms ScaleYMRS: Young Mania Rating Scale
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VRAYLAR as an Adjunct to Antidepressants
in the Treatment of MDDAdjunct MDD3
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VRAYLAR was Effective in the Treatment
of Bipolar DepressionBipolar Depression4
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Pharmacologically different: D2/D3partial agonist
Clinically, Vraylar has tolerabilityadvantages over other atypical
anti-psychotics Bipolar Depression and MDD
are fastest growing segments
Vraylar will be launched in two stages
- Stage 1: Schizophrenia & Mania
- Stage 2: MDD, NegativeSymptoms, and BipolarDepression
1. Other (Autism, ADHD, OCD, Anxiety, other personality disorders total $6 billion and not included in estimate above GfK Schizophrenia Physician Study 2013
VRAYLAR has Potential in Multiple Indications
$5.1B$7B $3.3B$2.1B
Schizophrenia Mania BP Dep MDD
$15$20B in Sales
Treatment Failure Rates are High
28%Switch dueto efficacy
32%
Switch dueto sideeffects
Over 50%of patientsfail 2ndline
therapy
Weight Gain EPS Somnolence
Anti-Psychotic Market Potential1
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1. Schizophrenia Placebo Adjusted data based on package inserts.2. Akathisia:97% reported as mild/moderate. Discontinuation rate 0.5%Vraylar weight reects recommended doses. For somnolence and akathisia, data reects average of recommended doses.For Risperdal, data reects 1-8mg/day which is the most commonly used dose range in schizophrenia as two dose ranges are included in PIMost package inserts, somnolence is reported as a group term including somnolence and sedation. Rexulti PI only reports sedation.
Vraylar has a Competitive Risk Profile
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
Zyprexa 19%
Seroquel 17%
Vraylar 3%
Risperdal 6% Seroquel XR 5% Abilify 5%
Rexulti 6-7%
Latuda 2%
Saphris 3%
Weight >7%1
Risperdal 7%
Abilify 6%
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
Zyprexa 4%
Seroquel 0%
Vraylar 7%
Seroquel XR 1% Rexulti 1%
Latuda 10%
Saphris 3%
Akathisia1,2
Risperdal 8%
Abilify 5%
20%
18%
16%
14%
12%
10%
8%
6%
4%
2%
0%
Zyprexa 16%
Seroquel 10%
Vraylar 2%
Seroquel XR 15%
Rexulti 1%
Latuda 10%
Saphris 6%
Somnolence1
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VRAYLAR has Blockbuster Potential
Vraylar will be launched in two stages
- Stage 1: Schizophrenia & Mania
- Stage 2: MDD, Negative Symptoms,and Bipolar Depression
Superior tolerability prole in termsof weight gain and metabolic effect
2015 2018 2019 2020
SchizophreniaBipolar Mania
BipolarDepression
Negative Symptomin schizophrenia
5 Potential Indications withCombined Potential >$1B
MDD
$1B+
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Scale and Leadership Gives Us Expansion Opportunities
into Multi-Billion Dollar Adjacencies by 2020
Parkinsons
$4BParkinsons
$7BDepression
$7BAlzheimers
$3BMigraine
$9BSchizophrenia
$8BEpilepsy
$25BMultipleSclerosis
$0.3BHuntingtons
$4B
SleepDisorders
$5BADHD
Figures are illustrativeSource: EvaluatePharma, IMS Analytics Link
Allergan presence
No / Limited Allergan presence
Central Nervous System
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HERBERT Y.
Professor of Psychiatry and Behavioral Sciences,Pharmacology, and Physiology
Northwestern University
MELTZER M.D.
STEVEN G.
POTKIN M.D.Professor Department of Psychologyand Human Behavior
University of California, Irvine
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WOMENS HEALTH& UROLOGY
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in Action
Use Open Science Modelto Sustain Leadership
Underlying Logic behind Our WH & URO Strategy
Building and Delivering
Contraception Gynecology
Urology
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Womens Health
EstradiolVaginal Cream VVA & Dyspareunia
UlipristalFibroids
EstradiolVag Caps VVA & Dyspareunia
Etonogestral RingContraception P3
P3
P1
P14
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Developing and Building
the WH and Urology PipelineLiletta(levonorgestrel-releasing intrauterine system) FDA approvalFebruary 2015, (2-handed inserter) launched 3/2015 sNDA Single Handed Inserter February 2016 approval targeted
Diafert EU approval for diagnostic for infertility March 2015
Esmya Phase 3 trials; patient screening completed
SER-120 Phase 3 Topline results met endpoints
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ESMYA (ulipristal) is a First in Class Selective
Progesterone Receptor Modulator (SPRM) Laproscopic power morcellators for broids recalled; concerns regarding spread
of malignant cells
2 ongoing Phase 3 studies in US target indication for treatment of abnormal uterinebleeding in women with leiomyomas:
UL-1208 UL-1309
Target of 400 planned patients Target of 150 planned patients
5mg and 10mg Ulipristal, 2 treatment cycles 5mg and 10mg Ulipristal, 1 treatment cycle
Topline data expected 2017Topline data expected 2016.Randomization completed
Co-primary endpoints% of patients who achieve absence of bleeding dueto uterine broids during 1sttreatment cycle, time to
absence of bleeding
Secondary endpoints Absence of bleeding at day 11 Symptom severity on a broid symptom scale Quality of life
Expected NDA submission 2017 with expected approval 2018
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Ulipristal Has Proven Efficacy and Safety With
Long-Term Intermittent Therapy Approved in EU Long term treatment - STET treatment courses of 12 weeks each approved in EU (May 2015 )
for treatment of moderate to severe symptoms of uterine broids
Pearl IV data demonstrated efcacy was maintained and safety prole was unchangedwith the repeated courses of therapy !support intermittent and long term use
aAmenorrhea dened as no more than one day of spotting within a 35-day intervalbPatients with missing values were excluded from the analysiscN and % include withdrawn patientsdData from EU SPC: May 27, 2015
atents
After treatment course 2 After treatment course 4
5 mg10 mg
PEARL IVN= 205 N= 197
PEARL IVN= 227 N= 220
Percent of Patients in Amenorrheaa,b,c,d
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Reduces tumor size, relieves pain and bleeding, and time to surgery
Esmya (ulipristal acetate)
Breakthrough Treatment for Uterine Fibroids
Large market with over 10 million women
Women 25-49 in US52MM
Women at Risk forUterine Fibroids
36MM
Diagnosed withUterine Fibroids11MM
r sta rescr pt ons
0
2,500
5,000
7,500
10,000
Q3 13 Q1 14 Q3 14 Q1 15 Q3 15
Successful launch in Canada
Canadaperformance in US
terms points to$1B opportunity
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UrologyBotoxPremature Ejaculation
LiRISInterstitial Cystitis
SER-120Adult Nocturia
BotoxIndication X
P2
P3
P2
PC
4
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SER-120 for the Treatment of Nocturia
Developed in collaboration withSerenity Pharmaceuticals
Novel low dose desmopressin(synthetic analog of vasopressin)nasal spray for the treatment ofnocturia in adults
Leads to reduction in urineproduction and postpones theneed for voiding
Unique pharmacokinetic prolewith short overnight action whendosed in evening
Nocturia becomes more prevalentafter the age of 50 years
Affects about 25-34% of thepopulation aged 50 years andolder
Often associated with other lowerurinary tract symptoms as OAB/overactive bladder and BPH/benign prostatic hyperplasia
Nocturia: UnmetClinical Need
SER-120(desmopressin nasal spray)
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4 placebo-controlled phase 3 studies completed(DB1, DB2, DB3, DB4)
DB3 study: 0.75mcg, 1.0mcg, 1.5mcg (doubleblind placebo phase completed Nov. 2012),including Open label long term extension
(completed in June 2015)
DB4 study: 0.75mcg, 1.5mcg, placebo; nalphase 3 study (completed May 2015)
DB3 and DB4 pivotal studies with a 12 weekrandomized double-blind period: bothdemonstrated statistical signicance overplacebo in reduction of nocturic episodes
SER-120 Phase 3 Studies CompletedDevelopment status in US
Ongoing FDA interactions to prepare
for submission Submit US NDA in 2016
Start European development in 2016
Next Steps
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Scale and Leadership Gives Us Expansion Opportunities
into Multi-Billion Dollar Adjacencies by 2020
Allergan presence
No / Limited Allergan presence
$2.8B
IBS-C
$5.8BHormone Therapy /
MenopauseManagement
$1.3BEndometriosis
$5.8BHormonal
Contraception
$1BUterineFibroids
$1.5BFertility
$0.5BFemale SexualDysfunction*
$0.3BNon-Hormonal
IUDs
$0.3BGU Anti-Infectives
Figures are illustrative; *Allergan estimateSource: EvaluatePharma, IMS Analytics Link
Womens Health
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ANTI-INFECTIVE
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in Action
Use Open Science Modelto Sustain Leadership
Underlying Logic behind Our Anti-lnfective Strategy
Building and DeliveringGRAM-POSITIVE
ABSSSICABP
Osteomyelitis
GRAM-NEGATIVEcUTI
cIAI
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5
Anti-Infective
AvycazcUTI, cIAI
Dalbavancin Osteomyelitis
Dalbavancin Endocarditis
Dalbavancin ABSSSISingle Dose
P3
R
P3
P3
Aztreonam/AvibactamGram Neg InfectP2
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Delivering and Building the AI PipelineAVYCAZ(ceftazidime-avibactam)
Approved February 2015 for cIAI, cUTI
sNDA ling with Phase 3 cIAI 4Q2015
sNDA ling with Phase 3 cUTI 2016
DALVANCE(dalbavancin) EU approval (ABSSSI) March 2015
sNDA ling for single dose for ABSSSI on July 2015
TEFLARO(ceftaroline fosamil) sNDA for bacteremia and short infusion approved in August 2015
AZTREONAM/AVIBACTAM
Gram-negative pathogens
Different microbiological prole than Avycaz
Initiating development
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In Gram-negative pathogens resistant to ceftazidime, ceftazidime-avibactam plus metronidazole resulted in:
Similar clinical cure rate to meropenem
Similar clinical cure rate to ceftazidime-susceptible pathogens
CAZ-AVI + MTZ(n=413)
MER(n=410)
ComparisonBetween Groups
Pathogen n Clinical Curen (%) nClinical Cure
n (%)Difference, %
(95% CI)
All ceftazidime-resistant
47 39(83.0)
64 55(85.9)
3.0(17.89, 10.60)
All ceftazidime-susceptible
289 237(82.0)
292 256(87.7)
5.7(11.57, 0.17)
with Ceftazidime-Resistant Bacteria (RECLAIM data)is Effective in Treating cIAI Patients Infected
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is Effective in Treating cUTI (RECAPTURE data)Avycaz demonstrated non-inferiority compared with doripenemsymptomatic resolution and favorable microbiological response at test-of-cure in the mMITT population
Numerical response trend in favor of Avycaz for microbiological response
and combined symptomatic/microbiological response at test-of-cure
Avycaz was effective in treating cUTI patients infected withceftazidime-resistant bacteria
sNDA to be filed 2016 with aim of removing limitation statement for cUTI
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Key New Product Launch Performance
Zerbaxais a registered trademark of MerckOrbactivis a registered trademark of Medicines Company
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Medicines Co.
Dalvance
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