Table of Contents
ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the anxiety market
- Key metrics
CHAPTER 2 PATIENT POTENTIAL
- Etiology of anxiety disorders
- Generalized anxiety disorder
- Panic disorder
- Social anxiety disorder
- Obsessive-compulsive disorder
- Post-traumatic stress disorder
- Premenstrual dysphoric disorder
- Agoraphobia
- Specific phobias
- Classification of anxiety disorders
- ICD-10 classification
- DSM-IV classification
- Diagnosis algorithm
- Epidemiology of anxiety
- Prevalence of anxiety disorder types
- Generalized anxiety disorder
- Panic disorder
- Social anxiety disorder
- Obsessive-compulsive disorder
- Post-traumatic stress disorder
- Premenstrual dysphoric disorder
- Agoraphobia
- Specific phobias
- Other anxiety disorders
- Key patient segments
- Acute versus chronic anxiety
- Gender and age
- Comorbidities of anxiety disorders
- Unmet needs in anxiety disorders
- Improving patient compliance is key
- Improving the perceived therapeutic efficacy throughpatient education
- Patient education and public awareness
- Faster onset of action on the horizon
- Limiting side effects is essential
- Targeting comorbidity expands the prescribing potential ofa drug
CHAPTER 3 R&D APPROACH
- Classification of marketed and pipeline products
- Serotonergics
- Noradrenergics
- GABAergic drugs
- Novel therapies
- Clinical trials and drug development
- Clinical trial endpoints and anxiety rating scales
- Hamilton Anxiety (HAM-A)
- Hospital Anxiety and Depression scale (HADS)
- Liebowitz Social Anxiety Scale (LSAS)
- Patient Global Impression of Improvement Scale (PGI)
- Clinical Global Impression Improvement Scale (CGI-I)
- Social Phobia and Anxiety Inventory (SPAI)
- Social Phobia Inventory (SPIN)
- Clinician Administered PTSD Scale (CAPS)
- Treatment Outcome PTSD Scale
- Davidson Trauma Scale (DTS)
- Short PTSD Rating Interview (SPRINT)
- Brief Social Phobia Scale fear subscale
- Panic Disorder Severity Scale (PDSS)
- Panic and Agoraphobia Scale (PAS)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
- The National Institute of Mental Health ObsessiveCompulsive Scale
(NIMH-OC)
- Daily Record of Severity of Problems (DRSP)
- Other scales
- Clinical trial design guidance
- Inclusion criteria
- Exclusion criteria
- Assessing efficacy
- Strategy and design of clinical trials
- Key research recommendations
CHAPTER 4 MARKETED AND PIPELINE ANXIETY DRUG OVERVIEW
- Marketed anxiety drug overview
- The market value is calculated using IMS diagnosis value
- Forecast caveats
- Pipeline overview
- Anxiety drugs in Phase III and above
- Anxiety drugs in Phase II
- Anxiety drugs in Phase I
- Key companies involved in the anxiety pipeline
- Other key companies involved in the anxiety pipeline
- Sanofi-Aventis
- Fabre Kramer
- Methodology of SWOT analysis
- Gold standard anxiolytic
- Generalized Anxiety Disorder
- Obsessive Compulsive Disorder
- Panic Disorder
- Social Anxiety Disorder
- Premenstrual Dysphoric Disorder
- Post traumatic stress disorder
CHAPTER 5 GAD PIPELINE DRUG OVERVIEW
- Overview of GAD drugs
- Launched drugs
- Pipeline summary
- Lyrica (pregabalin)
- Cymbalta (duloxetine)
- Clinical trial data
- Recently completed clinical trials
- Ongoing clinical trials
- PRX-00023
- Clinical trial data
- Ongoing clinical trials
- SR-58611
- Gabitril (tiagabine)
- Clinical trial data
- Ongoing clinical trials
- Seroquel SR (quetiapine sustained release)
- AC-5216
- MN-305 (osemozotan / MKC-242)
- Jazz Pharma
- Recently discontinued pipeline drugs
CHAPTER 6 OCD PIPELINE DRUG OVERVIEW
- Overview of OCD drugs
- Launched drugs
- Pipeline summary
- Lexapro (escitalopram)
- Clinical trial data
- Ongoing clinical trials
- Luvox CR (fluvoxamine controlled release)
CHAPTER 7 SAD PIPELINE DRUG OVERVIEW
- Overview of SAD drugs
- Launched drugs
- Pipeline summary
- Luvox CR (fluvoxamine controlled release)
- Lexapro (escitalopram)
- Cymbalta (duloxetine)
- TGWOOAD/AA
- LY686017
- Gabitril (tiagabine)
- Clinical trial data
- Completed clinical trials
- casopitant (GW679769)
CHAPTER 8 PD PIPELINE DRUG OVERVIEW
- Overview of PD drugs
- Launched drugs
- Pipeline summary
- Lexapro (escitalopram)
- TGAR01P
CHAPTER 9 PTSD PIPELINE DRUG OVERVIEW
- Overview of PTSD drugs
- Launched drugs
- Pipeline summary
- Risperdal (risperidone)
- Clinical trial data
- Ongoing clinical trials
- Paxil CR (paroxetine controlled release)
- Gabitril (tiagabine)
- Effexor XR (venlafaxine extended release)
CHAPTER 10 PMDD PIPELINE DRUG OVERVIEW
- Overview of PMDD drugs
- Launched drugs
- Pipeline summary
- YAZ (drospirenone and ethinyl estradiol)
- Librel (levonorgestrel / ethinyl estradiol)
CHAPTER 11 NON-SPECIFIED ANXIETY DISORDERS DRUG OVERVIEW
- Non-specified anxiety disorders drug overview
- Launched drugs
- Pipeline summary
- alprazolam
- AP-521
- ELB139
- vestipitant (GW597599) + paroxetine
- Recently suspended pipeline drugs
CHAPTER 12 ANALYSIS AND FORECASTS OF PIPELINE ANXIETYDRUGS
- Analysis and forecasts of pipeline anxiety drugs
- Lyrica (pregabalin)
- Lyrica demonstrates a strong safety and efficacy profile,with a fast
onset
- Schedule V may limit patient uptake in the US
- Lyica will become a first-line treatment for pure GAD
- Lyricas anxiety revenues will slow the decline ofPfizers anxiety
franchise
- Threat from generic gabapentin?
- Lyrica will be the next new anxiety drug to reach themarket
- Cymbalta (duloxetine)
- Cymbaltas side effects will limit uptake in anxiety
- Lack of clear differentiation from venlafaxine in anxiety
- Global partnerships enhance commercial prospects ofCymbalta
- Cymbaltas revenue growth in the anxiety market will beshort lived
- PRX-00023
- Physicians are unconvinced with the therapeutic potentialof PRX-00023
- PRX-00023 will be used to augment SSRI therapy
- PRX-00023 is unlikely to compete on the same therapeuticplain as the
SSRIs
- SR-58611
- Efficacy in severe depression may carry over into anxiety
- Initial off-label usage will support growth in GAD onceapproved
- Gabitril (tiagabine)
- Physicians unimpressed by Gabitrils efficacy in anxiety
- FDA seizure warning severely threatens Gabitrils patientpotential
- Treatment of comorbid pain in GAD
- Gabitrils commercial potential is limited
- Gabitril is unlikey to receive FDA approval for GAD
- Seroquel SR (quetiapine sustained release)
- A strong safety and efficacy profile in schizophrenia andBD bodes
well for use in anxiety
- Seroquel will retain patent protection until 2011,protecting the
initial uptake of Seroquel SR
- Targeting community based psychiatric disorders will favorSeroquel
SRs growth
- AC-5216
- Physicians are skeptical of the therapeutic potential ofAC-5216
- MN-305 (Osemozotan / MKC-242)
- The record for the 5-HT1A partial agonists has beenappallingly bad
- MediciNova will need to find a marketing partner
- Jazz Pharma
- Lexapro (escitalopram)
- US non-approvals for SAD and PD will limit future revenues
- Lack of pipeline compounds will limit long-term anxietyrevenues for
Lundbeck and Forest
- Lexapro will retain patent protection until 2011
- Lexapros anxiety specific revenues will continue to growthrough 2009
- Luvox CR (fluvoxamine controlled release)
- Luvox will continue to grow in Japan, despitegenericization
- Luvox CR is commercial suicide
- TGWOOAD/AA
- TGWOOAD/AAs mode of action is not particularly unique
- Fabre Kramer will need to find a marketing partner
- TGAR01P
- Physicians have serious concerns regarding TGAR01P
- Datamonitor does not expect that TGAR01P will receive FDAapproval
- LY686017
- Risperdal (risperidone)
- Risperdal demonstrates efficacy in reducing the symptomsof PTSD
- J&J has limited time to gain FDA approval forRisperdal for PTSD
before the availability of generic risperidone
- Paxil CR (paroxetine controlled release)
- GSK faces several hurdles in terms of establishing PaxilCR as a
first-line treatment for PTSD
- GSKs NK1 antagonists - casopitant (GW679769) andvestipitant (GW597599)
- Combination of an NK1 antagonist and SSRI shows potential
- Effexor XR (venlafaxine extended release)
- Effexor XRs recent approval for PD will certainly boostrevenues
- US and EU patent expiries lead to erosion of Effexor XRrevenues from
2008 onwards
- YAZ (drospirenone and ethinyl estradiol)
- YAZ will provide an alternative treatment to women whofeel that
there is a stigma attached to taking an SSRI
- No PMDD market in the EU limits revenue potential
- YAZ is expected to continue to grow Schering AG/Berlexsflagship
womens health franchise
- Librel (levonorgestrel / ethinyl estradiol)
- Librels continuous regimen may provide a competitiveadvantage
- Librels uptake will be limited by YAZs first to marketstatus
- NovaDels alprazolam oral spray
- Improved therapeutic potential remains uncertain despite
ahead-to-head trial with alprazolam tablets
- NovaDel will have difficulty in gaining FDA approval forthe
formulation
- Datamonitor does not expect oral spray alprazolam willreceive FDA
approval
- AP-521
- ELB139
CHAPTER 13 INNOVATIVE EARLY-STAGE PROJECTS
- Overview of innovative early-stage projects
- NK receptor antagonists
- ALXZ-002
- Synthetic human secretin
- The subcutaneous formulation is unlikely be received wellby patients
- CRF antagonists
- 5-HT agonists
- Metabotropic glutamate receptor 5 modulators
- MAO inhibitors
- CCK antagonists
- PDE 2 inhibitor
- Vasopressin
- Future treatment of anxiety disorder
APPENDIX A
- Forecast revenues
- Anxiety market data
- Competitive positioning analysis of pipeline anxiety drugs
- Bibliography
- Journal articles and conference abstracts
APPENDIX B
- Report methodology
- Datamonitor forecast methodology
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcares therapy area capabilities
List of Tables
- Table 1: Forecast revenues ($m) of marketed and pipelineanxiety drugs
across the seven major markets, 2006-15
- Table 2: ICD-10 classification codes for anxietydisorders
- Table 3: DSM-IV classification codes for anxietydisorders
- Table 4: Prevalence rate of sub-categories of anxietydisorder in the
general population across the seven major markets
- Table 5: Prevalence of GAD
- Table 6: Prevalence of panic disorder
- Table 7: Prevalence of SAD in four of the major markets
- Table 8: Prevalence of OCD
- Table 9: Prevalence of a comorbid psychiatric conditionwith anxiety
disorders across the seven major markets
- Table 10: Marketed anxiety drugs approved for specificanxiety disorders,
in the US, EU and Japan.
- Table 11: Percentage of total molecule volume (accountedfor by anxiety,
diagnosis value, 2005 (MAT Q4 2004 to Q3 2005)
- Table 12: Drugs seeking approval for anxietyindications, 2006
- Table 13: Drugs in Phase III development for anxietydisorders, 2006
- Table 14: Drugs in Phase II development for anxietydisorders, 2006
- Table 15: Drugs in Phase I development for anxietydisorders, 2006
- Table 16: GSKs global CNS franchise, 2005
- Table 17: GSKs marketed and pipeline anxiety drugs,2006
- Table 18: Wyeths global CNS portfolio, 2004-05
- Table 19: Wyeths marketed and pipeline anxiety drugs,2006
- Table 20: Lillys global CNS portfolio, 2005
- Table 21: GSKs marketed and pipeline anxiety drugs,2005
- Table 22: Commercial strength / weakness factors -weightings and scoring
definitions
- Table 23: Product specific strength / weakness factors -weightings and
scoring definitions
- Table 24: Drugs approved for GAD
- Table 25: Drugs in Phase II development or above for GAD
- Table 26: Pipeline drugs recently discontinued fromdevelopment for GAD
- Table 27: Drugs approved for OCD
- Table 28: Drugs in Phase II development or above for OCD
- Table 29: Drugs approved for SAD
- Table 30: Drugs in Phase II development or above for SAD
- Table 31: Drugs approved for PD
- Table 32: Drugs in Phase II development or above for PD
- Table 33: Drugs approved for PTSD
- Table 34: Drugs in Phase II development or above forPTSD
- Table 35: Drugs approved for PMDD
- Table 36: Drugs in Phase II development or above forPMDD
- Table 37: Drugs approved for non-specified anxietydisorders
- Table 38: Drugs in late-stage development fornon-specified anxiety
disorders
- Table 39: Pipeline drugs recently suspended fromdevelopment for
non-specified anxiety disorders
- Table 40: Proportion (%) of drug revenues attributed toanxiety disorders
for Gabitril and approved anxiety drugs
- Table 41: Estimated patient and revenue potential of YAZin PMDD
- Table 42: Estimated patient and revenue potential ofLibrel in PMDD
- Table 43: Drugs in Phase I clinical development foranxiety disorders,
2006
- Table 44: Forecast revenues ($m) of marketed andpipeline anxiety drugs
across the seven major markets, 2006-15
- Table 45: Prozac key facts
- Table 46: Key Prozac events, 2005-2006
- Table 47: Prozac key facts
- Table 48: Paxil key facts
- Table 49: Key Paxil events, 2005-2006
- Table 50: Zoloft: key facts
- Table 51: Key Zoloft events, 2005-2006
- Table 52: Celexa: key facts
- Table 53: Lexapro: key facts
- Table 54: Key Lexapro/Cipralex events, 2005-2006
- Table 55: Luvox: key facts
- Table 56: Key Luvox events, 2005-2006
- Table 57: Effexor: key facts
- Table 58: Key Effexor events, 2005-2006
- Table 59: Xanax: key facts
- Table 60: Buspar: key facts
- Table 61: Cymbalta: key facts
- Table 62: Key Cymbalta events, 2005-2006
- Table 63: Lyrica: key facts
- Table 64: Key Lyrica events, 2005-2006
- Table 65: Gabitril: key facts
- Table 66: Key Gabitril events, 2005-2006
- Table 67: Datamonitors competitive positioning analysisof pipeline
anxiety drugs compared to existing market players (1 of 2)
- Table 68: Datamonitors competitive positioning analysisof pipeline
anxiety drugs compared to existing market players (2 of 2)
- Table 69: Anxiety disorders market definition by ICD10code
List of Figures
- Figure 1: Datamonitors forecast for anxiety specificrevenues of
pipeline and marketed anxiety drugs across the seven majormarkets, 2006-15
- Figure 2: Datamonitors SWOT analysis of pipeline drugs.
- Figure 3: Anxiety disorders diagnostic decision tree(DSM-IV)
- Figure 4: Patient distribution: acute versus chronicanxiety
- Figure 5: Reasons why patients receiving antidepressanttherapy are
non-compliant
- Figure 6: Drug classes in development for the treatmentof anxiety
disorders.
- Figure 7: NICE measurement of cost-effectiveness of drugtreatment
- Figure 8: Revenues of the Paxil franchise after genericincursion
- Figure 9: US Drugstore Paxil prescriptions for anxietydisorders, 2003-05
- Figure 10: US revenue split of Paxil and Paxil CRbetween anxiety
disorders and alternative indications, 2002-05
- Figure 11: Forecast revenues of the Paxil franchiseacross the seven
major markets, 2006-15
- Figure 12: US revenue split of the Effexor franchise XRbetween anxiety
disorders and alternative indications, 2002-05
- Figure 13: Forecast revenues of the Wyeths anxietyfranchise across the
seven major markets, 2006-15
- Figure 14: US revenue split of Prozac between anxietydisorders and
alternative indications, 2002-05
- Figure 15: Forecast revenues of Lillys anxietyfranchise across the
seven major markets, 2006-15
- Figure 16: Physician rated performance of main drugsused in the
treatment of anxiety disorders
- Figure 17: Datamonitors SWOT analysis of GAD pipelinedrugs
- Figure 18: Datamonitors SWOT analysis of OCD pipelinedrugs
- Figure 19: Datamonitors SWOT analysis of SAD pipelinedrugs
- Figure 20: Datamonitors SWOT analysis of PD pipelinedrugs
- Figure 21: Datamonitors SWOT analysis of PTSD pipelinedrugs
- Figure 22: Datamonitors SWOT analysis of PMDD pipelinedrugs
- Figure 23: The pharmacologic profile of Lyrica comparedto paroxetine
- Figure 24: Forecast revenues of Pfizers anxietyfranchise across the
seven major markets, 2006-15
- Figure 25: Anxiety specific revenue forecast for Lyricaacross the seven
major markets, 2006-15
- Figure 26: The pharmacologic profile of Cymbaltacompared to paroxetine
- Figure 27: Anxiety specific revenue forecast forCymbalta across the
seven major markets, 2006-15
- Figure 28: The pharmacologic profile of PRX-00023compared to paroxetine
- Figure 29: Anxiety specific revenue forecast forPRX-00023 across the
seven major markets, 2006-15
- Figure 30: The pharmacologic profile of SR5-8611compared to paroxetine
- Figure 31: Quarterly revenues of Gabitril (2004-05)
- Figure 32: The pharmacologic profile of Gabitrilcompared to paroxetine
- Figure 33: US revenue split of Gabitril between anxietydisorders and
alternative indications, 2002-05
- Figure 34: The pharmacologic profile of Seroquel SRcompared to paroxetine
- Figure 35: US revenue split of Lexapro between anxietydisorders and
alternative indications, 2002-05
- Figure 36: The pharmacologic profile of Lexapro comparedto paroxetine
- Figure 37: US cash market share of Forest/Lundbecksantidepressant
franchise from 2002-05
- Figure 38: Anxiety specific revenue forecast for Lexaproacross the seven
major markets, 2006-15
- Figure 39: The pharmacologic profile of Luvox CRcompared to paroxetine
- Figure 40: The pharmacologic profile of TGWOOAD/AAcompared to paroxetine
- Figure 41: The pharmacologic profile of Risperdalcompared to paroxetine
- Figure 42: The pharmacologic profile of Paxil CRcompared to paroxetine
- Figure 43: Anxiety specific revenue forecast for PaxilCR across the
seven major markets, 2006-15
- Figure 44: The pharmacologic profile of Effexor XRcompared to paroxetine
- Figure 45: Anxiety specific revenue forecast for EffexorXR across the
seven major markets, 2006-15
- Figure 46: The pharmacologic profile of YAZ compared toparoxetine
- Figure 47: Anxiety specific revenue forecast for YAZacross the seven
major markets, 2006-15
- Figure 48: The pharmacologic profile of Librel comparedto paroxetine
- Figure 49: Anxiety specific revenue forecast for Librelacross the seven
major markets, 2006-15
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