Pipeline Insight: Anxiety Disorders - A Decade of Declining Revenues

Published by: Datamonitor

Published: Mar. 29, 2006 - 310 Pages

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 through patient education

Patient education and public awareness

Faster onset of action on the horizon

Limiting side effects is essential

Targeting comorbidity expands the prescribing potential of a 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 Obsessive Compulsive 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

GSK

Wyeth

Lilly

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)

Clinical trial data

Cymbalta (duloxetine)

Clinical trial data

Recently completed clinical trials

Ongoing clinical trials

PRX-00023

Clinical trial data

Ongoing clinical trials

SR-58611

Ongoing clinical trials

Gabitril (tiagabine)

Clinical trial data

Ongoing clinical trials

Seroquel SR (quetiapine sustained release)

Clinical trial data

AC-5216

Ongoing clinical trials

MN-305 (osemozotan / MKC-242)

Jazz Pharma

Ongoing clinical trials

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)

Clinical trial data

CHAPTER 7 SAD PIPELINE DRUG OVERVIEW

Overview of SAD drugs

Launched drugs

Pipeline summary

Luvox CR (fluvoxamine controlled release)

Clinical trial data

Lexapro (escitalopram)

Clinical trial data

Cymbalta (duloxetine)

Ongoing clinical trials

TGWOOAD/AA

LY686017

Ongoing clinical trials

Gabitril (tiagabine)

Clinical trial data

Completed clinical trials

casopitant (GW679769)

Ongoing clinical trials

CHAPTER 8 PD PIPELINE DRUG OVERVIEW

Overview of PD drugs

Launched drugs

Pipeline summary

Lexapro (escitalopram)

Clinical trial data

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)

Ongoing clinical trials

Gabitril (tiagabine)

Clinical trial data

Effexor XR (venlafaxine extended release)

Clinical trial data

CHAPTER 10 PMDD PIPELINE DRUG OVERVIEW

Overview of PMDD drugs

Launched drugs

Pipeline summary

YAZ (drospirenone and ethinyl estradiol)

Clinical trial data

Librel (levonorgestrel / ethinyl estradiol)

Ongoing clinical trials

CHAPTER 11 NON-SPECIFIED ANXIETY DISORDERS DRUG OVERVIEW

Non-specified anxiety disorders drug overview

Launched drugs

Pipeline summary

alprazolam

AP-521

ELB139

Clinical trial data

vestipitant (GW597599) + paroxetine

Recently suspended pipeline drugs

CHAPTER 12 ANALYSIS AND FORECASTS OF PIPELINE ANXIETY DRUGS

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

Lyrica's anxiety revenues will slow the decline of Pfizer's anxiety franchise

Threat from generic gabapentin?

Lyrica will be the next new anxiety drug to reach the market

Cymbalta (duloxetine)

Cymbalta's side effects will limit uptake in anxiety

Lack of clear differentiation from venlafaxine in anxiety

Global partnerships enhance commercial prospects of Cymbalta

Cymbalta's revenue growth in the anxiety market will be short lived

PRX-00023

Physicians are unconvinced with the therapeutic potential of PRX-00023

PRX-00023 will be used to augment SSRI therapy

PRX-00023 is unlikely to compete on the same therapeutic plain as the SSRIs

SR-58611

Efficacy in severe depression may carry over into anxiety

Initial off-label usage will support growth in GAD once approved

Gabitril (tiagabine)

Physicians unimpressed by Gabitril's efficacy in anxiety

FDA seizure warning severely threatens Gabitril's patient potential

Treatment of comorbid pain in GAD

Gabitril's 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 and BD 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 favor Seroquel SR's growth

AC-5216

Physicians are skeptical of the therapeutic potential of AC-5216

MN-305 (Osemozotan / MKC-242)

The record for the 5-HT1A partial agonists has been appallingly 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 anxiety revenues for Lundbeck and Forest

Lexapro will retain patent protection until 2011

Lexapro's anxiety specific revenues will continue to grow through 2009

Luvox CR (fluvoxamine controlled release)

Luvox will continue to grow in Japan, despite genericization

Luvox CR is commercial suicide

TGWOOAD/AA

TGWOOAD/AA's 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 FDA approval

LY686017

Risperdal (risperidone)

Risperdal demonstrates efficacy in reducing the symptoms of PTSD

J&J has limited time to gain FDA approval for Risperdal for PTSD before the availability of generic risperidone

Paxil CR (paroxetine controlled release)

GSK faces several hurdles in terms of establishing Paxil CR as a first-line treatment for PTSD

GSK's NK1 antagonists - casopitant (GW679769) and vestipitant (GW597599)

Combination of an NK1 antagonist and SSRI shows potential

Effexor XR (venlafaxine extended release)

Effexor XR's recent approval for PD will certainly boost revenues

US and EU patent expiries lead to erosion of Effexor XR revenues from 2008 onwards

YAZ (drospirenone and ethinyl estradiol)

YAZ will provide an alternative treatment to women who feel 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/Berlex's flagship women's health franchise

Librel (levonorgestrel / ethinyl estradiol)

Librel's continuous regimen may provide a competitive advantage

Librel's uptake will be limited by YAZ's first to market status

NovaDel's alprazolam oral spray

Improved therapeutic potential remains uncertain despite a head-to-head trial with alprazolam tablets

NovaDel will have difficulty in gaining FDA approval for the formulation

Datamonitor does not expect oral spray alprazolam will receive 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 well by 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

Sales calculations

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

List of Tables

Table 1: Forecast revenues ($m) of marketed and pipeline anxiety drugs across the seven major markets, 2006-15

Table 2: ICD-10 classification codes for anxiety disorders

Table 3: DSM-IV classification codes for anxiety disorders

Table 4: Prevalence rate of sub-categories of anxiety disorder 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 condition with anxiety disorders across the seven major markets

Table 10: Marketed anxiety drugs approved for specific anxiety disorders, in the US, EU and Japan.

Table 11: Percentage of total molecule volume (accounted for by anxiety, diagnosis value, 2005 (MAT Q4 2004 to Q3 2005)

Table 12: Drugs seeking approval for anxiety indications, 2006

Table 13: Drugs in Phase III development for anxiety disorders, 2006

Table 14: Drugs in Phase II development for anxiety disorders, 2006

Table 15: Drugs in Phase I development for anxiety disorders, 2006

Table 16: GSK's global CNS franchise, 2005

Table 17: GSK's marketed and pipeline anxiety drugs, 2006

Table 18: Wyeth's global CNS portfolio, 2004-05

Table 19: Wyeth's marketed and pipeline anxiety drugs, 2006

Table 20: Lilly's global CNS portfolio, 2005

Table 21: GSK's 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 from development 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 for PTSD

Table 35: Drugs approved for PMDD

Table 36: Drugs in Phase II development or above for PMDD

Table 37: Drugs approved for non-specified anxiety disorders

Table 38: Drugs in late-stage development for non-specified anxiety disorders

Table 39: Pipeline drugs recently suspended from development for non-specified anxiety disorders

Table 40: Proportion (%) of drug revenues attributed to anxiety disorders for Gabitril and approved anxiety drugs

Table 41: Estimated patient and revenue potential of YAZ in PMDD

Table 42: Estimated patient and revenue potential of Librel in PMDD

Table 43: Drugs in Phase I clinical development for anxiety disorders, 2006

Table 44: Forecast revenues ($m) of marketed and pipeline 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: Datamonitor's competitive positioning analysis of pipeline anxiety drugs compared to existing market players (1 of 2)

Table 68: Datamonitor's competitive positioning analysis of pipeline anxiety drugs compared to existing market players (2 of 2)

Table 69: Anxiety disorders market definition by ICD10 code

List of Figures

Figure 1: Datamonitor's forecast for anxiety specific revenues of pipeline and marketed anxiety drugs across the seven major markets, 2006-15

Figure 2: Datamonitor's SWOT analysis of pipeline drugs.

Figure 3: Anxiety disorders diagnostic decision tree (DSM-IV)

Figure 4: Patient distribution: acute versus chronic anxiety

Figure 5: Reasons why patients receiving antidepressant therapy are non-compliant

Figure 6: Drug classes in development for the treatment of anxiety disorders.

Figure 7: NICE measurement of cost-effectiveness of drug treatment

Figure 8: Revenues of the Paxil franchise after generic incursion

Figure 9: US Drugstore Paxil prescriptions for anxiety disorders, 2003-05

Figure 10: US revenue split of Paxil and Paxil CR between anxiety disorders and alternative indications, 2002-05

Figure 11: Forecast revenues of the Paxil franchise across the seven major markets, 2006-15

Figure 12: US revenue split of the Effexor franchise XR between anxiety disorders and alternative indications, 2002-05

Figure 13: Forecast revenues of the Wyeth's anxiety franchise across the seven major markets, 2006-15

Figure 14: US revenue split of Prozac between anxiety disorders and alternative indications, 2002-05

Figure 15: Forecast revenues of Lilly's anxiety franchise across the seven major markets, 2006-15

Figure 16: Physician rated performance of main drugs used in the treatment of anxiety disorders

Figure 17: Datamonitor's SWOT analysis of GAD pipeline drugs

Figure 18: Datamonitor's SWOT analysis of OCD pipeline drugs

Figure 19: Datamonitor's SWOT analysis of SAD pipeline drugs

Figure 20: Datamonitor's SWOT analysis of PD pipeline drugs

Figure 21: Datamonitor's SWOT analysis of PTSD pipeline drugs

Figure 22: Datamonitor's SWOT analysis of PMDD pipeline drugs

Figure 23: The pharmacologic profile of Lyrica compared to paroxetine

Figure 24: Forecast revenues of Pfizer's anxiety franchise across the seven major markets, 2006-15

Figure 25: Anxiety specific revenue forecast for Lyrica across the seven major markets, 2006-15

Figure 26: The pharmacologic profile of Cymbalta compared to paroxetine

Figure 27: Anxiety specific revenue forecast for Cymbalta across the seven major markets, 2006-15

Figure 28: The pharmacologic profile of PRX-00023 compared to paroxetine

Figure 29: Anxiety specific revenue forecast for PRX-00023 across the seven major markets, 2006-15

Figure 30: The pharmacologic profile of SR5-8611 compared to paroxetine

Figure 31: Quarterly revenues of Gabitril (2004-05)

Figure 32: The pharmacologic profile of Gabitril compared to paroxetine

Figure 33: US revenue split of Gabitril between anxiety disorders and alternative indications, 2002-05

Figure 34: The pharmacologic profile of Seroquel SR compared to paroxetine

Figure 35: US revenue split of Lexapro between anxiety disorders and alternative indications, 2002-05

Figure 36: The pharmacologic profile of Lexapro compared to paroxetine

Figure 37: US cash market share of Forest/Lundbeck's antidepressant franchise from 2002-05

Figure 38: Anxiety specific revenue forecast for Lexapro across the seven major markets, 2006-15

Figure 39: The pharmacologic profile of Luvox CR compared to paroxetine

Figure 40: The pharmacologic profile of TGWOOAD/AA compared to paroxetine

Figure 41: The pharmacologic profile of Risperdal compared to paroxetine

Figure 42: The pharmacologic profile of Paxil CR compared to paroxetine

Figure 43: Anxiety specific revenue forecast for Paxil CR across the seven major markets, 2006-15

Figure 44: The pharmacologic profile of Effexor XR compared to paroxetine

Figure 45: Anxiety specific revenue forecast for Effexor XR across the seven major markets, 2006-15

Figure 46: The pharmacologic profile of YAZ compared to paroxetine

Figure 47: Anxiety specific revenue forecast for YAZ across the seven major markets, 2006-15

Figure 48: The pharmacologic profile of Librel compared to paroxetine

Figure 49: Anxiety specific revenue forecast for Librel across the seven major markets, 2006-15

Abstract

• Detailed pipeline analysis for key products in development for GAD, SAD, OCD, PTSD, PMDD and panic disorder, plus drug sales forecasts to 2015
• Overview of patient potential segmentation by indication and unmet needs in anxiety disorders across the US, Japan, France, Germany, Italy, Spain & UK
• Benchmarking of key clinical and company attractiveness of late-phase pipeline products
• Detailed clinical trial information and opinions from key thought leaders

• Understand unmet needs in the anxiety market based on key opinion leader comments regarding both currently marketed and pipeline products
• Benchmark key late-stage anxiety compounds against current market leaders
• Assess the global sales forecasts of late-stage pipeline drugs for anxiety and examine their clinical and commercial potential

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