Market Report Source

Overview

Introduction
The global anxiety disorders market is set to decline from $4.5 billion in 2006 to $2.6 billion by 2015 (CAGR 200615 -6.0%). This will be primarily due to the launch of numerous generic anxiety drugs from 2006 onwards, which will offset the revenue growth derived from existing drugs seeking additional anxiety indications, and the launch of several novel anxiety drugs.

Scope
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

Highlights
To maximize drug revenues as a final step before generic incursion, a number of existing market players are seeking approvals in additional anxiety indications. However, sales of $1.6 billion in 2006 will decline over the long-term to $1.2 billion in 2015.

Manufacturers with existing branded CNS drugs already approved for indications other than anxiety, are also seeking secondary indications in the anxiety market. Datamonitor forecasts that these drugs will enter the anxiety market from 2007 onwards, and will reach peak anxiety specific revenues of $413m in 2013.

Several novel anxiety drugs will be launched over the forecast period from 2006 onwards, including Predix’s PRX-00023 (oral non-azapirone 5-HT1A agonist) in Phase III for GAD, and Schering AG/Berlex’s YAZ (low dose drospirenone/ethinyl estradiol) and Wyeth’s Librel (low dose levonorgestrel/ethinyl estradiol), both in development for PMDD.

Reasons to Purchase
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”

Table of Contents

TABLE OF CONTENTS

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)