Market Report Source

Overview

Introduction
The global schizophrenia market will continue to grow until 2010, when revenues will reach $3.8 billion. However, despite the launch of numerous pipeline schizophrenia drugs, the market will begin to decline thereafter owing to the US launch of generic risperidone in 2007, followed by generic versions of olanzapine, quetiapine and ziprasidone from 2011 onwards.

Scope
Detailed pipeline analysis for key products in development for schizophrenia, plus drug sales forecasts to 2015
Overview of patient potential, segmentation by indication and unmet needs in schizophrenia across the US, EU and Japan
Benchmarking of key product and company attractiveness of late-phase pipeline products
Detailed clinical trial information and opinions from key thought leaders

Highlights
By 2015, prospective players can expect to face stiff competition from numerous generic atypical antipsychotics. Product differentiation through improved treatment of negative or cognitive symptoms, partial responders, as well as improved tolerability, and demonstration of cost-effectiveness are essential.

Current schizophrenia drug manufacturers are taking measures to buffer the erosion of their products by generics over the forecast period. Of the current players, Datamonitor forecasts that only Pfizer will maintain a strong schizophrenia franchise after the genericization of its marketed drug, with the remaining franchises expected to decline.

The potential of Organon/Pfizer’s asenapine in treating negative symptoms will be a key therapeutic and commercial advantage, with the drug forecast to be the leading market entrant in terms of value by 2015. Lundbeck/Solvay/Wyeth’s bifeprunox’s will become the second highest new entrant in terms of value by 2015.

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

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the schizophrenia market

Key metrics

CHAPTER 2 PATIENT POTENTIAL

Etiology of schizophrenia

DSM-IV defined symptoms of schizophrenia

A – Characteristic symptoms

B – Social/occupational dysfunction

C – Duration

D – Schizoaffective and mood disorder exclusion

E – Substance/general medical condition exclusion

F – Relationship to a pervasive developmental disorder

Classification of schizophrenia

Epidemiology of schizophrenia

Schizophrenia affects 1% of the population

Comorbidities of schizophrenia

Anxiety is the most prevalent comorbidity of schizophrenia

Substance and alcohol abuse is frequently observed in schizophrenia

Depression affects a third of schizophrenia patients

Diagnosis rates of schizophrenia

Unmet needs in schizophrenia

Improving patient compliance is key

Lack of insight into schizophrenia, and the management thereof, are the most frequent reasons for patient noncompliance

Increased public and physician awareness and education

The importance of identifying a market niche before launch

Greater efficacy with fewer side-effects

A need for drugs targeting negative and cognitive symptoms, and partial-responders

Long-acting depots and patch technology are favored to improve patient compliance

CHAPTER 3 R&D APPROACH

Classification of marketed and pipeline products

Serotonergic and dopaminergic receptor antipsychotics

Dopaminergic antipsychotics

Dopamine antagonists

Dopamine agonists

Serotonergic antipsychotics

Serotonin antagonists

Serotonin agonists

Novel antipsychotics

Alpha 2 adrenoceptor antagonists

Glutamate (AMPA and NMDA) and glycine receptor modulators

Cannabinoids

Cyclooxygenase-2 inhibitors

Monoaminergic antipsychotics

Muscarinic M(1) receptor agonists

Neurokinin 3 (NK3) receptor antagonists

Nicotinic acetylcholine receptor modulators

Secretin

Clinical trials and drug development

Clinical trial endpoints and schizophrenia rating scales

Positive and Negative Syndrome Scale

Brief Psychiatric Rating Scale

Brief Assessment of Cognition in Schizophrenia

Neuropsychological Assessment Battery

Other tests

A number of other tests are used in the diagnosis and monitoring of patients during general treatment management and for the duration of clinical trials:

Clinical trial design guidance

MATRICS recommendations for the clinical trial design for cognition enhancing drugs in schizophrenia

Key research recommendations

Increased focus on cost containment

Improved quality of life

CHAPTER 4 PIPELINE DRUG ANALYSIS

Pipeline overview

Approved drugs yet to be launched

Drugs in pre-registration

Pipeline drugs in Phase III

Pipeline drugs in Phase II

Pipeline drugs in Phase I

Key companies involved in the development of novel schizophrenia therapeutics

J&J’s schizophrenia franchise will decline from 2008 onwards despite the launch of paliperidone

Lundbeck’s experience with marketing sertindole will provide a strong base from which to launch bifeprunox

Organon’s asenapine will be an exciting entrant to the schizophrenia market

Pfizer’s schizophrenia franchise will continue to grow through 2011

Dainippon-Sumitomo’s blonanserin will first launch in Japan, despite competing with the recently launched Abilify

GSK’s antipsychotic pipeline drugs are unlikely to have a significant impact on the schizophrenia market

Methodology of Datamonitor’s competitive positioning analysis

Gold standard antipsychotic

The market value is calculated using IMS diagnosis value

Forecast caveats

CHAPTER 5 LATE-STAGE PIPELINE DRUG ANALYSIS AND FORECASTS

Paliperidone

Clinical trial data

Study 1

Study 2

Study 3

Study 4

Study 5

Study 6

Completed trials

Ongoing clinical trials

Physicians not overly impressed with paliperidone therapeutic profile

Paliperidone IM – an improvement over Risperdal Consta?

Risperdal patent expiry and switch to paliperidone over generic risperidone

How will J&J price paliperidone IM compared to Risperdal Consta

Paliperidone ER will be the next entrant to the US market in H2 2006

Intramuscular Zyprexa

Clinical trial data

Ongoing clinical trials

Zyprexa’s undesirable side-effect profile will limit the uptake of the long-acting IM formulation

Intramuscular Abilify

Clinical trial data

Study 1

Study 2

Study 3

Study 4

Study 5

Completed clinical trials

Abilify IM may lead to increased use of Abilify as a first-line maintenance therapy

Abilify needs to demonstrate strong efficacy in a head-to-head study

Multiple IM doses within a 24-hour period may limit use of Abilify IM compared to other IM formulations

How will Abilify IM be priced?

BMS/Otsuka should consider a long-acting IM version of Abilify

Sertindole

Clinical trial data

Study 1

Study 2

Study 3

Study 4

Study 5

Other clinical studies

Physicians not impressed with sertindole’s tolerability despite new data

Sertindole will be the next entrant to the EU market in H2 2006

Asenapine (Org-5222)

Clinical trial data

Study 1

Study 2

Study 3

Study 4

Ongoing clinical trials

Asenapine’s potential in treating negative symptoms will be a key therapeutic and commercial advantage

Twice daily dosing of asenapine may limit uptake

Asenapine will be the leading market entrant in terms of revenue value by 2015

Bifeprunox

Clinical trial data

Study 1

Additional clinical trial data

Completed clinical trials

Ongoing clinical trials

Bifeprunox’s tolerability is a key therapeutic and commercial attribute

Bifeprunox unlikely to be used for acute psychosis, but may have a niche in first episode psychosis

Bifeprunox’s pharmacokinetic profile is suitable for once-daily dosing, with a potential for numerous reformulation strategies

Solvay and Wyeth’s experience in psychiatry and Lundbeck’s launch of sertindole will provide a strong base for the commercialization of bifeprunox

Bifeprunox will be the second-highest new entrant in terms of cash value to the schizophrenia market by 2015

Blonanserin

Clinical trial data

Study 1

Study 2

Blonanserin demonstrates no clear advantages over marketed or pipeline schizophrenia drugs

Almirall’s limited commercial presence in the EU, and lack of presence in the US will limit uptake of blonanserin outside of Japan

Blonanserin will receive its strongest uptake in the Japanese market

Seroquel SR

Clinical trial data

Ongoing clinical trials

Seroquel SR unlikely to provide significant differentiation from Seroquel

Seroquel will retain patent protection until 2011, safeguarding the initial uptake of Seroquel SR from generic quetiapine

Will US health insurers pay the increased costs for the SR formulation?

Seroquel SR is not expected to receive a strong uptake, and revenues will decline from 2012 onwards

Iloperidone

Clinical trial data

Ongoing clinical trials

If approved, QT will limit iloperidone uptake as a first-line therapy

Iloperidone offers no therapeutic advantage over marketed or pipeline schizophrenia drugs

Iloperidone will receive limited uptake in the US

CHAPTER 6 PHASE II PIPELINE DRUG ANALYSIS

Introduction

ABT-089

Clinical trial data

Nicotinic agonists which improve cognitive functioning and smoking cessation would be valuable in the management of schizophrenia

ACP-103/ACP-104

ACP-103 clinical trial data

Study 1

Study 2

Study 3

Other trial data

Ongoing clinical trials

There is little need for an adjunct to improve positive symptoms, as marketed drugs already treat this domain of schizophrenia

ACP-104 clinical trial data

Study 1

Other trial data

Ongoing clinical trials

ACP-104 would be a significant treatment advance if it can demonstrate cognitive enhancement without the side effects of clozapine

AVE-1625

Dihydrexidine

Idazoxan

Clinical trial data

Study 1

Idazoxan is unlikely to be a standalone therapy, but may have a niche in treatment-resistant schizophrenia

Lurasidone

Clinical trial data

Completed clinical trials

Ongoing clinical trials

Lurasidone – another me-too atypical, and therefore of limited therapeutic and commercial potential

LY2140023

Ocaperidone

Clinical trial data

Study 1

Other clinical trial data

J&J may choose to relicense ocaperidone from Neuro3d if ocaperidone performs well in Phase II trials

Org-24448

Org-24448 may have potential in treating cognitive functioning

RG1068

Clinical trial data

Study 1

Other clinical trial data

Ongoing clinical trials

The subcutaneous formulation is unlikely be well received by patients

Sabcomeline

773812 (SB-750093A)

Clinical trial data

Completed clinical trials

Ongoing clinical trials

SCA-136

Clinical trial data

Ongoing clinical trials

SGS518

Clinical trial data

Study 1

Study 2

Commercial and patient potential

Talnetant

Clinical trial data

Study 1

Other study data

Completed clinical trials

Ongoing clinical trials

Pharmacokinetic profile may hamper talnetant’s clinical development

CHAPTER 7 FUTURE TREATMENT OF SCHIZOPHRENIA

Future treatment of schizophrenia

APPENDIX A

Forecast revenues

Competitive positioning analysis of pipeline schizophrenia drugs

Bibliography

Websites

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: Diagnostic criteria for schizophrenia and its subtypes

Table 2: Prevalence of patients with schizophrenia exhibiting comorbid psychiatric disorders across the US, EU and Japan (%), 2005

Table 3: Risk factors for non-compliance to follow-up appointments and/or antipsychotics in patients with schizophrenia

Table 4: Potential strategies for improving compliance in patients with schizophrenia

Table 5: Novel antipsychotic drug classes in development for the treatment of schizophrenia,2006

Table 6: Approved drugs yet to be launched in the US, EU and Japan for the treatment of psychosis and schizophrenia, 2006

Table 7: Pipeline drugs in pre-registration for the treatment of psychosis and schizophrenia, 2006

Table 8: Pipeline drugs in Phase III development for psychosis and schizophrenia, 2006

Table 9: Pipeline drugs in Phase II development for psychosis and schizophrenia, 2006

Table 10: Pipeline drugs in Phase I development for psychosis and schizophrenia, 2006