Market Report Source

Overview

Introduction
Stimulated by sales of atypical antipsychotics for bipolar depression, and despite the launch of generic risperidone, the global bipolar disorder market will grow until 2011, when revenues will peak at $6.6 billion. The market will begin to decline thereafter owing to the launch of generic versions of the leading atypical antipsychotics, quetiapine, olanzapine, and ziprasidone from 2011 onwards.

Scope
Analysis of patient potential, unmet needs and clinical trial design in bipolar disorder
Overview of drugs in pre-registration, Phase III, II and I; with analysis of key companies involved in the market
Detailed profiles of key compounds in development for use in bipolar disorder, with forecasts of drug revenues to 2015
Discussion of indication expansion strategies and insight from key industry opinion leaders

Highlights
AstraZeneca will be the first company to bring an atypical antipsychotic to the bipolar depression market as a monotherapy, following demonstration of efficacy with quetiapine. Pfizer will maintain a strong schizophrenia franchise by releasing asenapine to buffer the loss in revenue due to genericization of ziprasidone.

Solvay/Wyeth/Lundbeck’s bifeprunox will be the leading market entrant in terms of bipolar disorder specific sales revenue. These companies appear to be seeking initial license for bifeprunox in the bipolar depression indication, a tactic that will both increase the commercial viability of the drug and save time/money.

Despite the commercial success of Lamictal (lamotrigine) and Depakote (valproate), the late-stage bipolar disorder pipeline only includes one anticonvulsant class molecule, Novartis’ licarbazepine.

Reasons to Purchase
Understand unmet needs in the bipolar disorder market based on key opinion leader comments
Benchmark key late-stage bipolar disorder compounds against current market leaders
Assess the global (US, Japan, five major EU) sales forecasts of late-stage pipeline drugs; 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 bipolar disorder market

Summary

Datamonitor Pipeline Assessment Summary

CHAPTER 2 PATIENT POTENTIAL

Definition of bipolar disorder

Characteristics of bipolar disorder phases

Segmentation of bipolar disorder subtypes

Bipolar I disorder

Bipolar II disorder

Bipolar III disorder (cyclothymia)

Epidemiology of bipolar disorder

Prevalence and diagnosis rate of bipolar disorder

Increased prevalence rate due to relaxing of inclusion criteria

Poor correct diagnosis rates leave room for market expansion

Unmet needs in bipolar disorder

Unmet need 1: improved maintenance therapy

Improved prophylactic treatment the key to real patient benefit

Unmet need 2: bipolar depression

Sufferers spend significantly longer in bipolar depression than mania

High suicide rate during depressive phase

Traditional antidepressants have limited efficacy

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Etiology of bipolar disorder

Neurobiology of bipolar disorder

Dopamine hypothesis of schizophrenia and bipolar mania

Monoamine theory of major depression and bipolar depression

CHAPTER 3 R&D APPROACH

Market overview

Current treatment paradigms for bipolar disorder

Treatment of manic episodes associated with bipolar disorder

Maintenance and prophylactic therapy

Treatment of bipolar depression

Sales of antipsychotics generated approximately half the revenues associated with bipolar disorder pharmacotherapy

Off-label use of antidepressants for bipolar disorder treatment

Classification of pipeline drugs seeking indication in bipolar disorder

Novel mood stabilizers

Anticonvulsants

Antipsychotics

Pharmacological development of antipsychotics

Mixed molecular targets of the current and pipeline atypical antipsychotics

Increasing concentration on side-effect profile for the antipsychotic class of therapy

Clinical trial design in bipolar disorder

Young mania rating scale

Montgomery-Åsberg Depression Rating Scale

Hamilton Rating Scale for Depression

Positive and Negative Syndrome Scale

Problems associated with bipolar disorder clinical trial design

Pipeline overview

Pipeline drugs in pre-registration

Pipeline drugs in Phase III clinical development

Pipeline drugs in Phase II clinical development

Pipeline drugs in Phase I clinical development

Lack of innovative and Phase I drugs found in the bipolar disorder pipeline

Key companies involved in the bipolar disorder pipeline

Johnson & Johnson’s bipolar disorder franchise will decline from 2008 onwards despite the launch of paliperidone

Generic incursion expected when key CNS products come off-patent

Follow-on antipsychotic may not be sufficiently differentiated

Off-label bipolar-specific sales of topiramate may deteriorate following negative trial results

RepliGen are developing a novel intracellular mood stabilizer

RG-2417 (Uridine) a potential novel mood stabilizer

Previous failure to show statistically significant efficacy of secretin in schizophrenia

Phase I trial with RG-2133-another Uridine pro-drug

CHAPTER 4 ANTIPSYCHOTIC LATE-STAGE DRUG ANALYSIS & FORECASTS

Overview of antipsychotic class of bipolar therapy

Pipeline summary

Definition of current comparator therapy

US market leader status for Seroquel despite not being licensed for maintenance therapy

Sales of atypical antipsychotics are higher for bipolar disorder than schizophrenia in the US

Short to medium-term sales unaffected by indication expansion

Experience from prescribing for schizophrenia drove the bipolar atypical antipsychotic market

Indication expansion may not be financially beneficial unless the right bipolar indication is sought

Factors required for a pipeline antipsychotic to compete in the bipolar disorder market

Market sales and forecast caveats

Seroquel for bipolar depression

Profile

Drug overview: indication expansion into bipolar depression imminent

Clinical trial data

Clinical trial data and pharmacodynamic summary

Why would an atypical antipsychotic have therapeutic efficacy against bipolar depression?

Patient potential

Marketing factors

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecasts to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Geodon for bipolar depression

Profile

Drug overview: indication expansion into bipolar depression

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

Marketing factors

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecasts to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Risperdal Consta

Profile

Drug overview: intramuscular sustained-release formulation of Risperdal

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

Significant off-label usage reduces the “new” patient population

Risperdal Consta will be competing with the oral formulations rather than IM formulations

Marketing factors

Price is primary concern but sales revenue looks strong

Increased use of risperidone might have a positive effect on Risperdal Consta sales

J&J should target its marketing of Risperdal Consta towards treating severely manic patients

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Intramuscular Abilify

Profile

Drug overview: intramuscular version of Abilify for acute intervention

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

IM version may boost sales of oral Abilify as a first-line therapy

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

Abilify’s positive side-effect profile may not be a significant advantage in the acute setting

Abilify’s lack of sedation may prove to be a disadvantage for acute mania treatment

Marketing factors

How will Abilify IM be priced?

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

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Asenapine

Profile

Drug overview: “new” atypical antipsychotic

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

Marketing factors

Pfizer bring a wealth of experience in marketing atypical antipsychotics to the table

Establishing a niche patient population for asenapine will be important for its commercial success in bipolar disorder

Delay in development may impact future sales estimates

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side-effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Bifeprunox

Profile

Drug overview: New atypical antipsychotic with similar mode of action to Abilify

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

Bifeprunox unlikely to be used for acute mania, but may have a niche in first-line maintenance therapy

Marketing factors

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

Differentiation from Abilify may become a problem

Indication in bipolar depression could boost sales and save time/money

Key events which could impact the revenue growth of bifeprunox

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

Paliperidone ER

Profile

Drug overview: metabolite of risperidone

Clinical trial data

Clinical trial data and pharmacokinetic summary

Patient potential

Development of paliperidone IM for bipolar disorder could be a better strategy

Marketing factors

Are active metabolites commercially viable?

Following Risperdal patent expiry-making the switch to paliperidone versus generic risperidone

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

Datamonitor drug assessment summary

CHAPTER 5 ANTICONVULSANT LATE-STAGE DRUG ANALYSIS & FORECASTS

Overview for anticonvulsants

Pipeline summary

Definition of current comparator therapy

Anticonvulsant ‘gold-standard’: lamotrigine

Licarbazepine

Profile

Drug overview: Metabolite of the anticonvulsant oxcarbazepine

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Unmet need 1: improved maintenance therapy

Unmet need 2: bipolar depression

Unmet need 3: treatment non-compliance

Unmet need 4: side effects

Unmet need 5: onset of therapeutic action

Forecast to 2015

Brief explanation of impacting factors

CHAPTER 6 NOVEL MOOD STABILIZER LATE-STAGE DRUG ANALYSIS & FORECAST

Overview for novel mood stabilizers

Pipeline summary

Definition of current comparator therapy

Mood stabilizer ‘gold-standard’: lithium

RG-2417 (Uridine)

Profile

Drug overview: Novel metabolism modulator

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2015

Memantine

Profile

Drug overview: NMDA receptor antagonist

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecast to 2015