CNS Drug Discoveries: Schizophrenia Chapter

Schizophrenia

The antipsychotic market generated global sales of US$19.6 billion, accounting for 21% of global CNS sales in 2007. While atypical antipsychotics now account for over 80% of global sales, concerns over safety are leading to a slow down in growth.

The market is ready for the launch of the third-generation atypical antipsychotics which may offer improved tolerability and may not be associated with extrapyramidal symptoms, cardiotoxicity, weight gain or detrimental metabolic changes. Two products have recently been launched, with four in late-stage clinical development: these could be tomorrow's leading brands if they have improved tolerability and safety profiles.

Meanwhile, companies which market today's leading brands continue to optimise their drugs' life-cycles pursuing new formulations (intramuscular, slow release) to aid compliance, new indications (major depression, anxiety disorders, autism, maintenance of bipolar disorder) and to initiate additional Phase IV trials to optimise and educate the community regarding the courses of treatment.

Importantly, many of these products have been available since the 1990s and their market exclusivity is running out. All the leading brands face patent expiry (in the US) by 2014, with the first generic, risperidone, in mid-2008.

Innovation within the market has been limited, although a number of products that are in Phase II development target new pathways to treat cognitive impairment associated with schizophrenia (CIAS) through the modulation of neurokinin-3 receptor or 5-HT6 receptors.

Key schizophrenia questions answered include:

• What % of the market will be taken by generics in 2014?
• What underpins the US$1.5 billion sales estimate for J&J's Invega?
• There are 19 schizophrenia treatments in Phase II - what are they and who is developing them?
• As Lilly, J&J and AstraZeneca lose market share, which companies will emerge as players in this valuable sector?

Key products analysed and forecast

• AbilifyBristol-Myers Squibb/Otsuka
• AsenapineSchering-Plough
• BifeprunoxLundbeck/Solvay
• FanaptaVanda Pharmaceuticals
• Geodon/ZeldoxPfizer
• InvegaJohnson & Johnson
• LonasenDainippon Sumitomo Pharma
• LurisadoneDainippon Sumitomo Pharma
• RisperdalJohnson & Johnson
• SeroquelAstraZeneca
• ZyprexaEli Lilly

• Schizophrenia
  • Executive Summary
• The Facts
  • What Is Schizophrenia And Why Are We Interested In It?
    • Symptoms Associated With Schizophrenia
    • Schematic Depicting Mood Swings In Bipolar Disorder
  • Patient Statistics
    • Incidence, Diagnosis Rates And Treatment; Now And In The Future
  • Patient Model
  • Summary Of Patient Population Forecasts 2007a-2014e
• Model Assumptions

Drug Growth Drivers

Drug Growth Risks/Dampeners

The Schizophrenia Market

Global Cns Market 2007 (Us$91.9 Billion)

Global Sales Split (2006)

The Major Players

• Market Share Of Antipsychotic Players By Sales (Dec 2007a)

Players And Products In 2007

Players And Products In 2014

• Market Share Of Antipsychotic Players By Sales (Dec 2014e)

Current Treatments

Leading Brands

• Comparison Of Leading Antipsychotic Drugs

Current Products' Patent Exposure

• Patent Exposure Of Leading Antipsychotic Brands

Analysis Of Leading Brands

• Atypical Antipsychotics
• Abilify
• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Geodon/Zeldox

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Invega

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Lonasen

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Clinical Efficacy Of Blonanserin
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Risperdal

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Seroquel

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Zyprexa

• Novelty/Rationale For Mechanism Of Action
• Proof Of Concept/Clinical Data
• Management/Clinical Expertise
• Competition Within The Market-Place/Gaining Share Of Voice
• Risks Associated With Developing A Drug Within A Therapeutic Class
• Filings And Approval
• Sales Forecasts And Assumptions
• Competitor Ratio Analysis

Other Atypical Antipsychotics

• Serdolect
• Lullan
• Clozaril/Leponex
• Solian

Global Sales Forecasts Of Current Treatments 2007a - 2014e

Sales Forecasts Of Current Leading Antipsychotics

Model Assumptions

New Drugs In R&D

Drugs In Development To Treat Schizophrenia And Bipolar Disorder

Analysis Of Late-Phase Drugs

Drugs In Late-Phase Development To Treat Schizophrenia And Bipolar Disorder

D/5-Ht Receptor Antagonists

• Asenapine
  • Novelty/Rationale For Mechanism Of Action
  • Proof Of Concept/Clinical Data
  • Management/Clinical Expertise
  • Competition Within The Market-Place/Gaining Share Of Voice
  • Risks Associated With Developing A Drug Within A Therapeutic Class
  • Filings And Approval
  • Sales Forecasts And Assumptions
  • Competitor Ratio Analysis
• Bifeprunox
  • Novelty/Rationale For Mechanism Of Action
  • Proof Of Concept/Clinical Data
  • Management/Clinical Expertise
  • Competition Within The Market-Place/Gaining Share Of Voice
  • Risks Associated With Developing A Drug Within A Therapeutic Class
  • Filings And Approval
  • Sales Forecasts And Assumptions
  • Competitor Ratio Analysis
• Lurasidone
  • Novelty/Rationale For Mechanism Of Action
  • Proof Of Concept/Clinical Data
  • Management/Clinical Expertise
  • Competition Within The Market-Place/Gaining Share Of Voice
  • Risks Associated With Developing A Drug Within A Therapeutic Class
  • Filings And Approval
  • Sales Forecasts And Assumptions
  • Competitor Ratio Analysis
• Fanapta
  • Novelty/Rationale For Mechanism Of Action
  • Proof Of Concept/Clinical Data
  • Management/Clinical Expertise
  • Competition Within The Market-Place/Gaining Share Of Voice
  • Risks Associated With Developing A Drug Within A Therapeutic Class
  • Safety Profile Of Iloperidone Vs Approved Antipsychotics
  • Filings And Approval
  • Sales Forecasts And Assumptions
  • Competitor Ratio Analysis

Global Sales Forecasts Of Late-Phase Schizophrenia Drugs 2008e - 2014e

Sales Forecasts Of Late-Phase Developmental Antipsychotic Drugs

Model Assumptions

Analysis Of Phase Ii Drugs

• Bl-1020
• Cariprazine
• Evp-6124
• Mem 3454
• Ly2140023
• Vabicaserin

Competitor Ratio Analysis

• Competitor Ratio Analysis - Products
  • Cr Analysis Of Antipsychotic Agents Approved By 2014 - Based On Drug Class
• Competitor Ratio Analysis - Companies
  • Cr Analysis Of Antipsychotics Approved By 2014 - Based On Company
• Winners & Losers
• Summary Of Key Companies And Drugs In The Antipsychotic Market By 2014

Winners

Losers

Discontinuation Of Drugs

Antipsychotic Drugs Discontinued From Clinical Development

Schizophrenia Appendix 1

• Assessment Of Antipsychotic Efficacy In Schizophrenia
• Assessment Of Antipsychotic Efficacy In Bipolar Disorder

Schizophrenia Appendix 2

• Phase Transition Probability
  • Probability Of Launch

Schizophrenia Appendix 3

• Patient Model
  • Summary Of Us Schizophrenia Patient Population Forecasts
  • Summary Of European (Top 5) Schizophrenia Patient Population Forecasts
  • Summary Of Japanese Schizophrenia Patient Population Forecasts

Schizophrenia Appendix 4

• Global Antipsychotic Drug Sales 2007a-2014e

Schizophrenia Appendix 5

• Competitor Ratio Analysis Criteria
  • Key Antipsychotic Drugs On The Market By 2014

Schizophrenia Glossary

Schizophrenia References

Acronyms