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Drugs of Tomorrow: Antipsychotics - Gaining Competitive Advantage From a Limited Research Base

Published by: Datamonitor

Published: Aug. 22, 2002 - 155 Pages


Table of Contents


Overview

Introduction

The antipsychotics market is currently going through a period of rapid commercial expansion. However, a new wave of products are progressing though the pipeline that focus on drug delivery and pharmacokinetics. This report analyses
the current unmet needs of the market and predicts how developmental compounds will target these needs. Complete with in depth forecasts, the report provides insight for both current players and future entrants into this commercially attractive market

Scope

A special focus on the mixed neurotransmitter receptor antagonists class: how me-too developmental drugs can differentiate from the established market

Review of innovative early phase antipsychotic products and the entry strategies to satisfy market needs

Detailed analysis of the antipsychotic pipeline and R&D strategy of numerous companies including Sanofi-Synthélabo, Novartis, Janssen and Lundbeck.

Critique of antipsychotic trial design and strategies to decease placebo response

Accompanying Pharma Market Forecast interactive model for drugs in development and major marketed antipsychotics to 2010

Reasons to Purchase

Optimize your knowledge of company strategies in the antipsychotic market

Enhance your sales forecasting ability and future product positioning through identification of market drivers

Increase your competitive intelligence by accessing drug profiles and expected product performance to 2010

Optimize your understanding of the unmet needs in the market and mechanisms to satisfy these needs

DRIVERS AND TRENDS

Efficacy is the most important unmet need in the antipsychotics pipeline, however there has been little improvement, in this clinical characteristic in recent years. Instead, antipsychotic manufacturers have been targeting side effects, and although the atypicals made great improvements in the extrapyramidal symptoms, compliance remains a major unmet need. As such, there is trend in the antipsychotics pipeline to develop long-lasting formulations, where the vast majority of these are IM depots, in order increase compliance and differentiate from the market.

PATIENT POTENTIAL

How many patients can a new antipsychotic drug target? This section provides detailed coverage of the patient potential of schizophrenia and bipolar disorder across the seven major markets. Also, in order to optimize R&D strategy, there is comprehensive analysis of the main unmet needs in the current treatment of the disease

R&D APPROACH

What kind of product is being developed for schizophrenia and bipolar disorder treatment, and what are the main endpoints required for a clinical trial? This section provides an overview of the key drug classes in development, and outlines the main clinical trial design and endpoints required to convince physicians to prescribe a new drug.

ANTIPSYCHOTIC PIPELINE OVERVIEW

Who are the major players in the antipsychotic pipeline pipeline, and at what stage of clinical development are their drugs? This chapter provides an overview of the drugs in preclinical, Phase I, II, III and above clinical trial
development. In addition, key companies in the antipsychotic pipeline are analyzed, with explanations as to why these companies stand out from the rest. Also, recommendations of key R&D strategies are given, including cases studies of companies utilizing these strategies.

LATE STAGE DRUG ANALYSIS AND FORECASTS

Which drugs will dominate the market over the next eight years? This section analyses key drugs in Phase II and above clinical development, and assesses the impact these drugs will have on the market, and how they will threaten the current mixed neurotransmitter receptor antagonists and dopamine antagonists. To do this, each drug is profiled in depth, with discussion of the strengths, weaknesses, threats and opportunities, not only of the clinical aspects of the drug but also its licensing and marketing potential. In addition, revenue forecasts to 2010 are included, utilizing Datamonitor's new interactive forecasting tool.

INNOVATIVE EARLY STAGE PROJECTS

Where is the future of antipsychotics treatment heading, and what are the most novel and exciting approaches in Phase I and preclinical development? This section selects the most innovative early stage projects, and analyzes their future market potential. Datamonitor discusses the potential of receptor specific polytherapies, as well analyzing select antipsychotic products, including Arena/Tripos’ AR116081, Solvay’s SLV-310, and ALX 5407 - developed by NPS Allelix and Janssen.

ACTION POINTS

Enhance your knowledge of key company strategies

Obtain an unbiased view of potential in-licensing opportunities

Optimize your drug forecasting and future product positioning through identification of market drivers and key players

Pinpoint key areas of the market that are not being targeted by competitors

Increase your competitive intelligence by understanding company portfolios and product performance to 2010

DATASETS

Table of tables

Table 1: Key antipsychotic market parameters, 2002-10

Table 2: Forecasts for the top five antipsychotics ($m), 2002-10.

Table 3: Range of 12-month prevalence between regions, 2002

Table 4: Patient potential in the seven major markets, 2002.

Table 5: Prevalence rates of BDI and BD II in the markets studied in this report, 2002.

Table 6: Over 18 prevalent populations for the major markets for bipolar disorders I and II, 2002.

Table 7: Trends in the prevalence (000s) of schizophrenia and BD, 2002-09.

Table 8: Overview of antipsychotics in development, 2002

Table 9: Late stage R&D pipeline antipsychotics, 2002.

Table 10: Marketed antipsychotics considered for MNR gold standard, 2002

Table 11: Scenario analysis - possible outcomes and implications for the iloperidone QTc trial.

Table 12: Global sales forecasts for iloperidone, 2002-10

Table 13: Impacting factors on the revenues of iloperidone, 2004-2010

Table 14: Global sales forecasts for blonanserin, 2002-10.

Table 15: Impacting factors on the revenues of blonanserin, 2006-2010

Table 16: Global sales forecasts for DU127090, 2006-10

Table 17: Impacting factors on the revenues of DU127090, 2006-2010

Table 18: Other MNRA compounds, 2002

Table 19: Discontinued MNRA compounds, 2002

Table 20: Global sales forecasts for MNRAs, 2002-10

Table 21: Dopamine antagonists in late stage development, 2002

Table 22: Global sales forecasts for aripiprazole, 2003-10

Table 23: Impacting factors on the revenues of aripiprazole, 2002-2010

Table 24: Global sales forecasts for dopamine antagonists, 2002-10

Table 25: Late stage antipsychotics in the Others class, 2002

Table 26: Global sales forecasts for E-5826, 2003-10

Table 27: Impacting factors on the revenues of E-5826, 2006-2010

Table 28: Other late stage MNRA, 2002

Table 29: Discontinued antipsychotic compounds, 2002

Table 30: Genes involved in the dopaminergic pathway, 2002

Table 31: Genes involved in the serotonergic pathway, 2002

Table 32: Key drugs in phase I and preclinical development for psychosis, 2002

Table 33: Confidence ratings for R&D pipeline data

Table of figures

Figure 1: Summary of antipsychotic market events, 2002-10

Figure 2: Unmet needs in treatment of psychosis, 2002

Figure 3: Epidemiology of schizophrenia in the seven major markets, 2002

Figure 4: Selected iloperidone efficacy data released by Novartis from Phase III

Figure 5: iloperidone’s satisfaction of unmet needs, 2002

Figure 6: Factors in the relative success of iloperidone, 2002

Figure 7: Blonanserin’s satisfaction of unmet need, 2002

Figure 8: Factors affecting blonanserin’s success, 2002

Figure 9: DU 127090’s satisfaction of unmet needs, 2002

Figure 10: Factors in the relative success of DU 127090, 2002

Figure 11: Satisfaction of unmet needs of late stage mixed neurotransmitter antagonists in development, 2002

Figure 12: Aripiprazole’s satisfaction of unmet needs, 2002

Figure 13: Factors in the relative success of aripiprazole, 2002

Figure 14: E-5826’s satisfaction of unmet needs, 2002

Figure 15: Factors in the relative success of E-5826, 2002

Abstract

Introduction: The antipsychotics market is entering a new era. Currently, the market is going through a period of rapid commercial expansion due to the success of the atypical mixed neuroreceptors such as Zyprexa (olanzapine) and Risperdal (risperidone). However, a new wave of antipsychotics are progressing though the pipeline that focus on drug delivery and pharmacokinetics. This analysis examines the current unmet needs of the market and predicts how developmental compounds will target these needs. Scope of this Report: * Key data and market dynamics across the seven leading markets: the US, Japan, Germany, France, Italy, Spain, and the UK * Review of innovative early phase antipsychotic products and the entry strategies to satisfy market needs * Detailed analysis of the antipsychotic pipeline and R&D strategy of numerous companies including Sanofi-Synthlabo, Novartis, Janssen and Lundbeck. * Critique of antipsychotic trial design and strategies to decease placebo response. Report Highlights: Novartis' Zomaril (iloperidone) has received much negative publicity due to its association QTc interval increase. In addition, clinical trials have shown it light on efficacy. However, a monthly IM depot will differentiate it from the market, and Novartis' vast experience of marketing Clozaril is expected to see Zomaril fight back to gain respectable revenues. BMS' Abilitat (aripiprazole) has an impressive clinical profile, and Datamonitor expects the drug enter the algorithm behind Zyprexa-pressuring Risperdal revenues. However, due to the lack of a sedative effect and IM depot formulation, the drug is not expected to be targeted at the acute schizophrenia market. Key Reasons to Buy this Report: * Optimize your knowledge of company strategies in the antipsychotic market * Enhance your sales forecasting ability and future product positioning through identification of market drivers * Increase your competitive intelligence by accessing drug profiles and forecast product performance to 2010 * Optimize your understanding of the unmet needs in the market and mechanisms to satisfy these needs

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