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Drugs of Tomorrow 2002: Depression - A pipeline driven by side effect profile

Published by: Datamonitor

Published: Apr. 4, 2002 - 188 Pages


Table of Contents






DATAMONITOR HEALTHCARE

Global Director of CNS: Susanne Begley - sbegley@datamonitor.com

Europe and Rest of World - mmeek@datamonitor.com or +44 20 7675 7311

EXECUTIVE SUMMARY

Scope

Datamonitor insight into the depression market

Lundbeck/Forest’s Lexapro is the follow up compound to Celexa with a launch

strategy to switch patients from the former to the latter. This will be the key

Lexapro’s success, although the patent expiry of rival SSRI compounds will

contribute to Lexapro reaching blockbuster status by 2009.

Duloxetine is Eli Lilly’s follow-up compound to Prozac. It is likely to be a

significant threat to Effexor, however the key to its success remains its dosage

requirements, as they must match Effexor otherwise the compound will struggle to

impact Effexor’s market position

Merck is the leading company in the development of Substance P compounds and is

set to be the first to launch into the market in 2005. However, the fortunes of

this drug will influence the actions of other competitors, because if Merck’s

drug is commercially successful then it is likely to come under early, sustained

competition from Pfizer’s CP-122721.

Key metrics

TABLE OF CONTENTS

PATIENT POTENTIAL

Introduction

Major depression

Social anxiety disorder

Generalized anxiety disorder

Panic disorder

Obsessive compulsive disorder

Post-traumatic stress disorder

Premenstrual dysphoric disorder

Future trends in the prevalence of depression

General depression prevalence in the major markets

Segmentation of depression

Diagnosis, treatment and compliance rates

Unmet needs in depression

Efficacy

Onset of action

Side effects of existing treatments

Refractory patients

Compliance

R&D APPROACH

Classification of pipeline products

Serotonergics

Noradrenergics

NK-1 Substance P antagonists

Reversible monoamine oxidase inhibitors

Novel compounds

Clinical trials endpoints in depression

Critique of clinical trial design in depression

DEPRESSION PIPELINE OVERVIEW

Late-stage pipeline

Phase III and above

Phase II

Phase I

Preclinical

Discontinued compounds

Key licensing strategies in depression

Pipeline analysis by class

Phase III and Registration

Phase II

Phase I

Preclinical

Pipeline analysis by licensing opportunity

Organon (Ariza)

Kyowa Hakko (KW-6002)

Pipeline analysis by individual company

Organon

GSK

Eli Lilly

Solvay

Pfizer

LATE-STAGE DRUG ANALYSIS

Comparison of key compounds in depression

Efficacy

Onset of action

Side effect profile

Compliance

Marketing strength

Serotonergics drug profiles

Overview

Lexapro (escitalopram)

Satisfaction of unmet needs

Ariza (gepirone)

Satisfaction of unmet needs

Sunepitron

Satisfaction of unmet needs

Robalzotan

Ectris

Satisfaction of unmet needs

Vilazodone (EMD 68843)

Satisfaction of unmet needs

Alnespirone

Satisfaction of unmet needs

DU 125530

Satisfaction of unmet needs

Comparative analysis

Noradrenergics

Overview

Duloxetine

Satisfaction of unmet needs

Substance P

Overview

Satisfaction of unmet needs

MAOIs

Overview

EmSam

Satisfaction of unmet needs

Novel compounds

Overview

Igmesine

OPC-14523

Satisfaction of unmet needs

CP-122721

KW-6002

Recently discontinued late stage development compounds

Overview

R-fluoxetine

MCI 225

NS2389

NKP 608

INNOVATIVE EARLY STAGE PROJECTS

Key phase I and preclinical compounds in depression

Ampakine

Galanin compounds

NBI 34041

CHAPTER 7 THE FUTURE DECODED

Methodology

Predicting initial market share

Forecasting future growth

Influencing factors

Market drivers

Forecast launches dates for new antidepressants

Key R&D product forecasts to 2009

Lexapro

Ariza

Duloxetine

Sunepitron

Igmesine

Substance P

DU 125530

Vilazodone

Robalzotan

ORG 12962

Leading products by 2009

Alternative scenarios

Scenario A: the launch of CP-122721

Scenario B: Paxil loses patent

CHAPTER 8 APPENDIX

Datamonitor's Central Nervous System Business Unit

Contributing experts

Table of tables

Table of figures

Bibliography

Merck KGaA, Press release, October 2000

Roper Starch Worldwide Inc. (2000) America's Mental Health Survey

Websites

R&D research methodology

Introduction

Hypothesis formulation

Hypothesis testing

Data verification and quality control

Quantification of data reliability

© Datamonitor 2002. All Rights Reserved.



Abstract

Datamonitor's Drugs of Tomorrow 2002: Depression - A Pipeline Driven by Side Effect Profile provides a comprehensive review of drugs in development for the treatment of depression. You will gain access to: • Detailed analysis of drugs in late stage development (stage II and above), including clinical and marketing profiles • Analysis of key compounds in early stage development • Revenue forecasts for key drugs up to 2009 • Alternative forecasts in the event of selected scenarios up to 2009 • The impact of new compounds and novel classes on the antidepressant market as a whole and individual brands within this market • Opinion leader comment about vital issues raised in the analysis RESEARCH METHODOLOGY: Datamonitor's Drugs of Tomorrow analyses are based on extensive secondary and primary research into compounds in development for the relevant disease. Research is conducted by an in-house team who interview over 1000 employees from approximately 600 companies to establish an extensive database of product sales figures across 26 therapeutic areas. The following steps are carried out for each Drugs of Tomorrow research project: • Key points of information on drugs in the pipeline are compiled by a research team • The pre-clinical and clinical data of the compounds is complied and analyzed • The analysis is discussed with opinion leaders and amended as appropriate • Data validation through key company contacts to validate research findings STRUCTURE AND SCOPE: Patient Potential in Depression -Examines trends in the prevalence, diagnosis and comorbidities of the disease. R&D Approach Analyzes the different classes of antidepressants in development and provides a narrative of the tools used in clinical trials and a critique of how the trials are designed. Pipeline Overview Analyzes trends in the development programs and suggests marketing strategies for compounds and licensing potential for manufacturers. Late Stage Drug Analysis Analyzes antidepressants in late stage development and provides insight into the clinical data, marketing strength and impact on the current gold standard. Early Stage Drug Analysis Analyzes promising early stage antidepressants in terms of the scientific premise of the development programs and their potential to differentiate from current and late stage antidepressants. Market Forecasts Provides revenue forecasts for key compounds in development and also alternative forecasts in the event of major impacting factors

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