Pipeline Insight: Depression - Novel drugs to grow third-line market : Market Research Report

Pipeline Insight: Depression - Novel drugs to grow third-line market

Published by: Datamonitor

Published: Mar. 22, 2007 - 206 Pages

ABOUT DATAMONITOR HEALTHCARE
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the depression market; Summary; Key metrics; Datamonitor Pipeline Assessment Summary
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS: Pipeline overview; Pipeline drugs in pre-registration and registration; Pipeline drugs in Phase III clinical development; Pipeline drugs in Phase II clinical development; Discontinued and suspended projects; CP-316311 and CP-122721; Aprepitant and L-759274; Dilopetine; MN-305; OPC-14523; Radafaxine; Key companies involved in the depression pipeline; GSK; Paxil; Wellbutrin; GSK will hope that pipeline drugs fill the gap left by Paxil's decline; Sanofi-Aventis; Key R&D company strategies; Reformulation strategies; Drug delivery reformulations; Chemical reformulation; Secondary indications; Datamonitor's gold standard MDD drug; Paxil chosen due to its frequent incorporation into clinical trial designs
CHAPTER 3 DEPRESSION - MARKET POTENTIAL: Definition of depression; DSM-IV; ICD-10; Segmentation of MDD; Elderly MDD; Child and adolescent MDD; Epidemiology of depression; MDD prevalence in the major markets; 12-month prevalence rate of 6.6% in the US; 12-month prevalence rate of 6.7% across Europe; Substantially lower prevalence rate in Japan than in the US or Europe; Age group variance in MDD prevalence rate; Diagnosis and treatment; Current classes used in depression treatment; MAOIs and TCAs-effective but side effects and safety are a concern; SSRIs retain the efficacy of MAOIs and TCAs but with more favorable side-effect and safety profiles; SNRIs have added to the treatment options, but are generally not used first-line; Treatment algorithms for MDD; Co-morbid disorders; More than half of MDD sufferers also suffer from anxiety; Unmet needs in depression; Faster onset of action; Side effects; Patient compliance; Efficacy; Efficacy may be low for first monotherapy, but improves at second-line; Efficacy similar between currently available antidepressants; Better combinations
CHAPTER 4 R&D APPROACH: Classification of pipeline products; Datamonitor's classification of pipeline products; SNRIs; Triple reuptake inhibitors; NK receptor antagonists; Serotonin receptor ligands; Other therapies; Clinical trial design in depression; Patient population; Placebo effect; Clinical trial endpoints in depression; Hamilton Rating Scale for Depression; Hamilton Rating Scale for Anxiety; Montgomery-Asberg Depression Rating Scale; Clinical Global Impression Scale; The Beck Depression Rating Scale; The Zung Self-Rating Depression Scale; Brief Psychiatric Rating Scale
CHAPTER 5 SEROTONIN NOREPINEPHRINE REUPTAKE INHIBITORS LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for SNRIs; Pipeline summary; Definition of current comparator therapy; Effexor XR (venlafaxine extended release); Desvenlafaxine (Pristiq); Profile; Drug overview: metabolite of the blockbuster Effexor 70; Clinical trial data; Efficacy and safety of Pristiq in the treatment of MDD; Randomized, double-blind, placebo-controlled study of desvenlafaxine succinate in MDD; Adverse events in the two desvenlafaxine Phase III studies; Double-blind, placebo- and moxifloxacin-controlled crossover study of the effects of desvenlafaxine succinate on QT interval in healthy adult female subjects; Ongoing clinical trials investigating the efficacy of desvenlafaxine as a treatment of MDD; Preclinical; Patient potential; Marketing factors; Satisfaction of unmet needs; Forecasts to 2016; Generic Effexor XR launch; Switching from Effexor XR to Pristiq in the estimated two years before the launch of generics; Datamonitor drug assessment summary
CHAPTER 6 TRIPLE REUPTAKE INHIBITORS (SEROTONIN/NOREPINEPHRINE/DOPAMINE) LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for triple reuptake inhibitors; Pipeline summary; Triple reuptake inhibitors are designed to inhibit the reuptake of serotonin, norepinephrine and dopamine; Studies investigating triple reuptake inhibition with two separate compounds; Definition of current comparator therapy; Effexor XR; DOV-216 303; Profile; Drug overview : DOV-216,303 has a complicated licensing history; Clinical trial data; Phase II clinical trial; Phase 1b clinical trial; Phase 1a clinical trial; Preclinical studies; Datamonitor comments; NS-2359 (GSK372475); Profile; Drug overview: triple reuptake inhibitor under development by GSK; Ongoing clinical trials; Datamonitor comments
CHAPTER 7 NK RECEPTOR ANTAGONISTS LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for NK receptor antagonists; Pipeline summary; Lack of efficacy of the NK1 receptor antagonist aprepitant in the treatment of MDD; Definition of current comparator therapy; Saredutant; Profile; Drug overview: NK2 receptor antagonist; Clinical trials data; Phase IIb clinical trial data; Preclinical data; Ongoing clinical trial program for saredutant in MDD; Patient potential; Room for an alternative mode of action in the depression market; Possible indication expansion into anxiety and pain; Marketing factors; Sanofi-Aventis has a broad experience of marketing drugs to psychiatrists; Satisfaction of unmet needs; Speed of onset of action; Side effects; Patient compliance; Better combinations; Forecasts to 2016; Saredutant could gain market share from current third-line therapies; Datamonitor drug assessment summary; Other NK receptor modulators in development; Casopitant; Vestipitant + paroxetine
CHAPTER 8 SEROTONIN RECEPTOR LIGANDS LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for serotonin receptor ligands; Pipeline summary; Definition of current comparator therapy; Gepirone ER; Profile; Drug overview: resubmission likely six years following original submission; Regulatory submissions; Clinical trial data; Relapse prevention with gepirone ER in outpatients with MDD; Retrospective subgroup analysis in patients with MDD; Sustained efficacy of gepirone-IR in MDD: a double-blind placebo substitution trial; Relapse prevention with gepirone ER in outpatients with MDD; Effect of gepirone ER on sexual function in patients with MDD; Gepirone ER in patients with anxious depression; Effects of gepirone ER on depression with anxiety symptoms: a double-blind, placebo-controlled study; Gepirone ER: new evidence for efficacy in the treatment of MDD; Phase II relapse prevention during long-term gepirone IR therapy for MDD: a double-blind substitution trial; Patient potential; Marketing factors; Satisfaction of unmet needs; Faster onset of action; Side effects; Patient compliance; Efficacy; Better combinations; Forecasts to 2016; Gepirone ER will gain market share from third-line therapies in the US and EU; Datamonitor drug assessment summary; Quetiapine (Seroquel SR); Profile; Drug overview: atypical antipsychotic; Clinical trial data; BOLDER I-A randomized, double-blind, placebo-controlled trial of Seroquel (quetiapine) in the treatment of bipolar I or II depression.; BOLDER II-Efficacy of Seroquel (quetiapine) monotherapy in bipolar depression: A confirmatory double-blind, placebo-controlled study; Ongoing clinical trial program for Seroquel SR in MDD; Current state of development; Vilazodone; Profile; Drug overview: targeting niche sub-population of MDD sufferers; Genetically guided antidepressant; Clinical trial data; Phase III program; Preclinical; Ongoing clinical trial program; Current state of development; Other Serotonin receptor ligands; Elzasonan; F-2695
CHAPTER 9 OTHER THERAPIES LATE-STAGE DRUG ANALYSIS AND FORECASTS: Overview for other therapies; Pipeline summary; Definition of current comparator therapy; Agomelatine; Profile; Drug overview: the first melatonergic antidepressant; Failed European submission by Servier; US filing by Novartis; Clinical trial data; Placebo-controlled trial of agomelatine in the treatment of MDD presented at the 13th Congress of the Association of European Psychiatrists (April 2005).; Placebo-controlled trial of agomelatine in the treatment of MDD; Absence of discontinuation symptoms with agomelatine and occurrence of discontinuation symptoms with Paxil: a randomized, double-blind, placebo-controlled discontinuation study.; Double-blind pilot study comparing the therapeutic effect of two doses of agomelatine in the treatment of MDD; Determination of the dose of agomelatine, a melatonergic agonist and selective 5-HT2C antagonist, in the treatment of MDD: a placebo-controlled dose range study.; Melatonin and agomelatine increase REM sleep and wake-up propensity without modifying NREM sleep homeostasis.; Ongoing clinical trials; Patient potential; Marketing factors; Satisfaction of unmet needs; Faster onset of action; Side effects; Patient compliance; Efficacy; Better combinations; Forecasts to 2016; Significant market share gained from hypnotics currently prescribed for depression; Datamonitor drug assessment summary; Nemifitide; Profile; Clinical trial data; Double-blind, placebo-controlled study of nemifitide in the treatment of outpatients with MDD; Phase IIc open-label extension study; Phase IIa - A double-blind, placebo-controlled, efficacy, safety, and pharmacokinetic study of nemifitide, a novel antidepressant peptide, in the treatment of major depression; Clinical pharmacokinetic studies with INN 00835 (nemifitide), a novel pentapeptide antidepressant; Preclinical; Patient potential; Marketing factors; Satisfaction of unmet needs; Faster onset of action; Side effects; Patients compliance; Efficacy; Better combinations; Forecasts to 2016; Uptake is slow and market share gain limited due to route of administration; Datamonitor drug assessment summary; Corlux (mifepristone); Profile; Drug overview: specifically targeting psychotic depression; Clinical trial data; Corcept 09; Corcept 07; Corcept 03 - Mifepristone versus placebo in the treatment of psychosis in patients with psychotic major depression; Corcept 02 - Clinical and biological effects of mifepristone treatment for psychotic depression; An eight-week open-label trial of a six-day course of mifepristone for the treatment of psychotic depression; An open-label trial of C-1073 (mifepristone) for psychotic major depression; Rapid reversal of psychotic depression using mifepristone; Ongoing clinical trial program for mifepristone in MDD; Amibegron; Profile; Drug overview: beta-3 adrenergic receptor agonist; Clinical trial data; Phase III European study in patients with a recurrent major depressive episode (EFC 5374); EFC 5379 - Non-conclusive result from North American study; Ongoing clinical trial program for amibegron in MDD; Other novel therapies in clinical development; Miraxion (LAX-101); BMS-562086; TRIDMAC; Clinical trial data; Org 24448; Org 3451Z; Ongoing clinical trials; SSR149415; Ongoing clinical trials; YKP10A; Phase II study; Phase I
CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS: Key Phase I and preclinical compounds in MDD; Key Phase I compounds in depression; TC-2216; How are NNRs and depression linked?; Preclinical and clinical development of TC-2216; SEP-225289; BIBLIOGRAPHY; Journals; Websites
APPENDIX A: Methodology; Datamonitor forecast methodology; ICD-10 codes used to define current depression market; Estimated 2006 sales revenue; MDD specific sales calculations; Product forecasts; Definition of a standard unit; Japanese market data; Datamonitor drug assessment summary; Report methodology
APPENDIX B: About Datamonitor; About Datamonitor Healthcare; Datamonitor Healthcare's therapy area capabilities; Disclaimer
List of Tables: Table 1: Datamonitor's forecast MDD revenues of key pipeline drugs and the total MDD market across the seven major markets ($m), 2008-2016; Table 2: Key pipeline drugs in registration and pre-registration for MDD in the seven major markets, 2007; Table 3: Key pipeline drugs in Phase III development for MDD in the seven major markets, 2007; Table 4: Key pipeline drugs in Phase II development for MDD, 2007; Table 5: Prevalence rate and population size for MDD across the seven major markets, 2007; Figure 6: Non-cost related unmet needs in MDD, 2007; Table 6: Key SNRI class drugs in the late-stage MDD R&D pipeline, 2007; Table 7: Estimated key events, approvals and launch dates impacting Pristiq's revenue forecast, 2006-2016; Table 8: Key triple reuptake inhibitor class drugs in the late-stage MDD R&D pipeline, 2007; Table 9: Key NK receptor antagonist class drugs in the late-stage MDD R&D pipeline, 2007; Table 10: Estimated key events, approvals and launch dates impacting saredutant's revenue forecast, 2006-2016; Table 11: Key serotonin receptor ligands class drugs in the late-stage MDD R&D pipeline, 2007; Table 12: Estimated key events, approvals and launch dates impacting gepirone ER's revenue forecast, 2006-2016; Table 13: Key other therapies class drugs in the late-stage MDD R&D pipeline, 2007; Table 14: Estimated key events, approvals and launch dates impacting agomelatine's revenue forecast, 2006-2016; Table 15: Estimated key events, approvals and launch dates impacting nemifitide's revenue forecast, 2006-2016; Table 16: Key pipeline drugs in Phase I development for MDD, 2007; Table 17: Key pipeline drugs in preclinical development for MDD, 2007; Table 18: Possible roles of neuronal nicotinic receptors; Table 19: ICD-10 and DSM-IV codes for MDD
List of Figures: Figure 1: Datamonitor's MDD drug assessment summary; Figure 2: Drugs in development at each stage of development for MDD, 2007; Figure 3: $1.8 billion decrease in GSK's global depression portfolio between 2003 and 2006.; Figure 4: Company reported, all-indication global sales revenue for Prozac, 2000-05; Figure 5: STAR*D treatment algorithm for depression; Figure 7: Effexor (venlafaxine) versus SSRIs; Figure 8: Datamonitor's forecast of MDD specific sales for Pristiq across the seven major markets ($m), 2006-2016; Figure 9: Datamonitor's competitive positioning analysis for Pristiq in MDD; Figure 10: Datamonitor's forecast of MDD specific sales for saredutant across the seven major markets ($m), 2006-2016; Figure 11: Datamonitor's competitive positioning analysis for saredutant in MDD; Figure 12: Datamonitor's forecast of MDD specific sales for gepirone ER across the seven major markets ($m), 2006-2016; Figure 13: Datamonitor's competitive positioning analysis for gepirone in MDD; Figure 14: Dose adjustment of Seroquel for different indications.; Figure 15: Datamonitor's forecast of MDD specific sales for agomelatine across the seven major markets ($m), 2006-2016; Figure 16: Datamonitor's competitive positioning analysis for agomelatine in MDD; Figure 17: Datamonitor's forecast of MDD specific sales for nemifitide across the seven major markets ($m), 2006-2016; Figure 18: Datamonitor's competitive positioning analysis for nemifitide in MDD; Figure 19: Clinical trial path for amibegron MDD trial (EFC5374)

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Pipeline Insight: Depression - Novel drugs to grow third-line market

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Abstract