R&D Trends: Depression - Clinical attrition driven by mature market conditions

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R&D Trends: Depression – Clinical attrition driven by mature market conditions

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Several drugs have progressed through the pipeline for depression in recent years, including Pristiq (desvenlafaxine; Pfizer), Oleptro (trazodone extended release; Labopharm), and Viibryd (Forest) in the US, and Valdoxan (agomelatine; Servier/Novartis) in the EU. Despite the heightened competition within the marketplace, an abundance of drugs remain in the pipeline.Understand key dynamics in the R&D pipeline for new depression therapies Benchmark novel and existing therapies using the target product profile identified by Datamonitor Support R&D decision making by evaluating antidepressant clinical trial designs that have set a precedent Evaluate the most promising new pharmacological targets in early-stage development Access Datamonitor's prediction of how the treatment landscape may change in the next 20 years There are 46 separate programs across all stages of clinical development for depression, down from 66 in 2007 with a notably high attrition of early-stage projects. Reasons for this include promising new targets failing to yield an effective antidepressant, and big players such as GlaxoSmithKline switching its research focus.Although depleted, the early-stage pipeline still has the potential to change current treatment algorithms, which are dominated by monoamine reuptake inhibitors. Popular approaches include glutamate and neuropeptide receptor modulation. Datamonitor sees the future of treatment in depression as the specific targeting of treatment-resistant patients.Clinical trial design in depression is largely standardized. Although not required, head-to-head trials may allow for a more favorable label and explicit marketing claims. Datamonitor believes that future trials will be designed for regulatory approval in patients with treatment-resistant depression, or for use as an add-on to existing therapies.What are the key trends in the depression pipeline?What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?How will new antidepressant treatments evolve in the next 20 years?

OVERVIEW

Catalyst

Summary

EXECUTIVE SUMMARY

Strategic scoping and focus

Update details: January 2012

Datamonitor key findings

Related reports

CLINICAL PIPELINE OVERVIEW

Overview of the depression pipeline

Datamonitor has identified 46 separate programs in clinical development

Emerging features of the depression pipeline

Changes in pipeline dynamics

Companies involved in the depression pipeline

Discontinued pipeline drugs in depression

54 distinct depression projects have been discontinued since 2010

The vast majority of discontinuations happen either during preclinical testing or Phase II studies

Neuropeptide modulators and monoamine reuptake inhibitors head the list of discontinued projects

TARGET PRODUCT PROFILE

Comparator therapies

Lexapro (escitalopram; Forest/Lundbeck)

Target product profile versus current level of attainment

CLINICAL TRIAL DESIGN IN DEPRESSION

Clinical trials

Commonly used clinical trial endpoints for depression

Typical trial design

Trial length is commonly standardized to a duration of just 8 weeks

Comparator trials can provide a compelling argument for using one drug ahead of another

Future developments in clinical trial design

Treatment-resistant depression clinical trial design

Adjunctive therapy clinical trial design

INNOVATIVE EARLY-STAGE APPROACHES

Glutamate receptor modulation

NMDA receptor antagonists and partial agonists

Metabotropic glutamate receptor antagonists

Targeting neuropeptides for depression

Background

Vasopressin receptor antagonists

Neurokinin receptor antagonists

THE FUTURE OF TREATMENT IN DEPRESSION

Specific targeting of treatment-resistant patients

A label for treatment-resistant depression will bypass competition with generic first-line antidepressants

Treatment-resistant depression is characterized by a large target population and substantial unmet need

Biomarkers for depression

Considerable variations in treatment outcomes exist

Biomarkers may have utility in identifying likely responders and improving treatment outcomes

The commercial appeal of reduced R&D spend and a competitive advantage is a bonus

Biomarkers in clinical development

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX

Contributing experts

Conferences attended

Report methodology

TABLES

Table: Products in clinical development for depression, January 2012

Table: Depression clinical pipeline, by mode of action and development stage, January 2012

Table: Discontinued pipeline drugs in depression, 2010–12

Table: Discontinued drugs formerly in development for depression, by mode of action and developmental stage, 2010–12

Table: Lexapro (escitalopram; Forest/Lundbeck) – drug profile in depression, 2012

Table: Defining the gold standard for depression: key clinical trial results for Lexapro

Table: Target product profile in major depressive disorder, 2012

Table: Comparison between the HAM-D and MADRS rating scales for depression

Table: Typical Phase III clinical trial design in major depressive disorder

Table: Key facts: Lexapro (escitalopram; Forest/Lundbeck) versus Cymbalta (duloxetine; Eli Lilly) comparator trial in major depressive disorder

Table: Key facts: Symbyax (fluoxetine and olanzapine; Eli Lilly) pivotal Phase III clinical trial

Table: Key facts: Abilify (aripiprazole; Bristol-Myers Squibb/Otsuka) pivotal Phase III clinical trial

Table: Most promising innovative therapeutic approaches in depression, January 2012

FIGURES

Figure: Depression clinical pipeline, by developmental stage, January 2012

Figure: Depression clinical pipeline, by mode of action, January 2012

Figure: Products in clinical development for depression, 2007, 2011, and 2012

Figure: Modes of action in the depression pipeline, 2007, 2011, and 2012

Figure: Depression pipeline, by developmental stage and company type, January 2012

Figure: Big Pharma's involvement in the depression pipeline, January 2012

Figure: Discontinued drugs formerly in development for depression, by developmental stage, 2010–12

Figure: Modes of action of discontinued pipeline drugs and active pipeline drugs in depression, 2010–12

Figure: Head-to-head clinical trial of Lexapro (escitalopram; Forest/Lundbeck) versus Celexa (citalopram; Forest/Lundbeck)

Figure: Potential timeline for future depression therapies

Figure: Proportion of patients that display treatment-resistant depression (%) in the seven major markets, 2010

Figure: BRITE-MD study of the Antidepressant Treatment Response Index as a functional biomarker for depression

Companies mentioned

Commerzbank AG, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Johnson & Johnson, Kewill plc, Telenor ASA

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