Product Profiles: COPD – Novel combinations race to the finish

COPD is a growing market with a dynamic pipeline aiming to address unmet needs. A number of pipeline products threaten established drug classes. Once-daily bronchodilator combinations in particular are expected to offer a novel treatment option with high clinical and commercial potential and a number of companies are racing to be the first to reach the market.

Features and benefits

• Access Datamonitor’s independent clinical and commercial assessment of marketed brands and key pipeline agents for COPD.
• Understand what it takes to differentiate a product in COPD treatment and how the pipeline threatens current market leaders.
• Assess how pipeline products compare to each other and how they will compete with established therapies.
• Review important clinical developments for key pipeline agents with analysis of the latest clinical trial data.

Highlights

As the first once-daily LAMA, Spiriva (tiotropium; Boehringer Ingelheim) has become the clear gold-standard monotherapy for COPD, with widespread use across all disease severities. A number of novel LAMAs are being developed, but these will struggle to compete with Spiriva, which has had years to develop a loyal physician and patient base.

Significant developments are expected during 2012 as numerous promising candidates are close to reaching the COPD market. Almirall’s LAMA Eklira (aclidinium) is under review in the US and EU with a decision expected later in 2012. If successful, Eklira could pose the first direct threat to Spiriva (tiotropium; Boehringer Ingelheim).

GlaxoSmithKline and Novartis are set to go head-to-head in a number of key drug classes for COPD, including the first once-daily ICS/LABA and LABA/LAMA combinations. With Phase III trials complete and plans to file in mid-2012, GlaxoSmithKline’s Relovair (fluticasone furoate/vilanterol) is on track to become the first approved once-daily ICS/LABA.

Your key questions answered

• How do marketed treatments of COPD compare to one another and where will pipeline agents fit in?
• How are key players like Boehringer Ingelheim and GlaxoSmithKline protecting their market position in the face of increasing competition?
• Which pipeline products will need to compete with currently established treatments, and which can be positioned as add-on therapies?
• How is COPD treatment expected to change as novel therapies move through the pipeline?

Table of Contents

OVERVIEW
Catalyst
Summary

EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports

MARKET DEFINITION AND OVERVIEW
Market definition
Product overview

MARKETED PRODUCT PROFILES
Advair (fluticasone/salmeterol; GlaxoSmithKline)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Spiriva (tiotropium; Boehringer Ingelheim)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Symbicort (budesonide/formoterol; AstraZeneca)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Daliresp (roflumilast; Takeda)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Arcapta Neohaler (QAB149, indacaterol; Novartis)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Other marketed drugs for COPD
Combivent (salbutamol/ipratropium; Boehringer Ingelheim)

PIPELINE PRODUCT PROFILES
Eklira (aclidinium; Almirall)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
GSK573719/vilanterol (GlaxoSmithKline/Theravance)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial assessment
QVA149 (indacaterol/glycopyrronium bromide; Novartis)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial assessment
Olodaterol/tiotropium (Boehringer Ingelheim)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial assessment
PT003 (formoterol/glycopyrrolate; Pearl Therapeutics)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other pipeline candidates for COPD
Seebri Breezhaler (glycopyrronium bromide; Sosei/Novartis)
Vilanterol (GlaxoSmithKline)
GSK573719 (GlaxoSmithKline)
LAS40464 (aclidinium/formoterol; Almirall)
QMF149 (mometasone/indacaterol; Novartis)
BIBLIOGRAPHY
Journal papers
Websites

APPENDIX
Contributing experts
Conferences attended
Datamonitor drug assessment scorecard methodology

List of Tables

Table: Summary of the ICD-10 codes used to define COPD, 2012
Table: Key marketed and pipeline products for COPD, 2012
Table: Advair (fluticasone/salmeterol; GlaxoSmithKline) – drug profile, 2012
Table: Overview of pivotal trial data for Advair Diskus in COPD, 2012
Table: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline) for COPD, 2012
Table: Spiriva (tiotropium; Boehringer Ingelheim) – drug profile, 2012
Table: Outcomes of Spiriva’s UPLIFT trial, 2008
Table: Datamonitor's drug assessment summary of Spiriva (tiotropium; Boehringer Ingelheim) for COPD, 2012
Table: Symbicort (budesonide/formoterol; AstraZeneca) – drug profile, 2012
Table: Overview of pivotal trial data for Symbicort in COPD, 2012
Table: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for COPD, 2012
Table: Daliresp (roflumilast; Nycomed) – drug profile, 2012
Table: Pooled safety analysis of Daliresp, 2010
Table: Datamonitor's drug assessment summary of Daliresp (roflumilast; Nycomed) for COPD, 2012
Table: Arcapta (indacaterol; Novartis) – drug profile, 2012
Table: Arcapta (indacaterol): Phase III crossover study results
Table: Datamonitor's drug assessment summary of Arcapta (indacaterol; Novartis) for COPD, 2012
Table: Combivent (salbutamol/ipratropium; Boehringer Ingelheim) – drug profile, 2012
Table: Eklira (aclidinium; Almirall) – drug profile, 2012
Table: Datamonitor's drug assessment summary of Eklira (aclidinium; Almirall) for COPD, 2012
Table: Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) – drug profile, 2012
Table: Phase III asthma and COPD programs for Relovair
Table: Phase II/IIb clinical abstracts for Relovair components from the European Respiratory Society 2010 Annual Congress
Table: Fluticasone furoate: Phase IIb trial results
Table: Datamonitor's drug assessment summary of Relovair (fluticasone furoate/vilanterol) for COPD, 2012
Table: GSK573719/GSK642444 (GlaxoSmithKline) – drug profile, 2012
Table: Phase III COPD programs for GSK573719/vilanterol
Table: Datamonitor's drug assessment summary of GSK573719/vilanterol for COPD, 2012
Table: QVA149 (indacaterol/glycopyrronium bromide; Novartis) – drug profile, 2012
Table: Phase III program for QVA149 (indacaterol/glycopyrronium bromide)
Table: Datamonitor's drug assessment summary of QVA149 (indacaterol/glycopyrronium; Novartis) for COPD, 2012
Table: Olodaterol/tiotropium (Boehringer Ingelheim) – drug profile, 2012
Table: Phase III program for olodaterol/tiotropium
Table: Datamonitor's drug assessment summary of olodaterol/tiotropium (Boehringer Ingelheim) for COPD, 2012
Table: PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) – drug profile, 2012
Table: Datamonitor's drug assessment summary of PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) for COPD, 2012
Table: Seebri Breezhaler (glycopyrronium bromide; Novartis) – drug profile, 2012
Table: Vilanterol (GlaxoSmithKline) – drug profile, 2012
Table: GSK573719 (GlaxoSmithKline) – drug profile, 2012
Table: LAS40464 (aclidinium/formoterol; Almirall/Forest) – drug profile, 2012
Table: QMF149 (mometasone/indacaterol; Novartis) – drug profile, 2012
Table: Datamonitor drug assessment parameters for COPD, 2012

List of Figures

Figure: Datamonitor's drug assessment summary for COPD, 2012
Figure: Advair – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline ) for COPD, 2012
Figure: Phase IV trial comparing Spiriva with Serevent, 2011
Figure: Phase III trial comparing Spiriva Respimat with Spiriva HandiHaler
Figure: Spiriva – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Spiriva (tiotropium; Boehringer Ingelheim) for COPD, 2012
Figure: Symbicort – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for COPD, 2012
Figure: Daliresp (roflumilast): pooled results from HERMES and AURA Phase III trials
Figure: Daliresp – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Daliresp (roflumilast; Nycomed) for COPD, 2012
Figure: Arcapta (indacaterol): INVOLVE study results
Figure: Arcapta (indacaterol): INHANCE study results
Figure: Arcapta (indacaterol): INLIGHT-1 study results
Figure: Arcapta (indacaterol): INLIGHT-2 study results
Figure: Phase III INSIST trial data of indacaterol versus salmeterol
Figure: Arcapta – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Arcapta (indacaterol; Novartis) for COPD, 2012
Figure: ACCORD COPD 1: Phase III results for aclidinium
Figure: Eklira (aclidinium): results from two Phase III trials
Figure: Eklira – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Eklira (aclidinium; Almirall) for COPD, 2012
Figure: Phase II COPD trial results for Relovair
Figure: Relovair component compounds: Phase IIb summary results
Figure: Relovair – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of Relovair (fluticasone furoate/vilanterol) for COPD, 2012
Figure: Forecast launch dates for Relovair and generic fluticasone/salmeterol in the US and EU, 2011–14
Figure: GSK573719/vilanterol – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of GSK573719/vilanterol for COPD, 2012
Figure: QVA149 (indacaterol/glycopyrronium bromide): results from a Phase II trial
Figure: QVA149 – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of QVA149 (indacaterol/glycopyrronium; Novartis) for COPD, 2012
Figure: Olodaterol/tiotropium – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of olodaterol/tiotropium (Boehringer Ingelheim) for COPD, 2012
Figure: Phase IIb trial results for PT003, 2011
Figure: PT003 – SWOT analysis for COPD, 2012
Figure: Datamonitor's drug assessment summary of PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) for COPD, 2012