Product Profiles: Asthma/COPD - Novel combinations edge closer to market

Published by: Datamonitor

Published: Oct. 28, 2011 - 157 Pages


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
Singulair (montelukast; Merck & Co.)
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, Nycomed)
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
Dulera (mometasone/formoterol; Merck & Co.)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Other marketed drugs for asthma/COPD
Flovent (fluticasone propionate; GlaxoSmithKline)
Combivent (salbutamol/ipratropium; Boehringer Ingelheim)
Pulmicort (budesonide; AstraZeneca)
Xolair (omalizumab; Genentech)
Asmanex (mometasone; Merck & Co.)
PIPELINE PRODUCT PROFILES
Flutiform (fluticasone/formoterol; SkyePharma)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Eklira (aclidinium; Almirall)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Relovair (fluticasone furoate/GSK642444; 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
QMF149 (mometasone/indacaterol; Novartis)
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 asthma/COPD
Seebri Breezhaler (glycopyrronium bromide; Sosei/Novartis)
Vilanterol (GlaxoSmithKline)
GSK573719 (GlaxoSmithKline)
Olodaterol/tiotropium (Boehringer Ingelheim)
LAS40464 (aclidinium/formoterol; Almirall/Forest)
BIBLIOGRAPHY
Journal papers
Websites
APPENDIX
Contributing experts
Conferences attended
Datamonitor drug assessment scorecard methodology
Report methodology
TABLES
Table: Summary of the ICD-10 codes used to define asthma/COPD, 2011
Table: Key marketed and pipeline products for asthma/COPD, September 2011
Table: Advair (fluticasone/salmeterol; GlaxoSmithKline) – drug profile, 2011
Table: Overview of pivotal trial data for Advair Diskus in asthma and COPD, 2011
Table: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline) for asthma/COPD, 2011
Table: Singulair (montelukast; Merck) – drug profile, 2011
Table: Overview of pivotal trial data for Singulair in asthma, 2011
Table: Datamonitor's drug assessment summary of Singulair (montelukast; Merck) for asthma, 2011
Table: Spiriva (tiotropium; Boehringer Ingelheim) – drug profile, 2011
Table: Outcomes of Spiriva’s UPLIFT trial, 2008
Table: Datamonitor's drug assessment summary of Spiriva (tiotropium; Boehringer Ingelheim) for COPD, 2011
Table: Symbicort (budesonide/formoterol; AstraZeneca) – drug profile, 2011
Table: Overview of pivotal trial data for Symbicort in asthma and COPD, 2011
Table: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for asthma/COPD, 2011
Table: Daliresp (roflumilast; Nycomed) – drug profile, 2011
Table: Pooled safety analysis of Daliresp, 2010
Table: Datamonitor's drug assessment summary of Daliresp (roflumilast; Nycomed) for COPD, 2011
Table: Arcapta (indacaterol; Novartis) – drug profile, 2011
Table: Arcapta (indacaterol): Phase III crossover study results
Table: Datamonitor's drug assessment summary of Arcapta (indacaterol; Novartis) for COPD, 2011
Table: Dulera (mometasone/formoterol; Merck) – drug profile, 2011
Table: Datamonitor's drug assessment summary of Dulera (mometasone/formoterol) for asthma/COPD, 2011
Table: Flovent (fluticasone; GlaxoSmithKline) – drug profile, 2011
Table: Combivent (salbutamol/ipratropium; Boehringer Ingelheim) – drug profile, 2011
Table: Pulmicort (budesonide; AstraZeneca) – drug profile, 2011
Table: Xolair (omalizumab; Genentech) – drug profile, 2011
Table: Asmanex (mometasone; Merck) – drug profile, 2011
Table: Flutiform (fluticasone/formoterol; SkyePharma) – drug profile, 2011
Table: Datamonitor's drug assessment summary of Flutiform (fluticasone/formoterol) for asthma, 2011
Table: Eklira (aclidinium; Almirall) – drug profile, 2011
Table: Datamonitor's drug assessment summary of Eklira (aclidinium; Almirall) for COPD, 2011
Table: Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) – drug profile, 2011
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 asthma/COPD, 2011
Table: GSK573719/GSK642444 (GlaxoSmithKline) – drug profile, 2011
Table: Phase III COPD programs for GSK573719/vilanterol
Table: Datamonitor's drug assessment summary of GSK573719/vilanterol for COPD, 2011
Table: QVA149 (indacaterol/glycopyrronium bromide; Novartis) – drug profile, 2011
Table: Phase III program for QVA149 (indacaterol/glycopyrronium bromide)
Table: Datamonitor's drug assessment summary of QVA149 (indacaterol/glycopyrronium; Novartis) for COPD, 2011
Table: QMF149 (mometasone/indacaterol; Novartis) – drug profile, 2011
Table: Datamonitor's drug assessment summary of QMF149 (mometasone/indacaterol; Novartis) for asthma/COPD, 2011
Table: PT003 (Pearl Therapeutics) – drug profile, 2011
Table: Datamonitor's drug assessment summary of PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) for COPD, 2011
Table: Seebri Breezhaler (glycopyrronium bromide; Novartis) – drug profile, 2011
Table: Vilanterol (GlaxoSmithKline) – drug profile, 2011
Table: GSK573719 (GlaxoSmithKline) – drug profile, 2011
Table: Olodaterol/tiotropium (Boehringer Ingelheim) – drug profile, 2011
Table: LAS40464 (aclidinium/formoterol; Almirall/Forest) – drug profile, 2011
Table: Datamonitor drug assessment parameters for asthma/COPD, 2011
FIGURES
Figure: Datamonitor's drug assessment summary for asthma/COPD, 2011
Figure: Advair – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline ) for asthma/COPD, 2011
Figure: Singulair – SWOT analysis for asthma, 2011
Figure: Datamonitor's drug assessment summary of Singulair (montelukast; Merck) for asthma, 2011
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, 2011
Figure: Datamonitor's drug assessment summary of Spiriva (tiotropium; Boehringer Ingelheim) for COPD, 2011
Figure: Symbicort – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for asthma/COPD, 2011
Figure: Daliresp (roflumilast): pooled results from HERMES and AURA Phase III trials
Figure: Daliresp – SWOT analysis for COPD, 2011
Figure: Datamonitor's drug assessment summary of Daliresp (roflumilast; Nycomed) for COPD, 2011
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, 2011
Figure: Datamonitor's drug assessment summary of Arcapta (indacaterol; Novartis) for COPD, 2011
Figure: Phase III trial results for Dulera
Figure: Dulera – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of Dulera (mometasone/formoterol) for asthma/COPD, 2011
Figure: Flutiform (fluticasone/formoterol): results from FUSION I Phase III study in patients with mild to moderate asthma
Figure: Flutiform (fluticasone/formoterol): results from FUSION II Phase III study in patients with moderate to severe asthma
Figure: Flutiform – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of Flutiform (fluticasone/formoterol) for asthma, 2011
Figure: ACCORD COPD 1: Phase III results for aclidinium
Figure: Eklira (aclidinium): results from two Phase III trials
Figure: Eklira – SWOT analysis for COPD, 2011
Figure: Datamonitor's drug assessment summary of Eklira (aclidinium; Almirall) for COPD, 2011
Figure: Phase II COPD trial results for Relovair
Figure: Relovair component compounds: Phase IIb summary results
Figure: Relovair – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of Relovair (fluticasone furoate/vilanterol) for asthma/COPD, 2011
Figure: Forecast launch dates for Relovair and generic fluticasone/salmeterol in the US and EU, 2011–14
Figure: GSK573719/GSK642444 – SWOT analysis for COPD, 2011
Figure: Datamonitor's drug assessment summary of GSK573719/vilanterol for COPD, 2011
Figure: QVA149 (Indacaterol/glycopyrronium bromide): results from a Phase II trial
Figure: QVA149 – SWOT analysis for COPD, 2011
Figure: Datamonitor's drug assessment summary of QVA149 (indacaterol/glycopyrronium; Novartis) for COPD, 2011
Figure: Phase II safety study for QMF149
Figure: QMF149 – Phase II trial results
Figure: QMF149 – SWOT analysis for asthma/COPD, 2011
Figure: Datamonitor's drug assessment summary of QMF149 (mometasone/indacaterol; Novartis) for asthma/COPD, 2011
Figure: Phase IIb trial results for PT003, 2011
Figure: PT003 – SWOT analysis for COPD, 2011
Figure: Datamonitor's drug assessment summary of PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) for COPD, 2011

Abstract

Introduction

Despite a number of well-established therapies, the asthma/COPD pipeline remains highly active. A number of products have progressed in the pipeline and significant new data have been presented at this year’s respiratory conferences. Numerous product launches are expected in the next 10 years, which will fragment the markets, although a handful of companies will maintain market dominance.

Features and benefits

Access Datamonitor’s independent clinical and commercial assessment of marketed brands and key pipeline agents for asthma and COPD.
Understand to what extent current and future therapies satisfy the main clinical unmet needs in asthma and COPD.
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

GlaxoSmithKline dominates the asthma/COPD market with Advair. However, with a number of ICS/LABA combinations now available and generic Advair in development, the brand’s position is coming under threat. To counter this, GlaxoSmithKline is developing once-daily Relovair, which is on track to become the first once-daily ICS/LABA to reach the market.

Spiriva (Boehringer Ingelheim) is the clear gold-standard monotherapy for COPD, and remains the only LAMA available. Numerous LABA/LAMA combinations are moving through the pipeline, many of which are being directly compared to Spiriva in clinical trials. If approved, these products could offer improved efficacy with simplified treatment.

A number of companies are believed to be developing generic versions of Advair and Symbicort. Datamonitor believes that extensive clinical trial programs will be required to bring these to market, and that, if approved, they will launch as branded generics, offering a lower price discount than seen for less complex drugs.

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