Drug and Medication Industry: Product Profiles: COPD – Novel combinations race to the finish

• Publication date: May 2012
• Report size: 129 pages

COPD is a growing industry 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 industry players are racing to be the first to reach the industry ....

COPD is a growing industry 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 industry players are racing to be the first to reach the industry .Access Datamonitor’s independent clinical and commercial assessment of industry ed brands and key pipeline agents for COPD.Understand what it takes to differentiate a product in COPD treatment and how the pipeline threatens current industry 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.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 industry . 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.How do industry ed treatments of COPD compare to one another and where will pipeline agents fit in?How are major competitors like Boehringer Ingelheim and GlaxoSmithKline protecting their industry 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?

Drug And Medication Industry

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 presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Spiriva (tiotropium; Boehringer Ingelheim) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Symbicort (budesonide/formoterol; AstraZeneca) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Daliresp (roflumilast; Takeda) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Arcapta Neohaler (QAB149, indacaterol; Novartis) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Other industry ed drugs for COPD - Combivent (salbutamol/ipratropium; Boehringer Ingelheim)

PIPELINE PRODUCT PROFILES•Eklira (aclidinium; Almirall) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

•GSK573719/vilanterol (GlaxoSmithKline/Theravance) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial assessment

•QVA149 (indacaterol/glycopyrronium bromide; Novartis) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial assessment

•Olodaterol/tiotropium (Boehringer Ingelheim) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial assessment

•PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) - Drug presentation
- Drug pipeline analysis
- 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

TABLES•Table: Summary of the ICD-10 codes used to define COPD, 2012
•Table: Key industry ed and pipeline products for COPD, 2012
•Table: Advair (fluticasone/salmeterol; GlaxoSmithKline) – drug presentation, 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 presentation, 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 presentation, 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 presentation, 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 presentation, 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 presentation, 2012
•Table: Eklira (aclidinium; Almirall) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of Eklira (aclidinium; Almirall) for COPD, 2012
•Table: Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) – drug presentation, 2012
•Table: Phase III asthma and COPD programs for Relovair
•Table: Phase II/IIb clinical abstracts for Relovair components from the EUR pean 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 presentation, 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 presentation, 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 presentation, 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 presentation, 2012
•Table: Datamonitor's drug assessment summary of PT003 (formoterol/glycopyrrolate; Pearl Therapeutics) for COPD, 2012
•Table: Seebri Breezhaler (glycopyrronium bromide; Novartis) – drug presentation, 2012
•Table: Vilanterol (GlaxoSmithKline) – drug presentation, 2012
•Table: GSK573719 (GlaxoSmithKline) – drug presentation, 2012
•Table: LAS40464 (aclidinium/formoterol; Almirall/Forest) – drug presentation, 2012
•Table: QMF149 (mometasone/indacaterol; Novartis) – drug presentation, 2012
•Table: Datamonitor drug assessment parameters for COPD, 2012

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: Projection 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

Companies mentioned

First Data Corporation, first direct, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Novartis AG, Schindler Holding Ltd.