Product Profiles: Asthma – Key industry players act to maintain dominance

• Publication date: June 2012
• Report size: 114 pages

Asthma is an established and growing industry dominated by key brands. However, competition is growing and generic threats are increasing, such that the industry will become more fragmented. A number of pipeline products, notably once-daily ICS/LABA combinations, are expected to address unmet needs and have high clinical and commercial potential.Access Datamonito...

Asthma is an established and growing industry dominated by key brands. However, competition is growing and generic threats are increasing, such that the industry will become more fragmented. A number of pipeline products, notably once-daily ICS/LABA combinations, are expected to address unmet needs and have high clinical and commercial potential.Access Datamonitor’s independent clinical and commercial assessment of industry ed brands and key pipeline agents for asthma.Understand what it takes to differentiate a product in asthma 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.Advair (GlaxoSmithKline) was the first ICS/LABA combination to launch but is expected to come under threat from generic drugs and increasing competition, but with Phase III trials complete, its follow-on Relovair is on track to become the first once-daily ICS/LABA, which, if achieved, would ensure that the industry player maintains its industry dominance.Several biologics have advanced in the pipeline. Genentech’s lebrikizumab is currently in large Phase III trials looking at exacerbations and AstraZeneca’s tralokinumab and benralizumab are both in Phase II. Biologics could address unmet needs for subsets of uncontrolled patients, but key opinion leaders maintain skepticism over their viability.Despite patent expiries for key ICS/LABA combinations, generic drugs have not yet entered any of the seven major industries. Datamonitor believes that in the next couple of years they will launch as branded generic drugs . Lower price discounts together with patients’ hesitation to switch devices will help the brands resist generic erosion.How do industry ed treatments of asthma compare to one another and where will pipeline agents fit in?How is GlaxoSmithKline protecting its industry position in the face of increasing competition and looming generic entry?How can industry players position their products at launch in order to compete in this well established industry ?How is asthma 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

•Singulair (montelukast; Merck & Co.) - 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

•Dulera (mometasone/formoterol; Merck & Co.) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Xolair (omalizumab; Genentech) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Portfolio
- Clinical and commercial attractiveness

•Other industry ed drugs for asthma - Flovent (fluticasone propionate; GlaxoSmithKline)
- Pulmicort (budesonide; AstraZeneca)
- Asmanex (mometasone; Merck & Co.)

PIPELINE PRODUCT PROFILES•Flutiform (fluticasone/formoterol; SkyePharma) - 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

•Lebrikizumab (MILR1444A; Genentech) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Clinical and commercial assessment

•Masitinib (AB-1010; AB Science) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Clinical and commercial assessment

•QMF149 (mometasone/indacaterol; Novartis) - Drug presentation
- Drug pipeline analysis
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial assessment

•Other pipeline drugs for asthma - Andolast (CR2039; Rottapharm Madaus)
- Benralizumab (MEDI-563; Kyowa Hakko Kirin/AstraZeneca)
- CYT003-QbG10 (Cytos Biotechnology)
- KB003 (anti-GM-CSF MAb; KaloBios)
- Tralokinumab (CAT-354; AstraZeneca)

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 asthma, 2012
•Table: Key industry ed and pipeline products for asthma, 2012
•Table: Advair (fluticasone/salmeterol; GlaxoSmithKline) – drug presentation, 2011
•Table: Overview of pivotal trial data for Advair in asthma, 2012
•Table: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline) for asthma, 2012
•Table: Singulair (montelukast; Merck) – drug presentation, 2011
•Table: Overview of pivotal trial data for Singulair in asthma, 2012
•Table: Datamonitor's drug assessment summary of Singulair (montelukast; Merck) for asthma, 2012
•Table: Symbicort (budesonide/formoterol; AstraZeneca) – drug presentation, 2011
•Table: Overview of pivotal trial data for Symbicort in asthma, 2012
•Table: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for asthma, 2012
•Table: Dulera (mometasone/formoterol; Merck) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of Dulera (mometasone/formoterol) for asthma, 2012
•Table: Xolair (omalizumab; Genentech) – drug presentation, 2012
•Table: Overview of pivotal trial data for Xolair in asthma, 2012
•Table: Datamonitor's drug assessment summary of Xolair (omalizumab) for asthma, 2012
•Table: Flovent (fluticasone propionate; GlaxoSmithKline) – drug presentation, 2012
•Table: Pulmicort (budesonide; AstraZeneca) – drug presentation, 2012
•Table: Asmanex (mometasone; Merck) – drug presentation, 2012
•Table: Flutiform (fluticasone/formoterol; SkyePharma) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of Flutiform (fluticasone/formoterol) for asthma, 2012
•Table: Relovair (fluticasone furoate/vilanterol; GlaxoSmithKline) – drug presentation, 2012
•Table: Phase III Relovair trials for asthma
•Table: Phase II/IIb clinical abstracts of Relovair components for asthma 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 asthma, 2012
•Table: Lebrikizumab (MILR1444A; Genentech) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of Lebrikizumab (MILR1444A; Genentech) for asthma, 2012
•Table: Masitinib (AB-1010; AB Science) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of masitinib (AB-1010; AB Science) for asthma, 2012
•Table: QMF149 (mometasone/indacaterol; Novartis) – drug presentation, 2012
•Table: Datamonitor's drug assessment summary of QMF149 (mometasone/indacaterol; Novartis) for asthma, 2012
•Table: Andolast (CR2039; Rottapharm Madaus) – drug presentation, 2012
•Table: Benralizumab (MEDI-563; AstraZeneca) – drug presentation, 2012
•Table: CYT003-QbG10 (Cytos Biotechnology) – drug presentation, 2012
•Table: KB003 (anti-GM-CSF MAb; KaloBios) – drug presentation, 2012
•Table: Tralokinumab (CAT-354; AstraZeneca) – drug presentation, 2012
•Table: Datamonitor drug assessment parameters for asthma, 2012

FIGURES•Figure: Datamonitor's drug assessment summary for asthma, 2012
•Figure: Advair – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Advair (fluticasone/salmeterol; GlaxoSmithKline ) for asthma, 2012
•Figure: Singulair – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Singulair (montelukast; Merck) for asthma, 2012
•Figure: Symbicort – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Symbicort (budesonide/formoterol; AstraZeneca) for asthma, 2012
•Figure: Phase III trial results for Dulera
•Figure: Dulera – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Dulera (mometasone/formoterol) for asthma, 2012
•Figure: Xolair – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Xolair (omalizumab) for asthma, 2012
•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, 2012
•Figure: Datamonitor's drug assessment summary of Flutiform (fluticasone/formoterol) for asthma, 2012
•Figure: Relovair component compounds: Phase IIb summary results in asthma
•Figure: Relovair – Phase III study results
•Figure: Relovair – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Relovair (fluticasone furoate/vilanterol) for asthma, 2012
•Figure: Projection launch dates for Relovair and generic fluticasone/salmeterol in the US and EU, 2011–14
•Figure: Phase II safety, tolerability, and efficacy study for lebrikizumab
•Figure: CONSORT diagram showing patient disposition and selection criteria for the trial, 2009
•Figure: MILLY Phase II study results
•Figure: Lebrikizumab – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of Lebrikizumab (MILR1444A; Genentech) for asthma, 2012
•Figure: Phase IIa safety study for AB-1010
•Figure: Masitinib – Phase IIa trial results – (A) oral corticosteroid wean (ITT population) (B) oral corticosteroid wean (subpopulation initially treated with >15mg prednisone daily/ITT population)
•Figure: Phase III efficacy and safety study for masitinib
•Figure: Masitinib – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of masitinib (AB-1010; AB Science) for asthma, 2012
•Figure: Phase II safety study for QMF149
•Figure: QMF149 – Phase II trial results
•Figure: QMF149 – SWOT analysis for asthma, 2012
•Figure: Datamonitor's drug assessment summary of QMF149 (mometasone/indacaterol; Novartis) for asthma, 2012

Companies mentioned

Bank of America Merrill Lynch, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Kewill plc, Novartis AG, Schindler Holding Ltd.