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氣喘標靶治療藥:關鍵意見領袖 (KOL) 考察

Targeted Therapies In Asthma: KOL Insight

出版商 FirstWord 商品編碼 351856
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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氣喘標靶治療藥:關鍵意見領袖 (KOL) 考察 Targeted Therapies In Asthma: KOL Insight
出版日期: 2016年01月01日 內容資訊: 英文




  • 抗IgE抗體
    • Xolair (omalizumab; Novartis/Roche)
  • 抗IL-5抗體
    • Nucala (mepolizumab; GlaxoSmithKline)


  • 抗IgE抗體
    • Ligelizumab (formerly QGE031; Novartis)
  • 抗IL-5抗體
    • Cinqair (reslizumab; Teva)
    • Benralizumab (formerly MEDI-563; AstraZeneca)
  • 抗IL-13抗體
    • Tralokinumab (AstraZeneca)
    • Lebrikizumab (Roche)
  • 抗IL-13/抗IL-4抗體
    • Dupilumab (anti-IL-4 receptor alpha antibody; Sanofi/Regeneron)
    • QBX258 (combination anti-IL-4 VAK694, and anti-IL-13 dectrekumab; Novartis)


  • 未完全提供治療的市場
    • 透過新藥劑、開發中藥劑、重症氣喘患者能夠減少對口服皮質類固醇的依賴、擴大治療選擇嗎?
  • 患者適格性
    • 適合抗IgE治療的患者比例較低
    • 較溫和的新產品能獲得市場佔有率嗎?
  • 患者重複
    • 複數的開發中藥物提供同樣客群相同的服務
    • 接下來是否將以作用機序、用藥法、用藥時間、次要優勢展開競爭?
  • 生物標記重複
    • 生物標記皆以同一客群為目標
    • KOL將影響治療決策、與變更藥物品牌的決定
  • 終生治療用抗體
    • 新抗體會是終生治療用嗎?
    • KOL認為疾病是否可控制、調整?
  • 併用治療
    • 部份KOL重視雙重抗體治療
    • 但預計將有來自保戶的抗議、為什麼?
  • 今後的主要臨床試驗
    • 開發中抗體尚在臨床試驗中
    • 試驗結果是否會被承認並影響市場決策?
Product Code: 596200472

Competition heating up as developers struggle to differentiate pipeline asthma antibodies

Innovative monoclonal antibodies are breathing new life into the treatment of severe asthma. But with many of them targeting similar populations and providing similar benefits, finding a competitive edge won't be easy.

Learn how key opinion leaders (KOLs) expect developers to differentiate their pipeline asthma antibodies in KOL Insight: Targeted Therapies in Asthma.

You'll hear how 12 US and European KOLs think the competitive landscape will evolve as pipeline drugs challenge mainstay treatment, Xolair, and GlaxoSmithKline's Nucala-the first new antibody to market.

View: North American KOLs, EU KOLs, marketed antibodies, pipeline antibodies

Plus: Order the report and you'll also receive three quarterly FirstWord Therapy Trends Update Bulletins absolutely free!

Answering Key Questions

Get answers to key questions about marketed and pipeline monoclonal antibodies for severe asthma:

Marketed Drugs

Anti-IgE Antibodies:

  • Xolair (omalizumab; Novartis/Roche)
      Is Xolair's market share at risk from new or pipeline antibody treatments?

Anti-IL-5 Antibodies:

  • Nucala (mepolizumab; GlaxoSmithKline)
    • Is Nucala's first to market advantage enough to protect it against competitors in the pipeline?

Pipeline Drugs

Anti-IgE Antibodies:

  • Ligelizumab (formerly QGE031; Novartis)
    • If approved, can ligelizumab increase the eligible anti-IgE patient population? By how much?

Anti-IL-5 Antibodies:

  • Cinqair (reslizumab; Teva)
    • Will Cinquair's route of administration keep it from gaining a foothold in the market?
  • Benralizumab (formerly MEDI-563; AstraZeneca)
    • Will the CALIMA and SIROCCO trials reveal which patient population is most likely to benefit from benralizumab?

Anti-IL-13 Antibodies:

  • Tralokinumab (AstraZeneca)
    • Will its biweekly dosing schedule make it harder for tralokinumab to compete with Roche's lebrikizumab?
  • Lebrikizumab (Roche)
    • How do KOLs view the results of the discontinued the LUTE and VERSE trials?

Anti-IL-13/Anti-IL-4 Antibodies:

  • Dupilumab (anti-IL-4 receptor alpha antibody; Sanofi/Regeneron)
    • How do KOLs think dupilumab will fit into the severe asthma treatment paradigm?
  • QBX258 (combination anti-IL-4 VAK694, and anti-IL-13 dectrekumab; Novartis)
    • If approved, how will QBX258 affect market share for anti-IL-13 therapies such as tralokinumab and lebrikizumab?

Top takeaways

  • Severe asthma market small but significant: Although a small percentage of the overall asthma market, severe asthma patients are an important population for drug makers. Find out why.
  • Market share for mainstay treatments: Discover whether any approved or pipeline antibodies are likely to take market share from current mainstay treatment, Xolair.
  • Potential increases in anti-IgE eligibility: Learn whether Novartis's pipeline anti-IgE, ligelizumab can increase the overall IgE eligible population.
  • Importance of first to market advantage: Find out whether any pipeline drugs will be able to catch up to Nucala, the first new antibody to be approved.
  • Overlapping target populations: Hear how KOLs think pipeline drugs targeting similar populations, and providing similar benefits, can differentiate themselves.
  • Biomarkers as differentiators: See whether novel biomarkers can be competitive differentiators for pipeline drugs, and whether drugs that don't require biomarkers will have an advantage.
  • Earlier-stage antibodies showing promise: Find out why some KOLs are excited about emerging IL-33, IL-23, and Anti-TSLP antibodies.

Key issues explored

  • An underserved market: Find out how new- and pipeline therapies are broadening treatment options for severe asthma patients, reducing dependence on oral corticosteroids.
  • Patient eligibility: A relatively low percentage of patients are eligible for Anti-IgE therapy. Can more relaxed labels help newer products win market share?
  • Patient overlap: Pipeline drugs have similar targets and offer similar benefits. Can they compete on mechanism of action, delivery method, dosing schedule, secondary benefits, etc.?
  • Biomarker overlap: The biomarkers used to identify responders all target roughly the same population. Read how KOLs think that will affect treatment decisions and brands switching.
  • Antibodies as lifelong treatments: Do new antibodies have to be lifelong treatments? Find out whether KOLs think these therapies can control and modify the disease.
  • Combination therapies: Some KOLs are excited by promising dual-antibody therapies, but anticipate challenges from payers. Find out why?
  • Key clinical trials ahead: Pipeline antibodies are still undergoing clinical trials. Find out how KOLs expect trial results to affect approval and treatment decisions.

A report based on expert knowledge

KOLs from North America

  • Gailen D Marshall. Associate professor of medicine and pathology and director of the Division of Allergy and Clinical Immunology, University of Texas-Houston Medical School, Houston, TX, USA
  • Mark FitzGerald. Director, Centre for Heart and Lung Health and Senior Scientist at the Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada
  • Daniel Jackson. Assistant professor, pediatrics, section on allergy and immunology, University of Wisconsin Hospital and Clinics, Madison, WI, USA
  • Leonard Bacharier. Professor, Pediatrics and Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine, Washington University School of Medicine, St. Louis, MO, USA
  • Carlos Camargo. Chair in Emergency Medicine, Massachusetts General Hospital (MGH), Boston, MA, USA
  • Juan Celedon. Pulmonologist and a genetic epidemiologist, Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA, USA

KOLs from Europe

  • Anonymous. Professor of Medicine and Pneumology and Head of the Departments of Pulmonary Medicine and Intensive Care Medicine, renowned University Medical Clinic, Germany
  • Fan Chung. Professor of Respiratory Medicine and Head of Experimental Studies Medicine, National Heart & Lung Institute, Imperial College London, London, UK
  • Prof David Halpin. South West Respiratory Lead, NHS England, UK
  • Anonymous. Doctor for internal medicine and pulmonology and head of pulmonary clinic at a teaching hospital.
  • Jean Bousquet. Professor of Pulmonary Medicine, University of Montpellier, Montpellier, France.
  • Dr Arnaud Bourdin. Head of the pulmonology department, Hôpital Arnaud de Villeneuve, Montpellier, France

Table of Contents(SAMPLE)

Executive summary

Research objectives

Research focus

Asthma market overview

  • Key insights summary
  • ICS/LABA combination therapies dominate the asthma treatment market
  • Effectively treating severe, refractory asthma remains the key unmet need in asthma therapy
  • Options for treating severe refractory asthma remain limited

R&D pipeline overview

Anti-lgE monoclinal antibodies (mAbs)

  • Key insights summary
  • Xolain (omalizumab, Novartis/Roche)
    • The main clinical benefit of omalizumab is reduction of exacerbations
    • A low percentage of patients are eligible for omalizumab
    • Omalizumab's dosing table restricts use, and expanding the upper lgE limit in the US could increase use
  • Ligelizumab (Novartis)
    • Ligelizumab may be value in patients who are unable to receive omalizumab due to high total lgE levels or weight
    • Ligelizumab modestly increases the eligible anti-lgE patient population

Anti-IL-5 mAbs

  • Key insights summary
    • Anti-IL-5 mAbs are all capable of reducing exacerbations on top of standard therapy
  • Nucala(mepolizumab, GlaxoSmithKline)
    • Mepoizumab reduces exacerbations by 50 percent compared to placebo
    • Mepolizumab's US label wider compared to its European label where It's only approved in adults
    • Annual treatment costs for mepolizumab are higher than Xolair which could limit uptake, particularly in Europe
    • Nucala is likely to be primarily used is in patients with blood eosinophil levels &ge300 cells/&muL
  • Cinqair (reslizumab, Teva)
    • Reslizumab reduces exacerbations by 50 percent compared to placebo
    • Reslizumab's IV route of administration is a significant commercial disadvantage
    • A subcutaneous formulation of reslizumab not expected until 2019
  • Benralizumab (AstraZeneca)
    • Phase III exacerbation trials for benralizumab are not limited to the eosinophilic phenotype

Anti-IL-13 mAbs

  • Key insights summary
    • KOLs believe that IL-13 is one of the most important targets in the management of severe asthma
  • Tralokinumab (AstraZeneca)
    • Tralokinumab most effective in patients with raised DPP-4 or periostin levels
    • Phase III exacerbations trial results for tralokinumab are expected in 2017
    • AstraZeneca's follow on anti-IL 13 mAb, MEDI-7836, may have less frequent dosing compared to tralokinumab
  • Lebrikizumab (Roche)
    • Key Phase III trials for lebrikizumab - LUTE and VERSE - halted early, but show promise
    • New Phase III trials for lebrikizumab are likely to complete in 2017

Anti-IL-13/Anti-IL-4 mAbs

  • Key insights summary
  • Dupilumab (Sanofi/Regeneron)
    • Dupilumab monotherapy effective even when controller medications are withdrawn
    • Dupilumab holds much promise as an effective treatment in patients with raised eosinophils
    • Phase III studies for dupilumab should be completed in 2017
  • QBX258 (Novrtis)
    • Dual anti-IL-13/anti-IL-4 mAb approach with QBX258 viewed favourably by KOLs

Key Early stage mAb therapies

  • Key insights summary
    • KOLs are looking forward to late-stage clinical data for the anti-IL-33 mAbs, particularly airway remodelling data
    • KOLs find anti-IL-23 mAbs appealing due to the targeting of a different type of inflammation
    • The disease modifying potential of anti-TSLP mAbs is causing great excitement amongst KOLs
    • Early stage oral therapies some way off market, but could find a niche in the treatment of severe asthma


  • Key insights summary
    • Novel mAbs are not expected to replace omalizumab
    • Anti-IL-5, anti-IL-4R and anti-IL-13 target populations overlap
    • Biomarkers identify broadly the same population
    • Mepolizumab has first to market advantage
    • Other mAbs offer promise, but biomarkers will be required
    • Mabs are considered life-long treatments
    • A single mAb will be used in clinical practice

KOL biographies

  • KOLS from North America
  • KOLS from Europe
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