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市場調查報告書
Rigel公司的過敏性鼻炎藥物R112
Rigel's Allergic Rhinitis Candidate - R112
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本報告已在2011年07月19日停止出版。
目前被現有產品所獨佔的過敏性鼻炎市場，Rigel公司的新藥物R112正受到不小的期待，處於比Mercks的Singulair（又名montelukast）更優越的地位。另外，R112也可扮演輔助藥品的角色，慢慢取代抗組織胺（antihistamine）的地位。預計2015年R112的銷售額將超過10億美元。
擅長多領域市調分析的英國專業公司 Datamonitor Corporation（總公司：倫敦），調查分析了Rigel公司的過敏性鼻炎藥物R112後，出版了一本綜合報告書 "Rigel' s Allergic Rhinitis Candidate - R112" 。
報告書內容包括：過敏性鼻炎藥物的臨床實驗、預測銷售額、研發中產品、與其他廠商的產品比較，以及與其他廠商的合作關係等等，內容綱要摘記如下：
第1章 概要
- 過敏性鼻炎
- 過敏性鼻炎的全球流行
- Rigel公司介紹
- 有關syk kinase
第2章 臨床實驗結果
- 第1、2期 2004年3月 allergen 的課題
- 第2期 2004年8月 Park Study
- 安全性
- Park Study設計
- 9 ％的意義
- Stuffiness
- Park之間的差異
- 患者人口基準
- Rigel必須考慮到廣大的季節性過敏性鼻炎患者
- FDA許可-過敏性鼻炎藥物比較容易通過
- 氣喘的徵候
第3章 與競爭廠商的比較
- 其他新藥物概要
- 主要產品的臨床實驗結果：在初期階段的臨床實驗Singulair沒有得到具統計意義的結果
- 抗組織胺藥物：以輔助藥物的姿態慢慢滲透市場
- 鼻腔內類固醇藥劑：效能不及R112，可為治療選項之一
- montelukast：短兵相接
- R112的市場滲透與預測：應有10億美元的規模
- 預測：可成為Rigel公司生產線上的一顆炸彈
第4章 R112的未來
- 第3期 臨床實驗
- R112的產品化：希望與Rigel合作的企業
- 主要與Rigel合作的企業
- Pfizer：以COPD市場為目標
- GlaxoSmithKline：銷售倚靠氣喘藥物(Advair)
- Merck & Co：以Singulair 與R112競爭
- AstraZeneca：未來有潛在合作可能
- Sanofi-Aventis：過敏藥物（Allegra）
- Schering-Plough：受到延期與通路不足的打擊
- Boehringer Ingelheim：堅守COPD市場
- UCB：在美國規模不大
附錄
Introduction
- In a therapeutic area where mature products dominate, R112 is a promising
treatment with a novel mechanism of action, likely to demonstrate clinical
superiority to Mercks Singulair (montelukast) in the treatment of allergic
rhinitis. The main drivers for R112 are use as an adjunct therapy to, and
moderate switching from the antihistamine class, resulting in forecast sales
of > $1 billion by 2015.
Scope of this report
- Assessment of Phase I/II allergen challenge and Phase II park study
trials for R112
- Forecast peak sales in 2015 based on percentage share of global
competitors sales
- Comparison with other developmental products with novel mechanisms, and
with currently marketed products
- Summary of potential partners for Rigel, including GSK, Pfizer, Merck,
AstraZeneca, Sanofi-Aventis, Schering-Plough, Boehringer Ingelheim and UCB
Research and analysis highlights
- The novel mechanism proposed by Rigels R112 has a solid scientific
rationale, and is favored by opinion leaders. However, success of an
allergic rhinitis treatment not only depends on efficacy but, as shown by
the FDA approval of Singulair (montelukast), is also highly dependent on
side effects.
- The Phase II park study trial design used by Rigel provides a real to
life assessment of the likely clinical efficacy and safety of R112. As
predicted by opinion leader research, results showed a conservative 9%
improvement over placebo in global allergy scores and did reach the primary
endpoint of the trial.
- In order to collect the required data to bring R112 to market, Rigel is
likely to partner with a large pharmaceutical company. Through portfolio,
pipeline and strategic analysis the top three contenders are AstraZeneca,
Schering-Plough and Pfizer, all of whom have global influence and experience
in the allergy market.
Key reasons to read this report
- Understand the challenges facing Rigel as they seek regulatory approval
and market penetration for R112
- Identify clinical trial design requirements and appropriate phase III
outcomes to drive physician uptake
- Assess leading respiratory company portfolios for partnership potential
ABOUT DATAMONITOR HEALTHCARE
- About the respiratory pharmaceutical analysis team
EXECUTIVE SUMMARY
- Introduction
- Scope and coverage of the brief
- Key findings about the topic
- The novel mechanism proposed by Rigels R112 has a solid scientific
rationale, and is favored by opinion leaders. However, success of an
allergic rhinitis treatment not only depends on efficacy but, as shown
by the FDA approval of Singulair (montelukast), is also highly dependent
on side effects. Although no major side effects have been found in the
clinical trials already achieved, this will be a significant hurdle for
R112 for both approval and market penetration.
- The Phase II park study trial design used by Rigel provides a real to
life assessment of the likely clinical efficacy and safety of R112. As
predicted by opinion leader research, results showed a conservative 9%
improvement over placebo in global allergy scores and did reach the
primary endpoint of the trial.
- In order to collect the required data to bring R112 to market, Rigel
is likely to partner with a large pharmaceutical company. Through
portfolio, pipeline and strategic analysis the top three contenders are
AstraZeneca, Schering-Plough and Pfizer, all of whom have global
influence and experience in the allergy market.
SECTION ONE: OVERVIEW
- Allergic rhinitis
- Unmet need in allergic rhinitis
- Reduced side effects
- Drug delivery formulation
- Greater efficacy
- Increased patient education
- Global prevalence of allergic rhinitis
- About Rigel (www.rigel.com)
- About syk kinase
SECTION TWO: CLINICAL TRIAL RESULTS
- Phase I/II allergen challenge results - March 2004
- Disappointment at initial symptom score improvement
- Phase II park study results - August 2004
- Safety
- Park study design
- What does 9% mean?
- Stuffiness
- Variations between parks
- Patient population criteria
- Rigel should focus on broad seasonal allergic rhinitis population
- FDA approval - a relatively easy task in allergic rhinitis
- Asthma indication
SECTION THREE: COMPETITION AND COMPARATORS
- Overview of other novel mechanism pipeline candidates
- NX-1510
- RBx-7796
- MCC-847
- VLA-4 integrin antagonists
- AIC
- Market leaders trial results
- Singulair did not gain statistical significance in an early allergen
challenge trial
- R112 vs. antihistamines - modest penetration, mostly used as adjunct
- R112 vs. intranasal steroids - cannot match efficacy, but another
option welcomed
- R112 vs. montelukast - head-to-head competition
- R112 market penetration and forecasts - $1 billion potential
- Expected scenario: blockbuster in Rigels pipeline
SECTION FOUR: THE FUTURE OF R112
- Phase III trials
- Commercialization of R112 - Rigel seeking partnership
- Key companies for partnership with Rigel
- Pfizer - targets the COPD market
- GlaxoSmithKline - sales dependent on Advair
- Merck & Co - Singulair is set to be R112s main competition
- AstraZeneca ( future combination potential
- Sanofi-Aventis - help for Allegra on the way?
- Schering-Plough - hurt by delays and shallow pipeline
- Boehringer Ingelheim - sticking with a COPD only strategy?
- UCB - smaller US presence
APPENDIX
- Bibliography
- Opinion Leaders
- Epidemiology
- Clinical trial data
- Research methodology
- Disclaimer
- List of Tables
- Table 1: R112 milestones
- Table 2: Global prevalence of allergic rhinitis, 2004
- Table 3: Allergen challenge study comparison and symptom scores in
subsequent trials
- Table 4: R112 potential sales
- Table 5: Comparison of key features of leading allergic rhinitis drug
clinical trials
- Table 6: Partnership opportunities for Rigel ($m)
- List of Figures
- Figure 1: R112 milestones
- Figure 2: Relationship between asthma, rhinitis and eczema
- Figure 3: Key companies with partnership potential
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