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Frontier Pharma:全身性エリテマトーデス−−ファースト・イン・クラス製品の識別と商業化

Frontier Pharma: Systemic Lupus Erythematosus - Identifying and Commercializing First-in-Class Innovation

発行 GBI Research 商品コード 294434
出版日 ページ情報 英文 89 Pages
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Frontier Pharma:全身性エリテマトーデス−−ファースト・イン・クラス製品の識別と商業化 Frontier Pharma: Systemic Lupus Erythematosus - Identifying and Commercializing First-in-Class Innovation
出版日: 2013年12月31日 ページ情報: 英文 89 Pages
概要

全身性エリテマトーデスは現段階ではまだ治療法が完全には開発されておらず、またジェネリック製品も出回っていません。Benlysta(ベリムマブ)だけが米国FDA(食品医薬品局)からの認証を得ており、2012年には1億1100万米ドルの売上高を記録しました。しかし、同製品が他の開発中の製品(Rituxan(リツキシマブ)など)と比べて、突出して優れているわけではありません。そのため、関節リウマチ(RA)などの市場と比べると、今後上市される製品は既存製品との厳しい競争に晒されることはないでしょう。そして、新規製品・企業が市場を劇的に変えるものと思われます。

当レポートでは、全世界の全身性エリテマトーデス(急性播種性紅斑性狼瘡、SLE)の治療薬開発の最新動向と主要製品の情報、特にファースト・イン・クラス(画期的新薬)の詳細情報について分析し、疾患の概要や上市済み製品の特性、研究開発の進行状況、パイプライン上のファースト・イン・クラスと他製品との比較、標的分子の違い・変化、今後の研究開発・製品上市の見通しなどを調査して、その結果を概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

第3章 全身性エリテマトーデス

  • 疾患の概要
  • 疫学
  • 病態
  • 症状
  • 環境的・遺伝的傾向
  • 診断
  • 疾患の重症度の評価
    • PGA
    • SLEDAI
    • BILAG
    • SRI
  • ループス腎炎
  • 薬物療法アルゴリズム

第4章 臨床面・商業面の環境

  • コルチコステロイド
  • 抗マラリア薬
  • 細胞毒性化学療法
  • 生物製剤
    • Benlysta(ベリムマブ)
  • 従来型の治療法との長所・短所の比較
    • コルチコステロイド vs 細胞毒性療法
    • 免疫抑制剤の比較:シクロスポリン vs アザチオプリン/シクロホスファミド
    • シクロホスファミド vs アザチオプリン
    • シクロホスファミド vs ミコフェノール酸モフェチル
    • ミコフェノール酸モフェチル vs アザチオプリン
    • 生物製剤 vs 免疫抑制剤
  • 現在のアンメットニーズ

第5章 パイプライン製品開発の評価

  • 全身性エリテマトーデス向けパイプライン製品の概要
  • 標的として頻繁に利用されている分子標的群
  • パイプライン製品と上市済み製品との比較分析:治療標的群の分布状況
  • パイプライン計画の効能・安全性の比較
  • ファースト・イン・クラスと上市済み製品との比較分析
  • 既存の分子標的を対象とするパイプライン製品
  • 新規の分子標的を対象とするファースト・イン・クラス製品

第6章 ファースト・イン・クラスとパイプライン計画の評価

  • サイトカインとその受容体
    • IFN-αを標的としたパイプライン計画
    • CD74を標的としたパイプライン計画
    • B7関連タンパク質を標的としたパイプライン計画
    • IL-21を標的としたパイプライン計画
    • IL-17を標的としたパイプライン計画
    • High Mobility Protein Box 1を標的としたパイプライン計画
    • APRILを標的としたパイプライン計画
  • B細胞・T細胞の抗原
    • CD4を標的としたパイプライン計画
    • CD40Lを標的としたパイプライン計画
    • FcyR2b (CD32b)を標的としたパイプライン計画
    • CD19を標的としたパイプライン計画
    • CD22を標的としたパイプライン計画
  • 細胞内キナーゼ
    • Tyrosine Kinaseを標的としたパイプライン計画
  • その他
    • Immunoproteasome subunit 7 (IMP7)を標的としたパイプライン計画
    • ILT-7を標的としたパイプライン計画

第7章 結論

第8章 資本取引と戦略的提携

  • ライセンス契約
  • 共同開発契約
    • 共同開発契約やライセンス契約に含まれていない、ファースト・イン・クラスの開発計画

第9章 付録

図表一覧

目次
Product Code: GBIHC319MR

The Systemic Lupus Erythematosus (SLE) drug market is currently under-served by non-generic, targeted therapies. Whilst the only Food and Drug Administration (FDA)-approved biologic, Benlysta (belimumab), generated sales of $111m in 2012, there is little evidence that the drug's performance is significantly superior to other B-cell targeted therapies such as Rituxan (rituximab), which is often used off-license to treat refractory SLE patients. Therapeutics entering the market therefore do not face the staggering level of competition from currently marketed programs as in other markets such as the Rheumatoid Arthritis (RA) market. Emerging market entrants that appear to offer significant therapeutic benefits are likely to cause dramatic changes to the market landscape.

A growing understanding of the signaling pathways underlying SLE pathophysiology including, but not limited to, B cells, T cells and intracellular kinases, is translating into a higher number of novel, and more importantly, first-in-class targeted therapeutics entering the developmental pipeline. In particular, a high level of investment in the development of cytokine-blocking strategies is evident, as therapies targeting the interferon pathway are relatively common in the pipeline.

Scope

  • The report analyzes the market for SLE therapeutics and the pipeline products in that market, with particular emphasis on first-in-class programs.
  • A brief introduction to SLE, including symptoms, pathophysiology, disease scoring indices and overview of pharmacotherapy
  • In-depth analysis and literature review on marketed products, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses, based on published clinical trials, as well as a reference table of drugs in terms of safety and efficacy
  • Overview of how innovation products are contributing to the market for SLE therapeutics
  • Comprehensive review of the pipeline for first-in-class therapies, which is analyzed on the basis of phase distribution, molecule types and molecular targets, as well as administration routes
  • The changing molecular target landscape between market and pipeline, and, in particular, focal points of innovation
  • First-in-class molecular targets, highlighting early-stage programs for which clinical utility has yet to be evaluated, as well as an in-depth literature review on novel molecular targets

Reasons to buy

  • The report will assist the business development strategies of companies that wish to develop novel therapies with improved benefits to existing treatments. It will also be of interest to companies seeking to expand their pipeline portfolio through licensing agreements and co-development deals. Primarily, the report will allow clients to identify and understand market opportunities and the emerging competitive environment. It will also allow you to -
  • Understand the SLE pipeline and the factors which indicate that it is becoming more innovative
  • Understand the overall focal shifts in therapeutic molecular targets for the treatment of SLE
  • Understand the distribution of the pipeline programs by phase of development, molecule type and molecular target
  • Identify the list of first-in-class programs that are potentially open to deal-making opportunities
  • Understand the first-in-class developmental programs and gauge the current clinical effectiveness based on animal models

Abstract

Anticipation of Highly Efficacious Therapeutics Emerging from the Pipeline

The Systemic Lupus Erythematosus (SLE) market is currently under-served by targeted therapies. Whilst the only Food and Drug Administration (FDA) approved biologic, Benlysta (belimumab), generated sales of $111m in 2012, there is little evidence that the drug's performance is significantly superior to other B-cell targeted therapies such as Rituxan (rituximab), where unlicensed use is commonplace for refractory SLE patients. Therapeutics entering the market do not face the level of competition from currently marketed programs as in other markets such as the Rheumatoid Arthritis (RA) market. Emerging market entrants that appear to offer significant therapeutic benefits are likely to cause dramatic change to the market landscape.

Highly Diversified Range of Innovative Programs in the Pipeline

Although the SLE pipeline comprises only 74 active developmental programs, over 67% of these programs are biologics and around 31% involve first-in-class molecules. Only a very small number of products are repositioned from other indications and there is also a high level of diversity in terms of novel therapeutic targets. Innovative programs also target molecules that have only recently gained recognition as having therapeutic value in the treatment of SLE. However, some of these programs have only been validated in animal models and therefore require further clinical assessment in order to establish how they compete against established antibody and small molecule disease-modifying therapies. Other first-in-class programs have advanced to late-stage clinical trials.

A growing understanding of the signaling pathways underlying SLE pathophysiology including, but not limited to, B cells, T cells and intracellular kinases is being translated into a higher number of novel targeted therapeutics entering the developmental pipeline. However, a high level of sustained investment in the development of cytokine blocking strategies is present, as therapies targeting the interferon pathway are relatively common in the pipeline.

Sparse Licensing Deals and Co-development Deals Landscape

Sharing financial and developmental risks between pharmaceutical companies is a highly desirable strategy in SLE drug development, and in many cases, critical to the success of companies with limited financial resources. Although the licensing and co-development deals landscape is relatively small as an indication by industry standards, many high-profile developmental programs have been involved, particularly where licensee companies have yet to generate stable net income.

In the licensing agreement landscape, developmental drugs that inhibit intracellular kinases targeting therapies have fetched the highest valuations. It is likely that their commercial attractiveness is due to several reasons, such as their clinical efficacy in the treatment of diseases. Additionally, this could be due to the fact that kinase inhibitors are under-served in the current SLE market, which presents minimal barriers to market entry. This also appears to be the case for B and T cell targeting therapies. Interestingly, the co-development landscape is saturated with biologics, all of which target cytokines and lymphocyte antigens and many of which are first-in-class, thus indicating a high level of commercial appeal in innovative therapies.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. The Case for Innovation in Systemic Lupus Erythematosus
  • 2.2. Growing Opportunities for Biologic Products
  • 2.3. Diversification of Molecular Targets
  • 2.4. Innovative First-in-Class Product Developments Remain Attractive
  • 2.5. Changes in the Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications
  • 2.6. Sustained Innovation

3. Systemic Lupus Erythematosus

  • 3.1. Disease Overview
  • 3.2. Epidemiology
  • 3.3. Disease Pathophysiology
  • 3.4. Disease Symptoms
  • 3.5. Environmental and Genetic Predisposition
  • 3.6. Diagnosis
  • 3.7. Disease Severity Assessments
    • 3.7.1. PGA
    • 3.7.2. SLEDAI
    • 3.7.3. BILAG
    • 3.7.4. SRI
  • 3.8. Lupus Nephritis
  • 3.9. Pharmacotherapy Algorithm

4. Clinical and Commercial Landscape

  • 4.1. Corticosteroids
  • 4.2. Antimalarials
  • 4.3. Cytotoxic Chemotherapy
  • 4.4. Biologics
    • 4.4.1. Benlysta (belimumab)
  • 4.5. Comparative Strengths and Weaknesses of Traditional Therapeutics
    • 4.5.1. Corticosteroids vs Cytotoxic Therapeutics
    • 4.5.2. Comparison of Immunosuppressants: Cyclosporine vs Azathioprine or Cyclophosphamide
    • 4.5.3. Cyclophosphamide vs Azathioprine
    • 4.5.4. Cyclophosphamide vs Mycophenolate Mofetil
    • 4.5.5. Mycophenolate Mofetil vs Azathioprine
    • 4.5.6. Biologics vs Immunosuppressants
  • 4.6. Current Unmet Needs in the Systemic Lupus Erythematosus Market

5. Assessment of Pipeline Product Innovation

  • 5.1. Overview of Pipeline Products for Systemic Lupus Erythematosus
  • 5.2. Frequently Targeted Molecular Target Families
  • 5.3. Comparative Distribution of Programs between the Systemic Lupus Erythematosus Market and Pipeline by Therapeutic Target Family
  • 5.4. Comparative Efficacy and Safety of Pipeline Programs
  • 5.5. Comparative Distribution of Programs with First-in-Class and Established Targets
  • 5.6. Pipeline Programs Targeting Established Molecular Targets
  • 5.7. First-in-class Pipeline Programs with Novel Molecular Targets

6. First-in-Class Target and Pipeline Program Evaluation

  • 6.1. Cytokines and Receptors
    • 6.1.1. Pipeline Programs Targeting IFN-α
    • 6.1.2. Pipeline Programs Targeting CD74
    • 6.1.3. Pipeline Programs Targeting B7 Related Protein
    • 6.1.4. Pipeline Programs Targeting IL-21
    • 6.1.5. Pipeline Programs Targeting IL-17
    • 6.1.6. Pipeline Programs Targeting High Mobility Protein Box 1
    • 6.1.7. Pipeline Programs Targeting APRIL
  • 6.2. B and T Cell Antigens
    • 6.2.1. Pipeline Programs Targeting CD4
    • 6.2.2. Pipeline Programs Targeting CD40L
    • 6.2.3. Pipeline Programs which Target FcγR2b (CD32b)
    • 6.2.4. Pipeline Programs which Target CD19
    • 6.2.5. Pipeline Programs which Target CD22
  • 6.3. Intracellular Kinase
    • 6.3.1. Pipeline Programs which Target Spleen Tyrosine Kinase
  • 6.4. Others
    • 6.4.1. Pipeline Programs which Target Immunoproteasome subunit 7 (IMP7)
    • 6.4.2. Pipeline Programs which Target ILT-7

7. Conclusions

8. Deals and Strategic Consolidations

  • 8.1. Licensing Agreements
  • 8.2. Co-development Deals
    • 8.2.1. First-in-Class Developmental Programs Not Involved in Co-development Deals or Licensing Deals

9. Appendix

  • 9.1. References
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Contact Us
  • 9.5. Disclaimer

List of Tables

  • Table 1: SLEDAI Index
  • Table 2: Classification of Lupus Nephritis
  • Table 3: Pipeline, Global, First-in-class Modulators of B7-Related Protein, Scientific Assessment
  • Table 4: Pipeline, Global, First-in-Class Modulators of IL-17, Scientific Assessment
  • Table 5: Pipeline, Global, First-in-class Modulators of APRIL, Scientific Assessment
  • Table 6: Pipeline, Global, First-in-class Modulators of CD4, Scientific Assessment
  • Table 7: Pipeline, Global, First-in-Class Modulators of FcγR2b, Scientific Assessment
  • Table 8: Pipeline, Global, First-in-Class Modulators of CD19, Scientific Assessment
  • Table 9: Pipeline, Global, First-in-Class Modulators of CD22, Scientific Assessment
  • Table 10: Pipeline, Global, First-in-Class Modulators of Immunoproteasome Subunit 7, Scientific Assessment
  • Table 11: Pipeline, Global, First-in-Class Modulators of Immunoproteasome Subunit 7, Pipeline Development
  • Table 12: Pipeline, Global, First-in-Class Modulators of Immunoglobulin-Like Transcript 7, Pipeline Development

List of Figures

  • Figure 1: SLE, Treatment Algorithm
  • Figure 2: Systemic Lupus Erythematosus, Global, Marketed Products
  • Figure 3: Systemic Lupus Erythematosus, Global, Comparative Efficacy and Safety of Marketed Products
  • Figure 4: Systemic Lupus Erythematosus, Global, Marketed Products, Comparative Efficacy and Safety
  • Figure 5: Systemic Lupus Erythematosus, Global, Marketed Products, Comparative Efficacy and Safety
  • Figure 6: Systemic Lupus Erythematosus, Global, Marketed Products, Comparative Efficacy and Safety
  • Figure 7: Systemic Lupus Erythematosus, Global, Comparative Efficacy and Safety
  • Figure 8: Systemic Lupus Erythematosus, Global Pipeline Overview
  • Figure 9: Systemic Lupus Erythematosus, Global, Pipeline and Marketed Products
  • Figure 10: Systemic Lupus Erythematosus, Global, Comparative Efficacy and Safety of Pipeline Programs Relative to Benlysta (belimumab)
  • Figure 11: Systemic Lupus Erythematosus, Global, Pipeline, First-in-class Products
  • Figure 12: Systemic Lupus Erythematosus, Global, Pipeline, Programs with Established Molecule Targets
  • Figure 13: Systemic Lupus Erythematosus, Global, Pipeline, First-in-class Programs
  • Figure 14: Pipeline, Global, First-in-Class IFN-α Inhibitors, Scientific assessment
  • Figure 15: Pipeline, Global, First-in-Class IFN-α Inhibitors, Pipeline Development
  • Figure 16: Pipeline, Global, First-in-Class CD74 Inhibitors, Pipeline Development
  • Figure 17: Pipeline, Global, First-in-Class Modulators of B7-Related Protein, Pipeline Development
  • Figure 18: Pipeline, Global, First-in-class modulators of IL-21, Scientific Assessment
  • Figure 19: Pipeline, Global, First-in-class Modulators of IL-21, Pipeline Development
  • Figure 20: Pipeline, Global, First-in-Class Modulators of IL-17 , Pipeline Development
  • Figure 21: Pipeline, Global, First-in-Class High Mobility Box Protein 1 Inhibitors, Pipeline Development
  • Figure 22: Pipeline, Global, First-in-class Modulators of APRIL, Pipeline Development
  • Figure 23: Pipeline, Global, First-in-class Modulators of CD4, Pipeline Development
  • Figure 24: Pipeline, Global, First-in-Class Modulators of CD40L, Scientific Assessment
  • Figure 25: Pipeline, Global, First-in-Class Modulators of CD40L, Pipeline Development
  • Figure 26: Pipeline, Global, First-in-Class Modulators of FcγR2b, Pipeline Development
  • Figure 27: Pipeline, Global, First-in-Class Modulators of CD19, Pipeline Development
  • Figure 28: Pipeline, Global, First-in-Class Modulators of CD22, Pipeline Development
  • Figure 29: Pipeline, Global, First-in-Class Modulators of Spleen Tyrosine Kinase, Scientific Assessment
  • Figure 30: Pipeline, Global, First-in-Class modulators of Spleen Tyrosine Kinase, Pipeline Development
  • Figure 31: Systemic Lupus Erythematosus, Global, Licensing Agreements, 2006-2013 (October)
  • Figure 32: Systemic Lupus Erythematosus, Global, Co-development deals, 2006-2013 (October)
  • Figure 33: Systemic Lupus Erythematosus, Global, First in-Class Programs Not Involved in Co-development or Licensing Deals
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