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Frontier Pharma:乾癬─劃時代醫藥品改革的識別與商品化

Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation

出版商 GBI Research 商品編碼 307594
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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Frontier Pharma:乾癬─劃時代醫藥品改革的識別與商品化 Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation
出版日期: 2014年05月30日 內容資訊: 英文





第1章 目次

第2章 技術革新的範例

  • 生物製藥產品的市場機會擴增
  • 分子標的的多樣化
  • 創新的劃時代產品開發:現在也依然是饒富魅力的領域
  • 臨床與商業環境的變化:將會與以病患人口數與利基症狀為標的的藥物靠攏
  • 乾癬相關的創新

第3章 臨床與商業環境

  • 疾病概要
  • 流行病學
  • 病因
    • 遺傳因素
    • 環境因素
  • 病理學
    • 角質細胞
    • 樹狀細胞
    • T細胞
    • 血管生成
    • 生長因子
  • 症狀、併發症
    • 皮膚症狀
    • 乾癬性關節炎
    • 心血管疾病
    • 心理影響
  • 乾癬的診斷
    • 乾癬性關節炎的診斷
  • 治療方法
    • 藥物治療
    • 局部藥劑治療
    • 全身性藥劑治療
    • 非藥物治療
    • 併用、循環療法
  • 已上市的乾癬用產品概要
    • 口服非生物製藥DMARD
    • 標示外使用之DMARD
    • 生物製藥
    • 已上市產品的效能與安全性比較
    • 未滿足需求

第4章 開發中產品的評價與創新

  • 概要
  • 開發計畫的效能與安全性比較
  • 乾癬用已上市/開發中產品的分佈比較:以治療標的族群分類
  • 劃時代醫藥品/現存分子標的的分佈比較
  • 以現存分子標的為對象的開發中產品
  • 以新發現之分子標的為對象,劃時代醫藥品的開發中產品

第5章 劃時代醫藥品的標的與開發中產品的評價

  • 細胞激素及其受器
    • 腫瘤壞死因子(TNF)受器標靶藥物開發計畫
    • 第六型介白素(IL6)標靶藥物開發計畫
    • 第八型介白素(IL8)標靶藥物開發計畫
    • 第17型介白素(IL17)標靶藥物開發計畫
    • γ型介白素(ILγ)標靶藥物開發計畫
  • B細胞/T細胞的抗原
    • CD4標靶藥物開發計畫
    • CD28標靶藥物開發計畫
  • 胞內激□
    • 第1型介白素受體相關激□4(interleukin 1 receptor-associated kinase4, IRAK-4)標靶藥物開發計畫
  • 核受體
    • 維他命A酸受器相關孤兒受器標靶藥物開發計畫
  • 生長因子
    • TGF-β受器標靶藥物開發計畫
    • IRS-1受器標靶藥物開發計畫
  • 離子通道
    • 鈣離子釋放機活鈣離子通道(Calcium Release-Activated Calcium Channel)標靶藥物開發計畫
  • 整合素
    • 血管附著蛋白-1標靶藥物開發計畫
  • 其他
    • F1F0 ATP合成□標靶藥物開發計畫
    • 半胱胺酸蛋白質酵素S(Cathepsin S, CTSS標靶藥物開發計畫
  • 結論

第6章 資本交易與策略性合併

  • 執照合約
  • 主要共同開發合約
  • 劃時代醫藥品開發不包含在共同開發或執照契約之中

第7章 附錄


Product Code: GBIHC330MR

GBI Research has released the pharma report: "Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation", which identifies and assesses first-in-class innovation in the psoriasis development pipeline.

Over the last decade, a greater understanding of the underlying pathophysiology of psoriasis has increased emphasis on developing immuneomodulating therapies, as opposed to largely symptomatic treatments. This is currently reflected in a competitive market dominated by multiple disease-modifying biologic therapies (inhibitors of TNF-a and IL-12/IL-23) and generic small-molecule therapies. Despite this, there are significant unmet needs in the market, including safety concerns regarding immunomodulation. This is a particularly important issue for the long-term commercial and clinical success of psoriatic therapeutics, especially for emerging biologics. Another unmet need is ease of drug application, as biologic drug delivery is invasive and painful.

This allows for pipeline programs that offer a more refined approach to immunomodulation and ease of drug application to gain market share upon entry. In a pipeline of over 200 programs, approximately one third exhibits a novel mechanism of action. Innovative programs target a wide range of molecules implicated in immune signaling, such as cytokines and B and T cell antigens. Several promising first-in-class therapies can selectively modulate specific subsets of immune cells without compromising the entire immune system. In particular, biologics that target a subset of T cells, which are strongly implicated in autoimmune pathophysiology, could allow for specificity of immune suppression and thereby reduce adverse side effects. Based on clinical trials, IL-17-targeted therapies have demonstrated superiority over currently established therapies in achieving advanced clinical endpoints. Other agents which activate regulatory arms of the immune system have also shown promising clinical profiles. In addition, innovative programs that target molecules have only recently gained recognition of their therapeutic value in the treatment of psoriasis, including novel angiogenic proteins, signaling transduction proteins and novel nuclear receptors. Despite their recent implication in disease pathophysiology, many of these agents have also demonstrated clinical utility in the treatment of psoriasis and are likely to contribute to a diversified therapeutic landscape.


  • A brief introduction to psoriasis, including symptoms, pathophysiology, and overview of pharmacotherapy
  • The changing molecular target landscape between market and pipeline and particular focal points of innovation
  • Overview of how innovative products are contributing to the pipeline and market for psoriasis
  • Comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of phase distribution, molecule type, molecular target, and administration route
  • Identification and assessment of first-in-class molecular targets with a particular focus on early-stage programs of which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets
  • Assessment of the licensing and co-development deals for psoriasis therapies

Reasons to buy

  • Understanding of the focal shifts in molecular targets in the psoriasis pipeline
  • Understanding of the distribution of pipeline programs by phase of development, molecule type and molecular target
  • Scientific and clinical analysis of first-in-class developmental programs
  • Assessment of the valuations of licensed and co-developed psoriasis treatments
  • A list of the first-in-class therapies potentially open to deal-making opportunities.
  • Analysis of financial valuations on licensed or co-developed first-in-class therapies and generics


Despite mostly targeting established molecules, the psoriasis pipeline is showing a high level of innovation in first-in-class molecules, including novel angiogenic drugs, growth factors, chaperone proteins and cytokines, says a new report from business intelligence provider GBI Research.

The company's latest report* states that first-in-class programs constitute an estimated 27% of the entire psoriasis pipeline, and are predominantly composed of targeted therapies, including cytokine and receptor modulators, nuclear receptor modulators and intracellular kinase inhibitors.

Ling Zhuang, Ph.D., Analyst for GBI Research, says: "There are several novel therapies targeting first-in-class T cell antigens, thanks to a growing understanding of the signaling pathways underlying the psoriasis pathophysiology, in which T cells have been shown to play a substantial role in disease progression."

Therapies that can selectively modulate specific subsets of immune cells, without compromising the entire immune system, have become increasingly desirable, according to GBI Research. One such program is Tregalizumab, a humanized Cluster of Differentiation (CD) 4-specific monoclonal antibody.

Zhuang continues: "In contrast to other anti-CD4 antibodies, Tregalizumab is able to activate the suppressive properties of regulatory T cells. It is currently in Phase II clinical trials for the treatment of rheumatoid arthritis and in Preclinical development for treating psoriasis."

GBI Research states that although no preclinical or clinical efficacy data has been disclosed for the antibody, it has been involved in a lucrative co-development deal worth $480 million between Biotest and Abbott Laboratories.

Other promising psoriasis therapies are targeting novel angiogenic signaling molecules at the psoriatic plaque level, as topical therapies. This has been validated in a small scale, double-blind and randomized clinical study, according to GBI Research.

"With further validation in larger scale clinical studies, insulin receptor substrate-1 inhibitors may prove to be a novel localized therapy for psoriasis, which can be used in conjunction with systemic treatments," Zhuang concludes.

Frontier Pharma: Psoriasis - Identifying and Commercializing First-in-Class Innovation

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

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

2. The Case for Innovation

  • 2.1. Growing Opportunities for Biologic Products
  • 2.2. Diversification of Molecular Targets
  • 2.3. Innovative First-in-Class Product Developments Remain Attractive
  • 2.4. Changes in the Clinical and Commercial Environment Will be More Favorable to Products That Target Niche Indications and Patient Populations
  • 2.5. Innovation in Psoriasis

3. Clinical and Commercial Landscape

  • 3.1. Disease Introduction
  • 3.2. Epidemiology
  • 3.3. Etiology
    • 3.3.1. Genetic Predisposition
    • 3.3.2. Environmental Factors
  • 3.4. Pathophysiology
    • 3.4.1. Keratinocytes
    • 3.4.2. Dendritic Cells
    • 3.4.3. T-Cells
    • 3.4.4. Angiogenesis
    • 3.4.5. Growth Factors
  • 3.5. Symptoms and Co-morbidities
    • 3.5.1. Skin Manifestations
    • 3.5.2. Psoriatic Arthritis
    • 3.5.3. Uveitis
    • 3.5.4. Cardiovascular Disease
    • 3.5.5. Psychological Impact
  • 3.6. Diagnosis of Psoriasis
    • 3.6.1. Diagnosis of Psoriatic Arthritis
  • 3.7. Treatment
    • 3.7.1. Pharmacological Therapies
    • 3.7.2. Topical Medications
    • 3.7.3. Systemic Medications
    • 3.7.4. Non-Pharmacological Therapies
    • 3.7.5. Combination and Rotational Therapies
  • 3.8. Overview of Marketed Products for Psoriasis
    • 3.8.1. Oral Non-Biologic DMARDs
    • 3.8.2. Off-Label Non-Biologic DMARDs
    • 3.8.3. Biologics
    • 3.8.4. Comparative Efficacy and Safety of Marketed Products
    • 3.8.5. Unmet Need

4. Assessment of Psoriasis Pipeline and Innovation

  • 4.1. Overview
  • 4.2. Comparative Efficacy and Safety of Pipeline Programs
  • 4.3. Comparative Distribution of Programs in the Psoriasis Market and Pipeline by Therapeutic Target Family
  • 4.4. Comparative Distribution of Programs with First-in-Class and Established Molecular Targets
  • 4.5. Pipeline Programs Targeting Established Molecular Targets
  • 4.6. First-in-Class Pipeline Programs with Novel Molecular Targets

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

  • 5.1. Cytokines and Receptors
    • 5.1.1. Pipeline Programs Targeting Tumor Necrosis Factor Receptors
    • 5.1.2. Pipeline Programs Targeting Interleukin-6
    • 5.1.3. Pipeline Programs Targeting Interleukin-8
    • 5.1.4. Pipeline Programs Targeting Interleukin-17
    • 5.1.5. Pipeline Programs Targeting Interferon-γ
  • 5.2. B and T Cell Antigens
    • 5.2.1. Pipeline Programs Targeting Cluster of Differentiation 4
    • 5.2.2. Pipeline Programs Targeting Cluster of Differentiation 28
  • 5.3. Intracellular Kinases
    • 5.3.1. Pipeline Programs Targeting Interleukin-1 Receptor-Associated Kinase-4
  • 5.4. Nuclear Receptors
    • 5.4.1. Pipeline Programs Targeting Retinoic Acid Receptor-Related Orphan Receptor
  • 5.5. Growth Factors
    • 5.5.1. Pipeline Programs Targeting Transforming Growth Factor-β Receptor
    • 5.5.2. Pipeline Programs Targeting Insulin Receptor Substrate
  • 5.6. Ion Channels
    • 5.6.1. Pipeline Programs Targeting Calcium Release-Activated Calcium Channel
  • 5.7. Integrins
    • 5.7.1. Pipeline Programs Targeting Vascular Adhesion Protein-1
  • 5.8. Other
    • 5.8.1. Pipeline Programs Targeting F1F0-Adenosine Triphosphate Synthase
    • 5.8.2. Pipeline Programs Targeting Cathepsin S
  • 5.9. Conclusion

6. Deals and Strategic Consolidations

  • 6.1. Licensing Agreements
  • 6.2. Major Co-development Deals
  • 6.3. First-in-Class Developmental Programs Not Involved in Co-Development or Licensing Deals

7. Appendix

  • 7.1. Abbreviations
  • 7.2. References
  • 7.3. Methodology
  • 7.4. Contact Us
  • 7.5. Disclaimer

List of Tables

  • Table 1: Psoriasis Market, Global, First-in-Class Interferon-γ Inhibitors, Pipeline Development
  • Table 2: Psoriasis Market, Global, First-in-Class F1F0-Adenosine Triphosphate Synthase Modulators, Pipeline Development
  • Table 3: Abbreviations

List of Figures

  • Figure 1: Psoriasis, Global, Treatment Algorithm
  • Figure 2: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 1
  • Figure 3: Psoriasis Market, Global, Comparative Safety and Efficacy, 2013 - 2
  • Figure 4: Psoriasis Market, Global, Pipeline Overview, 2013
  • Figure 5: Psoriasis Market, Global, Comparative Safety and Efficacy of Pipeline Products, 2013
  • Figure 6: Psoriasis, Global, Comparative Distribution of Marketed and pipeline Products by Target Family
  • Figure 7: Psoriasis Market, Global, Pipeline, Comparative Distribution of Programs by Established and First-in-Class Targets, 2013
  • Figure 8: Psoriasis Market, Global, Pipeline Products with Established Targets, 2013
  • Figure 9: Psoriasis Market, Global, Pipeline Products with First-in-Class Targets, 2013
  • Figure 10: Psoriasis Market, Global, First-in-Class Tumor Necrosis Factor-α Receptor Modulators, Pipeline Development
  • Figure 11: Psoriasis Market, Global, First-in-Class Interleukin-6 Inhibitors, Pipeline Development
  • Figure 12: Psoriasis Market, Global, First-in-Class Interleukin-8 Inhibitors, Pipeline Development
  • Figure 13: Psoriasis Market, Global, First-in-Class Interleukin-17 Inhibitors, Pipeline Development
  • Figure 14: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 4 Modulators, Pipeline Development
  • Figure 15: Psoriasis Market, Global, First-in-Class Cluster of Differentiation 28 Modulators, Pipeline Development
  • Figure 16: Psoriasis Market, Global, First-in-Class Interleukin-1 Receptor Associated Kinase-4 Inhibitors, Pipeline Development
  • Figure 17: Psoriasis Market, Global, First-in-Class Retinoic Acid Receptor-Related Orphan Receptor Inhibitors, Pipeline Development
  • Figure 18: Psoriasis Market, Global, First-in-Class Transforming Growth Factor-β Receptor Modulators, Pipeline Development
  • Figure 19: Psoriasis Market, Global, First-in-Class Insulin Receptor Substrate Modulators, Pipeline Development
  • Figure 20: Psoriasis Market, Global, First-in-Class Calcium Release-Activated Calcium Channel, Pipeline Development
  • Figure 21: Psoriasis Market, Global, First-in-Class Vascular Adhesion Protein-1 Inhibitors, Pipeline Development
  • Figure 22: Psoriasis Market, Global, First-in-Class Cathepsin S Inhibitors, Pipeline Development
  • Figure 23: Psoriasis Market, Global, Licensing Agreement Analysis 1, 2006-2014
  • Figure 24: Psoriasis Market, Global, Licensing Agreement Analysis 2, 2006-2014
  • Figure 25: Psoriasis Market, Global, Licensing Agreement Deal Analysis, 2006-2014
  • Figure 26: Psoriasis Market, Global, Co-Development Deal Analysis, 2006-2014 - 1
  • Figure 27: Psoriasis Market, Global, Co-Development Deal Analysis, 2006-2014 - 2
  • Figure 28: Psoriasis Market, Global, First-in-Class Programs with no Recorded Prior Deal Involvement, 2006-2014
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