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Primary Biliary Cholangitis - Pipeline Insight, 2019

August 2019 | 60 pages | ID: P0349B0B7CAEN
DelveInsight

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"Primary Biliary Cholangitis - Pipeline Insight, 2019" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Primary Biliary Cholangitis pipeline landscape is provided which includes the disease overview and Primary Biliary Cholangitis treatment guidelines. The assessment part of the report embraces, in depth Primary Biliary Cholangitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Primary Biliary Cholangitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Primary Biliary Cholangitis Understanding

According to National Organization for Rare Disorders (NORD), Primary Biliary Cholangitis is a chronic, progressive liver disorder that mostly affects women and usually appears during middle age. It leads to inflammation and scarring of the small bile ducts. If PBC is untreated, it can lead to cirrhosis, or scarring of the entire liver, which can lead to liver failure. PBC is divided into four stages with stage 1 being early disease, where this is no significant scarring, to stage 4, which is defined by cirrhosis. The most common symptom of PBC is fatigue. When PBC is very severe, it can lead to yellow discoloration of the skin (jaundice). PBC is common among women of middle age worldwide. The disease ratio among female to male is 9:1.

Primary Biliary Cholangitis Pipeline Development Activities

The report provides insights into different therapeutic candidates in discovery and preclinical, phase 1, phase 2, and phase 3 stage. Drugs under development as a monotherapy or combination therapy are also included. It also analyses key players involved in Primary Biliary Cholangitis targeted therapeutics development with respective active and inactive (dormant or discontinued) projects with the appropriate reasons if available. Primary Biliary Cholangitis pipeline report covers 10+ companies. Some of the key players include Seladelpar (CymaBay Therapeutics), FFP104 (Fast Forward Pharmaceuticals), EDP-305 (Enanta Pharmaceuticals) etc.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university web sites and industry-specific third party sources, etc.

Primary Biliary Cholangitis Analytical Perspective by DelveInsight
  • In-depth Primary Biliary Cholangitis Commercial Assessment of products
This report provides an in-depth Commercial Assessment of therapeutic drugs have been included which comprises of collaborations, Licensing, Acquisition –Deal Value Trends. The sub-segmentation is described in the report which includes Company-Company Collaborations (Licensing / Partnering), Company-Academia Collaborations, and Acquisition analysis in both Graphical and tabulated form.
  • Primary Biliary Cholangitis Clinical Assessment of products
The report comprises of comparative clinical assessment of products by development stage, product type, route of administration, molecule type, and MOA type across this indication.

Scope of the report
  • The Primary Biliary Cholangitis report provides an overview of therapeutic pipeline activity for Primary Biliary Cholangitis across the complete product development cycle including all clinical and non-clinical stages
  • It comprises of detailed profiles of Primary Biliary Cholangitis therapeutic products with key coverage of developmental activities including technology, collaborations, licensing, mergers and acquisition, funding, designations and other product related details
  • Detailed Primary Biliary Cholangitis Research and Development progress and trial details, results wherever available, are also included in the pipeline study
  • Therapeutic assessment of the active pipeline products by development stage, product type, route of administration, molecule type, and MOA type
  • Coverage of dormant and discontinued pipeline projects along with the reasons if available across Primary Biliary Cholangitis
Reasons to Buy
  • Establish a comprehensive understanding of the current pipeline scenario across Primary Biliary Cholangitis to formulate effective R&D strategies
  • Assess challenges and opportunities that influence Primary Biliary Cholangitis R&D
  • Develop strategic initiatives by understanding the focus areas of leading companies.
  • Gather impartial perspective of strategies of the emerging competitors having potentially lucrative portfolio in this space and create effective counter strategies to gain competitive advantage
  • Get in detail information of each product with updated information on each project along with key milestones
  • Devise Primary Biliary Cholangitis in licensing and out licensing strategies by identifying prospective partners with progressing projects for Primary Biliary Cholangitis to enhance and expand business potential and scope
  • Our extensive domain knowledge on therapy areas support the clients in decision-making process regarding their therapeutic portfolio by identifying the reason behind the inactive or discontinued drugs
1. REPORT INTRODUCTION

2. PRIMARY BILIARY CHOLANGITIS

2.1. Primary Biliary Cholangitis Disease Overview
2.2. Primary Biliary Cholangitis History
2.3. Primary Biliary Cholangitis Symptoms
2.4. Primary Biliary Cholangitis Causes
2.5. Primary Biliary Cholangitis Pathophysiology
2.6. Primary Biliary Cholangitis Diagnosis
  2.6.1. Diagnostic Guidelines

3. PRIMARY BILIARY CHOLANGITIS CURRENT TREATMENT PATTERNS

3.1. Treatment Guidelines

4. PRIMARY BILIARY CHOLANGITIS - DELVEINSIGHT’S ANALYTICAL PERSPECTIVE

4.1. In-depth Commercial Assessment
  4.1.1. Primary Biliary Cholangitis companies collaborations, Licensing, Acquisition –Deal Value Trends
    4.1.1.1. Assessment Summary
  4.1.2. Primary Biliary Cholangitis Collaboration Deals
    4.1.2.1. Company-Company Collaborations (Licensing / Partnering) Analysis
    4.1.2.2. Primary Biliary Cholangitis Acquisition Analysis
4.2. Clinical Assessment of Pipeline Drugs
  4.2.1. Assessment by Phase of Development
  4.2.2. Assessment by Product Type (Mono / Combination)
    4.2.2.1. Assessment by Stage and Product Type
  4.2.3. Assessment by Route of Administration
    4.2.3.1. Assessment by Stage and Route of Administration
  4.2.4. Assessment by Molecule Type
    4.2.4.1. Assessment by Stage and Molecule Type
  4.2.5. Assessment by MOA
    4.2.5.1. Assessment by Stage and MOA

5. PRIMARY BILIARY CHOLANGITIS PIPELINE THERAPEUTICS

5.1. Late Stage Products (Phase-III)
  5.1.1. Comparative Analysis
5.2. Mid Stage Products (Phase-II)
  5.2.1. Comparative Analysis
5.3. Early Stage Products (Phase-I)
  5.3.1. Comparative Analysis
5.4. Pre-clinical and Discovery Stage Products
  5.4.1. Comparative Analysis
5.5. Inactive Products

6. PRIMARY BILIARY CHOLANGITIS -PRODUCTS ANALYSIS

6.1. Product Profiles
  6.1.1. CymaBay Therapeutics- Seladelpar
    6.1.1.1. Product Description
      6.1.1.1.1. Product Overview
      6.1.1.1.2. Mechanism of Action
    6.1.1.2. Research and Development
      6.1.1.2.1. Clinical Studies
        6.1.1.2.1.1. Detailed Study Description
        6.1.1.2.1.2. Study Results
        6.1.1.2.1.3. Clinical Trials: Tabular View
    6.1.1.3. Product Development Activities
      6.1.1.3.1. Tabulated Product Summary
        6.1.1.3.1.1. General Description Table
  6.1.2. Fast Forward Pharmaceuticals- FFP104
    6.1.2.1. Product Description
      6.1.2.1.1. Product Overview
      6.1.2.1.2. Mechanism of Action
    6.1.2.2. Research and Development
      6.1.2.2.1. Clinical Studies
        6.1.2.2.1.1. Detailed Study Description
        6.1.2.2.1.2. Study Results
        6.1.2.2.1.3. Clinical Trials: Tabular View
    6.1.2.3. Product Development Activities
      6.1.2.3.1. Tabulated Product Summary
        6.1.2.3.1.1. General Description Table
  6.1.3. Enanta Pharmaceuticals- EDP-305
    6.1.3.1. Product Description
      6.1.3.1.1. Product Overview
      6.1.3.1.2. Mechanism of Action
    6.1.3.2. Research and Development
      6.1.3.2.1. Clinical Studies
        6.1.3.2.1.1. Detailed Study Description
        6.1.3.2.1.2. Study Results
        6.1.3.2.1.3. Clinical Trials: Tabular View
    6.1.3.3. Product Development Activities
      6.1.3.3.1. Tabulated Product Summary
        6.1.3.3.1.1. General Description Table
To be continued in the report…………………………

7. RECENT TECHNOLOGIES

8. PRIMARY BILIARY CHOLANGITIS KEY COMPANIES

8.1. Enanta Pharmaceuticals
8.2. Eli Lilly/Incyte Corporation
8.3. NGM Biopharmaceuticals
8.4. GlaxoSmithKline
8.5. Fast Forward Pharmaceuticals
8.6. GenKyoTex
8.7. Albireo AB
8.8. CymaBay Therapeutics
8.9. Zydus Cadila
8.10. Genfit

9. PRIMARY BILIARY CHOLANGITIS KEY PRODUCTS

9.1. EDP 305
9.2. Baricitinib
9.3. Linerixibat
9.4. Setanaxib
9.5. Odevixibat
9.6. Seladelpar
9.7. Saroglitazar
9.8. Elafibranor
9.9. Linerixibat
9.10. FFP104

10. DORMANT AND DISCONTINUED PRODUCTS

10.1. Dormant Products
  10.1.1. Reasons for being dormant
10.2. Discontinued Products
  10.2.1. Reasons for the discontinuation

11. PRIMARY BILIARY CHOLANGITIS - UNMET NEEDS

12. PRIMARY BILIARY CHOLANGITIS - FUTURE PERSPECTIVES

13. APPENDIX

14. REPORT METHODOLOGY

14.1. Secondary Research
14.2. Expert Panel Validation

LIST OF TABLES

Table 1. Primary Biliary Cholangitis Diagnostic Guidelines
Table 2. Treatment Guidelines
Table 3. Assessment Summary
Table 4. Company-Company Collaborations (Licensing / Partnering) Analysis
Table 5. Primary Biliary Cholangitis Acquisition Analysis
Table 6. Assessment by Phase of Development
Table 7. Assessment by Product Type (Mono / Combination)
Table 8. Assessment by Stage and Product Type
Table 9. Assessment by Route of Administration
Table 10. Assessment by Stage and Route of Administration
Table 11. Assessment by Molecule Type
Table 12. Assessment by Stage and Molecule Type
Table 13. Assessment by MOA
Table 14. Assessment by Stage and MOA
Table 15. Late Stage Products (Phase-III)
Table 16. Mid Stage Products (Phase-II)
Table 17. Early Stage Products (Phase-I)
Table 18. Pre-clinical and Discovery Stage Products
Table 19. Inactive Products
Table 20. Dormant Products
Table 21. Discontinued Products

LIST OF FIGURES

Figure 1. Disease Overview
Figure 2. History
Figure 3. Symptoms
Figure 4. Causes
Figure 5. Pathophysiology
Figure 6. Diagnostic Guidelines
Figure 7. Treatment Guidelines
Figure 8. Primary Biliary Cholangitis companies collaborations, Licensing, Acquisition –Deal Value Trends
Figure 9. Company-Company Collaborations (Licensing / Partnering) Analysis
Figure 10. Primary Biliary Cholangitis Acquisition Analysis
Figure 11. Assessment by Phase of Development
Figure 12. Assessment by Product Type (Mono / Combination)
Figure 13. Assessment by Stage and Product Type
Figure 14. Assessment by Route of Administration
Figure 15. Assessment by Stage and Route of Administration
Figure 16. Assessment by Molecule Type
Figure 17. Assessment by Stage and Molecule Type
Figure 18. Assessment by MOA
Figure 19. Assessment by Stage and MOA
Figure 20. Late Stage Products (Phase-III)
Figure 21. Mid Stage Products (Phase-II)
Figure 22. Early Stage Products (Phase-I)
Figure 23. Pre-clinical and Discovery Stage Products
Figure 24. Inactive Products
Figure 25. Dormant Products
Figure 26. Discontinued Products
Figure 27. Unmet Needs

KEY COMPANIES

Enanta Pharmaceuticals
Eli Lilly
Intercept Pharmaceuticals
NGM Biopharmaceuticals
Alfa Farmaceutici
GlaxoSmithKline
GenKyoTex
Albireo AB
CymaBay Therapeutics
Zydus Cadila
Genfit


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