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| Report Code: PP10123 | Published: May 2019 | Pages: 98 | Available format: |
| Therapeutic Area(s): | Ophthalmology | Report Type: Indication Pipeline Reports |
Chapter 1. Research Background
1.1 Research Objectives
1.2 Definition
1.3 Research Scope
1.3.1 Pipeline Drugs by Phase
1.3.2 Pipeline Drugs by Route of Administration
1.4 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown of Primary Research Respondents
2.2.1.1 By industry participant
2.2.1.2 By geography
2.2.1.3 By designation
Chapter 3. Executive Summary
3.1 Voice of KOLs
Chapter 4. Introduction
4.1 Disease Overview
4.2 Causes and Risk Factors
4.3 Signs and Symptoms
4.4 Disease Classification
4.5 Pathophysiology
4.6 Diagnosis
4.7 Epidemiology
4.8 Treatment Algorithm for Graves’ Ophthalmopathy
4.9 Unmet Medical Needs for Treatment of Graves’ Ophthalmopathy
4.9.1 Xxxx
4.9.2 Xxxx
4.9.3 Xxxx
4.9.4 Xxxx
4.9.5 Xxxx
4.1 Key Drivers
4.10.1 Technological Advancements
4.10.2 Xxxx
4.10.3 Xxxx
4.11 Key Barriers
4.11.1 Xxxx
4.12 Technology Overview
4.12.1 Enceladus’s Proprietary Technology
4.12.2 Xxxx
4.13 Drug Designations
Chapter 5. Pipeline Drugs Outlook
5.1 Graves’ Ophthalmopathy Pipeline Drugs Snapshot
5.1.1 Pipeline Drugs Snapshot by Phase
5.1.2 Pipeline Drugs Snapshot by Route of Administration
5.1.3 Pipeline Drugs Snapshot by Company
Chapter 6. Pipeline Products
6.1 Phase III
6.1.1 Teprotumumab
6.1.1.1 Clinical trials
6.1.1.2 Clinical trial results
6.1.1.3 Strategic development activities
6.1.1.4 Designations
6.2 Phase II
6.2.1 RVT-1401
6.2.1.1 Clinical trials
6.2.1.2 Clinical trial results
6.2.1.3 Strategic development activities
6.2.2 XXXX
6.2.2.1 Clinical trials
6.2.2.2 Technology
6.3 Unknown Phase
6.3.1 ATX-GD-59
6.3.1.1 Pre-clinical studies
6.3.1.2 Technology
6.3.1.3 Financing and grants
6.4 Inactive
6.4.1 LIPO-102
6.4.1.1 Clinical trials
6.4.1.2 Clinical trial results
6.4.1.3 Strategic development activities
6.4.1.4 Designations
6.4.1.5 Patents
6.4.2 XXXX
6.4.2.1 Clinical trials
6.5 Discontinued
6.5.1 Lanreotide
6.5.1.1 Clinical trials
6.5.2 XXXX
6.5.2.1 Clinical trials
Chapter 7. Clinical Trials Review
7.1 Clinical Trials by Geography
7.2 Clinical Trials by Trial Status
Chapter 8. Regulatory Framework for Drug Approval
8.1 U.S.
8.2 Europe
8.2.1 Centralized Procedure
8.2.2 Mutual Recognition Procedure
8.2.3 Decentralized Procedure
8.2.4 Nationalized Procedure
8.3 Japan
Chapter 9. Competitive Landscape
9.1 Summary of Strategic Development Activities
9.2 Attribute Analysis
9.3 Expected Launch Time of Clinical Stage Products
9.4 Key Winning Strategies
9.4.1 Technological Advancements
9.4.2 Xxxx
9.4.3 Xxxx
Chapter 10. Company Profiles
10.1 Horizon Pharma plc
10.1.1 Business Overview
10.1.2 Product and Service Offerings
10.1.2.1 Marketed products
10.1.2.2 Pipeline products
10.2 Enceladus Pharmaceuticals BV
10.2.1 Business Overview
10.2.2 Product and Service Offerings
10.2.2.1 Pipeline products
10.3 Roivant Sciences GmbH
10.3.1 Business Overview
10.3.2 Product and Service Offerings
10.3.2.1 Pipeline products
10.4 Apitope International NV
10.4.1 Business Overview
10.4.2 Product and Service Offerings
10.4.2.1 Pipeline products
Chapter 11. Appendix
11.1 Recently Organized/Held Seminars and Conferences
11.2 Upcoming Conferences
11.3 Sources & References
11.4 Abbreviations
11.5 Related Reports
LIST OF TABLES
TABLE 1 COMPANY BENCHMARKING BASED ON DRUG CANDIDATES
TABLE 2 DESCRIPTION OF TEPROTUMUMAB
TABLE 3 CLINICAL TRIALS OF TEPROTUMUMAB
TABLE 4 DESCRIPTION OF RVT-1401
TABLE 5 CLINICAL TRIAL OF RVT-1401
TABLE 6 DESCRIPTION OF XXXX
TABLE 7 CLINICAL TRIAL OF XXXX
TABLE 8 DESCRIPTION OF ATX-GD-59
TABLE 9 DESCRIPTION OF LIPO-102
TABLE 10 CLINICAL TRIAL OF LIPO-102
TABLE 11 DESCRIPTION OF XXXX
TABLE 12 DESCRIPTION OF LANREOTIDE
TABLE 13 CLINICAL TRIAL OF LANREOTIDE
TABLE 14 DESCRIPTION OF XXXX
TABLE 15 CLINICAL TRIAL OF XXXX
TABLE 16 COLLABORATIONS AND LICENSING AGREEMENTS
TABLE 17 ACQUISITIONS
TABLE 18 ATTRIBUTE ANALYSIS - TEPROTUMUMAB AND RVT-1401
TABLE 19 EXPECTED LAUNCH TIME OF CLINICAL STAGE PRODUCTS
TABLE 20 HORIZON PHARMA PLC – AT A GLANCE
TABLE 21 MARKETED PRODUCTS
TABLE 22 PIPELINE PRODUCTS
TABLE 23 ENCELADUS PHARMACEUTICALS BV – AT A GLANCE
TABLE 24 PIPELINE PRODUCTS
TABLE 25 ROIVANT SCIENCES GMBH – AT A GLANCE
TABLE 26 SUBSIDIARIES/VANTS OF ROIVANT SCIENCES GMBH
TABLE 27 PIPELINE PRODUCTS
TABLE 28 APITOPE INTERNATIONAL NV – AT A GLANCE
TABLE 29 PIPELINE PRODUCTS
TABLE 30 RECENTLY ORGANIZED SEMINARS AND CONFERENCES
TABLE 31 UPCOMING SEMINARS AND CONFERENCES
TABLE 32 SOURCES & REFERENCESS
TABLE 33 ABBREVIATION
LIST OF FIGURES
FIG 1 RESEARCH METHODOLOGY
FIG 2 BREAKDOWN OF PRIMARY RESEARCH RESPONDENTS, BY INDUSTRY PARTICIPANT
FIG 3 BREAKDOWN OF PRIMARY RESEARCH, BY GEOGRAPHY
FIG 4 BREAKDOWN OF PRIMARY RESEARCH, BY DESIGNATION
FIG 5 TREATMENT ALGORITHM FOR GRAVES’ OPHTHALMOPATHY
FIG 6 UNMET MEDICAL NEEDS
FIG 7 GRAVES’ OPHTHALMOPATHY PIPELINE DRUGS SNAPSHOT, BY PHASE (2019)
FIG 8 GRAVES’ OPHTHALMOPATHY PIPELINE DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2019)
FIG 9 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY
FIG 10 BREAKDOWN OF CLINICAL TRIALS, BY TRIAL STATUS
FIG 11 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)
FIG 12 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)
FIG 13 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU
FIG 14 MARKETING AUTHORIZATION PROCEDURES IN EU
FIG 15 CENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 16 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL
FIG 17 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 18 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN
FIG 19 EXPECTED LAUNCH TIME