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Myasthenia Gravis - Competitive Analysis 2019

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Myasthenia Gravis - Competitive Analysis 2019
Published: June 1, 2019 Content info: 140 Pages
Description

Myasthenia Gravis (MG) is the prototype neuromuscular disease with the immunological pathogenesis. It is an acquired autoimmune disease affecting synaptic transmission via the neuromuscular junction mainly due to the presence of autoantibodies against the acetylcholine receptors (AChR) between the synaptic space of the skeletal muscles. It leads to an impairment of the neuromuscular transmission and corresponding clinical symptoms such as fluctuating muscle weakness and fatigability.

MG can be managed effectively with therapies that include anticholinesterase agents, rapid immunomodulatory therapies, chronic immunosuppressive agents, and thymectomy. Treatment is individualized and depends upon the age of the patient; the severity of the disease, particularly dictated by respiratory or bulbar involvement; and the pace of progression. The goals of therapy in MG are to render patients minimally symptomatic or better while minimizing side effects from medications. MG is a chronic but treatable disease, and many patients can achieve sustained remission of symptoms and full functional capacity.

Most patients need immunosuppression in addition to symptomatic therapy. Prednisolone and azathioprine represent first choice drugs, whereas several second-choice options are recommended and being considered. The marketed products for the treatment of Myasthenia Gravis include Eculizumab (Alexion Pharmaceuticals); Tacrolimus (Astellas Pharma) and Venoglobulin (Mitsubishi Tanabe Pharma Corporation).

The pipeline development for the treatment of Myasthenia Gravis is robust with approximately 15+ active products in this area. The key players involved in the development of the therapeutics include Akari Therapeutics (Coversin), Alpha Cancer Technologies (ACT-101), AnTolRx (Pre-clinical Program), Argenx (Efgartigimod), Catalyst Pharmaceuticals (Amifampridine Phosphate), CSL Behring (Human normal immunoglobulin G (IgG)), CuraVac (Myasterix), Grifols Therapeutics (IGIV-C), GT Biopharma (GTP-004), Hibernaid (HBN-1 (IV); HBN-100), Immunovant (Roivant Sciences) (RVT-1401), Momenta Pharmaceuticals (M281), Novartis (Iscalimab), Protalex (PRTX-100), Ra Pharmaceuticals (Zilucoplan), Toleranzia (Myasthenia Gravis-Tolerogen), Tolerion (TOL 3034) and UCB Pharma (Rozanolixizumab).

Majority of the drugs under development are monoclonal antibody and small molecule. The development and launch of these therapies are expected to lead to the better treatment and longer life span of the individuals with Myasthenia Gravis.

Table of Contents
Product Code: UMHE19156

Table of Contents

1. REPORT INTRODUCTION

  • 1.1. Objective of the Study
  • 1.2. Secondary Research
  • 1.3. Scope of the report:

2. DISEASE OVERVIEW

  • 2.1. Introduction
  • 2.2. Classification of MG
    • 2.2.1. Congenital MG
    • 2.2.2. Ocular MG
    • 2.2.3. Generalized MG
    • 2.2.4. Transient Neonatal MG
    • 2.2.5. Juvenile MG
  • 2.3. Clinical Classification
  • 2.4. Signs and Symptoms
  • 2.5. Causes
  • 2.6. Pathogenesis
  • 2.7. Pathophysiology
    • 2.7.1. Presynaptic Surface
    • 2.7.2. Synaptic Cleft
    • 2.7.3. Postsynaptic Surface
    • 2.7.4. The Acetylcholine Receptor
    • 2.7.5. Neuromuscular Junction Formation and Muscle-Specific Kinase
    • 2.7.6. Safety Factor for Neuromuscular Transmission
    • 2.7.7. Immunopathology
    • 2.7.8. Autoantibodies in MG
    • 2.7.9. Cellular Autoimmunity
    • 2.7.10. Cytokine Influences
    • 2.7.11. The Thymus in MG Pathogenesis
    • 2.7.12. The Differential Involvement of Muscle Groups by MG
  • 2.8. Diagnosis
    • 2.8.1. Differential Diagnosis
  • 2.9. Treatment
    • 2.9.1. International Consensus guidance for management of Myasthenia Gravis
      • 2.9.1.1. Development of guidance treatment statements
    • 2.9.2. Myasthenia gravis: Association of British Neurologists' Management Guidelines
      • 2.9.2.1. International Consensus Guidance for Management of Myasthenia Gravis
      • 2.9.2.2. Treatment of Generalized Myasthenia Gravis
      • 2.9.2.3. Management of side effects: Propantheline or mebeverine can help cholinergic side effects
      • 2.9.2.4. Assessment and Management of the relapsing patient with Myasthenia
    • 2.9.3. Japanese Clinical Guidelines for Myasthenia Gravis
      • 2.9.3.1. Recommendations
      • 2.9.3.2. Thymectomy for non-thymomatous patients
        • 2.9.3.2.1. Recommendations
      • 2.9.3.3. Oral immunosuppressive therapy
        • 2.9.3.3.1. Recommendations
      • 2.9.3.4. High-dose Intravenous Methylprednisolone treatment
        • 2.9.3.4.1. Recommendations
      • 2.9.3.5. IVIg treatment
        • 2.9.3.5.1. Recommendations
      • 2.9.3.6. PE/PP
        • 2.9.3.6.1. Recommendations
      • 2.9.3.7. Treatment for anti-AChR antibody-negative patients (including MuSK-MG)
        • 2.9.3.7.1. Recommendations
      • 2.9.3.8. Treatment strategies for ocular MG
        • 2.9.3.8.1. Recommendations
      • 2.9.3.9. Treatment Strategies for LOMG and elderly MG patients
        • 2.9.3.9.1. Recommendations
  • 2.10. Treatment Algorithm

3. PRODUCTS ANALYSIS BY TECHNOLOGY

  • 3.1. Product Analysis of the Technology

4. PRODUCTS ANALYSIS BY DESIGNATION

  • 4.1. Comparative Analysis

5. TOTAL NUMBER OF MARKETED AND EMERGING PRODUCTS

  • 5.1. Comparative Analysis

6. LIST OF MARKETED PRODUCTS

  • 6.1. List of Marketed Products
  • 6.2. Eculizumab: Alexion Pharmaceuticals
    • 6.2.1. Product Description
    • 6.2.2. Regulatory Milestones
      • 6.2.2.1. Approval
    • 6.2.3. Research and Development
      • 6.2.3.1. Clinical Studies
        • 6.2.3.1.1. Phase III
        • 6.2.3.1.2. Results of Analysis
      • 6.2.3.2. Current Pipeline Activity
        • 6.2.3.2.1. Phase III
    • 6.2.4. Product Development Activities
      • 6.2.4.1. Patent Dispute
      • 6.2.4.2. Acquisition
      • 6.2.4.3. Designation
      • 6.2.4.4. Patent
  • 6.3. Tacrolimus: Astellas
    • 6.3.1. Product Description
    • 6.3.2. Regulatory Milestones
      • 6.3.2.1. Approval
    • 6.3.3. Research and Development
      • 6.3.3.1. Clinical Studies
    • 6.3.4. Product Development Activities
      • 6.3.4.1. Designation
  • 6.4. Venoglobulin IH: Mitsubishi Tanabe Pharma Corporation
    • 6.4.1. Product Description
    • 6.4.2. Regulatory Milestones
      • 6.4.2.1. Approval
      • 6.4.2.2. Clinical Studies
        • 6.4.2.2.1. Results of Analysis
    • 6.4.3. Product Development Activities
      • 6.4.3.1. Merger
      • 6.4.3.2. Designation

7. PIPELINE THERAPEUTICS AT A GLANCE

  • 7.1. Pipeline Therapeutics at a Glance

8. COMPARATIVE ANALYSIS

  • 8.1. Total Number of Emerging Products in Myasthenia Gravis

9. LATE PHASE PRODUCTS (PHASE III)

  • 9.1. Comparative Analysis
  • 9.2. Amifampridine Phosphate: Catalyst Pharmaceuticals
    • 9.2.1. Product Description
    • 9.2.2. Research and Development
      • 9.2.2.1. Clinical Studies
        • 9.2.2.1.1. Phase III
        • 9.2.2.1.2. Phase II
        • 9.2.2.1.3. Results of Analysis
    • 9.2.3. Product Development Activities
      • 9.2.3.1. Agreement
      • 9.2.3.2. Designation
  • 9.3. Efgartigimod: Argenx
    • 9.3.1. Product Description
    • 9.3.2. Research and Development
      • 9.3.2.1. Clinical Studies
        • 9.3.2.1.1. Phase III
        • 9.3.2.1.2. Results of Analysis
    • 9.3.3. Product Development Activities
      • 9.3.3.1. Designation
      • 9.3.3.2. Grant
      • 9.3.3.3. Technology
  • 9.4. Human normal immunoglobulin G (IgG): CSL Behring
    • 9.4.1. Product Description
    • 9.4.2. Research and Development
      • 9.4.2.1. Clinical Studies
        • 9.4.2.1.1. Phase III
        • 9.4.2.1.2. Phase II
  • 9.5. IGIV-C: Grifols Therapeutics
    • 9.5.1. Product Description
    • 9.5.2. Research and Development
      • 9.5.2.1. Clinical Studies
        • 9.5.2.1.1. Phase III
        • 9.5.2.1.2. Phase II

10. MID PHASE PRODUCTS (PHASE II)

  • 10.1. Comparative Analysis
  • 10.2. Iscalimab: Novartis
    • 10.2.1. Product Description
    • 10.2.2. Research and Development
      • 10.2.2.1. Pre-clinical Studies
      • 10.2.2.2. Clinical Studies
        • 10.2.2.2.1. Phase II
        • 10.2.2.2.2. Results of Analysis
  • 10.3. M281: Momenta Pharmaceuticals
    • 10.3.1. Product Description
    • 10.3.2. Research and Development
      • 10.3.2.1. Clinical Studies
        • 10.3.2.1.1. Phase II
        • 10.3.2.1.2. Phase I
        • 10.3.2.1.3. Results of Analysis
  • 10.4. Rozanolixizumab: UCB Pharma
    • 10.4.1. Product Description
    • 10.4.2. Research and Development
      • 10.4.2.1. Clinical Studies
        • 10.4.2.1.1. Phase II
        • 10.4.2.1.2. Results of Analysis
  • 10.5. RVT-1401: Immunovant (Roivant Sciences)
    • 10.5.1. Product Description
    • 10.5.2. Research and Development
      • 10.5.2.1. Clinical Studies
        • 10.5.2.1.1. Phase II
    • 10.5.3. Product Development Activities
      • 10.5.3.1. Licensing Agreement
  • 10.6. Zilucoplan: Ra Pharmaceuticals
    • 10.6.1. Product Description
    • 10.6.2. Research and Development
      • 10.6.2.1. Clinical Studies
        • 10.6.2.1.1. Phase II
        • 10.6.2.1.2. Results of Analysis
    • 10.6.3. Product Development Activities
      • 10.6.3.1. Technology
      • 10.6.3.2. Patent
  • 10.7. Myasterix: CuraVac
    • 10.7.1. Product Description
    • 10.7.2. Research and Development
      • 10.7.2.1. Clinical Studies
        • 10.7.2.1.1. Phase I/II
        • 10.7.2.1.2. Results of Analysis
    • 10.7.3. Product Development Activities
      • 10.7.3.1. Designation
      • 10.7.3.2. Grant

11. EARLY STAGE PRODUCTS (PHASE I)

  • 11.1. Comparative Analysis
  • 11.2. GTP-004: GT Biopharma
    • 11.2.1. Product Description
    • 11.2.2. Research and Development
      • 11.2.2.1. Clinical Studies
        • 11.2.2.1.1. Phase I
        • 11.2.2.1.2. Results of Analysis
    • 11.2.3. Product Development Activities
      • 11.2.3.1. Patents

12. PRE-CLINICAL AND DISCOVERY STAGE PRODUCTS

  • 12.1. Comparative Analysis
  • 12.2. ACT-101: Alpha Cancer Technologies
    • 12.2.1. Product Description
    • 12.2.2. Research and Development
      • 12.2.2.1. Pre-clinical Studies
    • 12.2.3. Product Development Activities
      • 12.2.3.1. Designation
  • 12.3. HBN-1 (IV): Hibernaid
    • 12.3.1. Product Description
  • 12.4. Myasthenia Gravis-Tolerogen: Toleranzia
    • 12.4.1. Product Description
  • 12.5. Pre-clinical Program: AnTolRx
    • 12.5.1. Product Description
    • 12.5.2. Product Development Activities
      • 12.5.2.1. Financing
      • 12.5.2.2. Technology
  • 12.6. PRTX-100: Protalex
    • 12.6.1. Product Description
    • 12.6.2. Research and Development
      • 12.6.2.1. Pre-clinical Studies
    • 12.6.3. Product Development Activities
      • 12.6.3.1. Patent
  • 12.7. TOL 3034: Tolerion
    • 12.7.1. Product Description
    • 12.7.2. Product Development Activities
      • 12.7.2.1. Technology
  • 12.8. Coversin: Akari Therapeutics
    • 12.8.1. Product Description
    • 12.8.2. Product Development Activities
      • 12.8.2.1. Patent
      • 12.8.2.2. Financing
      • 12.8.2.3. Merger Agreement
  • 12.9. HBN-100: Hibernaid
    • 12.9.1. Product Description

13. THERAPEUTIC ASSESSMENT

  • 13.1. Assessment by Product Type
  • 13.2. Assessment by Stage and Product Type
  • 13.3. Assessment by Route of Administration
  • 13.4. Assessment by Stage and Route of Administration
  • 13.5. Assessment by Molecule Type
  • 13.6. Assessment by Stage and Molecule Type

14. APPROVAL TIMELINES

  • 14.1. Approval Timelines for Clinical Products

15. ANALYST INSIGHTS

16. INACTIVE PRODUCTS

  • 16.1. Comparative Analysis
  • 16.2. Belimumab: GlaxoSmithKline
    • 16.2.1. Product Description
    • 16.2.2. Research and Development
      • 16.2.2.1. Clinical Studies
        • 16.2.2.1.1. Results of Analysis
  • 16.3. EN101: Amarin Corporation
    • 16.3.1. Product Description
    • 16.3.2. Research and Development
      • 16.3.2.1. Clinical Studies
        • 16.3.2.1.1. Phase IIa
        • 16.3.2.1.2. Results of Analysis
    • 16.3.3. Product Development Activities
      • 16.3.3.1. Designation
      • 16.3.3.2. Agreement
  • 16.4. Tirasemtiv: Cytokinetics
    • 16.4.1. Product Description
    • 16.4.2. Research and Development
      • 16.4.2.1. Clinical Studies
        • 16.4.2.1.1. Phase II
        • 16.4.2.1.2. Results of Analysis
    • 16.4.3. Product Development Activities
      • 16.4.3.1. Collaboration Agreement

List of Tables

  • Table 1: Clinical subtypes of MG
  • Table 2: Features of different subtypes of MG
  • Table 3: Osserman und Genkins classification of myasthenia gravis, modified by the MGFA/Task Force
  • Table 4: Definition of QMG score
  • Table 5: MG-MMT scores
  • Table 6: Proposed Diagnostic Criteria for Myasthenia Gravis
  • Table 7: Products Analysis by Technology
  • Table 8: Products Analysis by Designation
  • Table 9: Total Number of Marketed and Emerging Products
  • Table 10: List of Marketed Products
  • Table 11: Clinical Trial Description: Eculizumab
  • Table 12: General Description: Eculizumab
  • Table 13: Clinical Trial Description: Tacrolimus
  • Table 14: General Description: Tacrolimus
  • Table 15: Clinical Trial Description: Venoglobulin IH 5%
  • Table 16: General Description: Venoglobulin IH 5%
  • Table 17: Total Number of Emerging Products in Myasthenia Gravis
  • Table 18: Late Stage Products (Phase III)
  • Table 19: Clinical Trial Description: Amifampridine Phosphate
  • Table 20: General Description: Amifampridine Phosphate
  • Table 21: Clinical Trial Description: Efgartigimod
  • Table 22: General Description: Efgartigimod
  • Table 23: Clinical Trial Description: Hizentra
  • Table 24: General Description: Human normal immunoglobulin G (IgG)
  • Table 25: Clinical Trial Description: IGIV-C
  • Table 26: General Description: IGIV-C
  • Table 27: Mid Stage Products (Phase II)
  • Table 28: Clinical Trial Description: Iscalimab
  • Table 29: General Description: Iscalimab
  • Table 30: Clinical Trial Description: M281
  • Table 31: General Description: M281
  • Table 32: Clinical Trial Description: Rozanolixizumab
  • Table 33: General Description: Rozanolixizumab
  • Table 34: Clinical Trial Description: RVT-1401
  • Table 35: General Description: RVT-1401
  • Table 36: Clinical Trial Description: Zilucoplan
  • Table 37: General Description: Zilucoplan
  • Table 38: Clinical Trial Description: Myasterix
  • Table 39: General Description: Myasterix
  • Table 40: Early Stage Products (Phase I)
  • Table 41: Clinical Trial Description: GTP-004
  • Table 42: Patents: GTP-004
  • Table 43: General Description: GTP-004
  • Table 44: Pre-clinical and Discovery Stage Products
  • Table 45: General Description: ACT-101
  • Table 46: General Description: HBN-1 (IV)
  • Table 47: General Description: Myasthenia Gravis-Tolerogen
  • Table 48: General Description: Pre-clinical Program
  • Table 49: General Description: PRTX-100
  • Table 50: General Description: TOL 3034
  • Table 51: General Description: Coversin
  • Table 52: General Description: HBN-100
  • Table 53: Assessment by Product Type
  • Table 54: Assessment by Stage and Product Type
  • Table 55: Assessment by Route of Administration
  • Table 56: Assessment by Stage and Route of Administration
  • Table 57: Assessment by Molecule Type
  • Table 58: Assessment by Stage and Molecule Type
  • Table 59: Approval Timelines for Clinical Products
  • Table 60: Inactive Products
  • Table 61: Clinical Trial Description: Belimumab
  • Table 62: General Description: Belimumab
  • Table 63: Clinical Trial Description: EN101
  • Table 64: General Description: EN101
  • Table 65: Clinical Trial Description: Tirasemtiv
  • Table 66: General Description: Tirasemtiv

List of Figures

  • Figure 1: Total Number of Products in Myasthenia Gravis
  • Figure 2: Products Analysis by Designation
  • Figure 3: Total Number of Marketed and Emerging Products
  • Figure 4: Total Number of Emerging Products in Myasthenia Gravis
  • Figure 5: Late Stage Products (Phase III)
  • Figure 6: Mid Stage Products (Phase II)
  • Figure 7: Early Stage Products (Phase I)
  • Figure 8: Pre-clinical and Discovery Stage Products
  • Figure 9: Assessment by Product Type
  • Figure 10: Assessment by Stage and Product Type
  • Figure 11: Assessment by Route of Administration
  • Figure 12: Assessment by Stage and Route of Administration
  • Figure 13: Assessment by Molecule Type
  • Figure 14: Assessment by Stage and Molecule Type
  • Figure 15: Approval Timelines for Clinical Products
  • Figure 16: Inactive Products
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