Global Myasthenia Gravis - Pipeline Analysis 2019

Global Myasthenia Gravis - Pipeline Analysis 2019

Global Myasthenia Gravis - Pipeline Analysis 2019

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$3,350

Published: Jun-2019

Pages:121

Table:56

Figure:14

Report ID:UMHE19155

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.

Myasthenia gravis affects both men and women and most commonly impacts young adult women (under 40) and older men (over 60), but it can occur at any age, including childhood.  The indication is diagnosed based upon a thorough clinical evaluation, detection of characteristic symptoms and physical findings, a detailed patient history and a variety of specialized tests. The diagnosis is suspected based on a characteristic distribution of muscle weakness and fatigue, without impairment of other neurologic function. The several tests to confirm the diagnosis include a physical and neurological examination, an edrophonium test, a blood test, electrodiagnostic, diagnostic imaging and pulmonary function testing.

Split of Therapeutic Products

 

The recommended treatment for MG may include various measures that may alleviate symptoms, including anticholinesterase drugs (cholinesterase inhibitors) or alter the disease course, such as immunosuppressive drugs or surgery (thymectomy). The initial treatment commonly includes the use of cholinesterase inhibitors, which increase muscle strength by preventing the normal breakdown of the neurotransmitter acetylcholine. Pyridostigmine by mouth (orally) is primarily used.

The therapeutic pipeline of Myasthenia Gravis consists of approximately 15+ products in different stages of development. Currently, 3+ drugs are in Phase III development and major drugs are in mid stage and pre-clinical stage.

Top Company Analysed

Some of the key players include Akari Therapeutics, Alpha Cancer Technologies, AnTolRx, Argenx, Catalyst Pharmaceuticals, CSL Behring, CuraVac, Grifols Therapeutics, GT Biopharma, Hibernaid, Immunovant (Roivant Sciences), Momenta Pharmaceuticals, Novartis, Protalex, Ra Pharmaceuticals, Toleranzia, Tolerion and UCB Pharma.

Scope of the study:

  • Provides an overview of therapeutic pipeline activity for Myasthenia Gravis across the complete product development cycle including all clinical and non-clinical stages
  • The report comprises of detailed profiles of Myasthenia Gravis therapeutic products with key coverage of developmental activities including licensing & collaboration deals, patents issued, designations, technologies and chemical information
  • Therapeutic assessment of the active pipeline products by stage, product type, molecule type, and route of administration
  • Detailed profiles of the dormant and discontinued products have been included in the report

Reasons to buy:

  • The Myasthenia Gravis pipeline presents the detailed profile of drugs. The analysis offered in the report is a combination of deep dive secondary research and input from Key Opinion Leader of the industry
  • The report presents a quick review of the current scenario regarding the drug development of the indication at one glance
  • The report covers in-depth analysis of prominent industry peers with a primary focus on company consolidation, designation, technology, agreements and patents regarding the therapy
  • Detailed examination on diagnosis, treatment and guidelines prevailing in the industry
  • Examination of industry attractiveness with the help of approval timelines
  • The study comprehensively covers the market across drugs in different phases of development
  • Extensive domain knowledge on therapy areas support the client in decision-making process regarding their therapeutic portfolio by identifying the reason behind the dormancy and discontinuation of the products

Customization Options:

The Myasthenia Gravis pipeline analysis report can be customized to the country level or any other competitive segment. Besides this, UMI understands that you may have your own business need, hence we also provide fully customized solutions to clients.

             
             
  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 PIPELINE THERAPEUTICS AT A GLANCE
    3.1 Pipeline Therapeutics at a Glance
  4 COMPARATIVE ANALYSIS
    4.1 Number of Products in Myasthenia Gravis
  5 LATE PHASE PRODUCTS (PHASE III)
    5.1 Comparative Analysis
    5.2 Amifampridine Phosphate: Catalyst Pharmaceuticals
      5.2.1 Product Description
      5.2.2 Research and Development
        5.2.2.1 Clinical Studies
          5.2.2.1.1 Phase III
          5.2.2.1.2 Phase II
          5.2.2.1.3 Results of Analysis
      5.2.3 Product Development Activities
        5.2.3.1 Agreement
        5.2.3.2 Designation
    5.3 Efgartigimod: Argenx
      5.3.1 Product Description
      5.3.2 Research and Development
        5.3.2.1 Clinical Studies
          5.3.2.1.1 Phase III
          5.3.2.1.2 Results of Analysis
      5.3.3 Product Development Activities
        5.3.3.1 Designation
        5.3.3.2 Grant
        5.3.3.3 Technology
    5.4 Human normal immunoglobulin G (IgG): CSL Behring
      5.4.1 Product Description
      5.4.2 Research and Development
        5.4.2.1 Clinical Studies
          5.4.2.1.1 Phase III
          5.4.2.1.2 Phase II
    5.5 IGIV-C: Grifols Therapeutics
      5.5.1 Product Description
      5.5.2 Research and Development
        5.5.2.1 Clinical Studies
          5.5.2.1.1 Phase III
          5.5.2.1.2 Phase II
  6 MID PHASE PRODUCTS (PHASE II)
    6.1 Comparative Analysis
    6.2 Iscalimab: Novartis
      6.2.1 Product Description
      6.2.2 Research and Development
        6.2.2.1 Pre-clinical Studies
        6.2.2.2 Clinical Studies
          6.2.2.2.1  
          6.2.2.2.2  
    6.3 M281: Momenta Pharmaceuticals
      6.3.1 Product Description
      6.3.2 Research and Development
        6.3.2.1 Clinical Studies
          6.3.2.1.1 Phase II
          6.3.2.1.2 Phase I
          6.3.2.1.3 Results of Analysis
    6.4 Rozanolixizumab: UCB Pharma
      6.4.1 Product Description
      6.4.2 Research and Development
        6.4.2.1 Clinical Studies
          6.4.2.1.1 Phase II
          6.4.2.1.2 Results of Analysis
    6.5 RVT-1401: Immunovant (Roivant Sciences)
      6.5.1 Product Description
      6.5.2 Research and Development
        6.5.2.1 Clinical Studies
          6.5.2.1.1 Phase II
      6.5.3 Product Development Activities
        6.5.3.1 Licensing Agreement
    6.6 Zilucoplan: Ra Pharmaceuticals
      6.6.1 Product Description
      6.6.2 Research and Development
        6.6.2.1 Clinical Studies
          6.6.2.1.1 Phase II
          6.6.2.1.2 Results of Analysis
      6.6.3 Product Development Activities
        6.6.3.1 Technology
        6.6.3.2 Patent
    6.7 Myasterix: CuraVac
      6.7.1 Product Description
      6.7.2 Research and Development
        6.7.2.1 Clinical Studies
          6.7.2.1.1 Phase I/II
          6.7.2.1.2 Results of Analysis
      6.7.3 Product Development Activities
        6.7.3.1 Designation
        6.7.3.2 Grant
  7 EARLY STAGE PRODUCTS (PHASE I)
    7.1 Comparative Analysis
    7.2 GTP-004: GT Biopharma
      7.2.1 Product Description
      7.2.2 Research and Development
        7.2.2.1 Clinical Studies
          7.2.2.1.1 Phase I
          7.2.2.1.2 Results of Analysis
      7.2.3 Product Development Activities
        7.2.3.1 Patents
  8 PRE-CLINICAL AND DISCOVERY STAGE PRODUCTS
    8.1 Comparative Analysis
    8.2 ACT-101: Alpha Cancer Technologies
      8.2.1 Product Description
      8.2.2 Research and Development
        8.2.2.1 Pre-clinical Studies
      8.2.3 Product Development Activities
        8.2.3.1 Designation
    8.3 HBN-1 (IV): Hibernaid
      8.3.1 Product Description
    8.4 Myasthenia Gravis-Tolerogen: Toleranzia
      8.4.1 Product Description
    8.5 Pre-clinical Program: AnTolRx
      8.5.1 Product Description
      8.5.2 Product Development Activities
        8.5.2.1 Financing
        8.5.2.2 Technology
    8.6 PRTX-100: Protalex
      8.6.1 Product Description
      8.6.2 Research and Development
        8.6.2.1 Pre-clinical Studies
      8.6.3 Product Development Activities
        8.6.3.1 Patent
    8.7 TOL 3034: Tolerion
      8.7.1 Product Description
      8.7.2 Product Development Activities
        8.7.2.1 Technology
    8.8 Coversin: Akari Therapeutics
      8.8.1 Product Description
      8.8.2 Product Development Activities
        8.8.2.1 Patent
          8.8.2.2 Financing
          8.8.2.3 Merger Agreement
    8.9 HBN-100: Hibernaid
      8.9.1 Product Description
  9 THERAPEUTIC ASSESSMENT
    9.1 Assessment by Product Type
    9.2 Assessment by Stage and Product Type
    9.3 Assessment by Route of Administration
    9.4 Assessment by Stage and Route of Administration
    9.5 Assessment by Molecule Type
    9.6 Assessment by Stage and Molecule Type
  10 APPROVAL TIMELINES
    10.1 Approval Timelines for Clinical Products
  11 ANALYST INSIGHTS  
  12 INACTIVE PRODUCTS  
    12.1 Comparative Analysis
    12.2 Belimumab: GlaxoSmithKline
      12.2.1 Product Description
      12.2.2 Research and Development
        12.2.2.1 Clinical Studies
          12.2.2.1.1 Phase II
          12.2.2.1.2 Results of Analysis
    12.3 EN101: Amarin Corporation
      12.3.1 Product Description
      12.3.2 Research and Development
        12.3.2.1 Clinical Studies
          12.3.2.1.1 Phase IIa
          12.3.2.1.2 Results of Analysis
      12.3.3 Product Development Activities
        12.3.3.1 Designation
        12.3.3.2 Agreement
    12.4 Tirasemtiv: Cytokinetics
      12.4.1 Product Description
      12.4.2 Research and Development
        12.4.2.1 Clinical Studies
          12.4.2.1.1 Phase II
          12.4.2.1.2 Results of Analysis
      12.4.3 Product Development Activities
        12.4.3.1 Collaboration Agreement

Overview of pipeline development activities for Myasthenia Gravis Pipeline Analysis of therapeutic drugs is not limited to drug description and development activities but also focuses on clinical and non-clinical results. It also includes designations, company consolidations & licensing deals, grants, technology and patent details. Therapeutic segmentation of products for Myasthenia Gravis is done based on phase of development. The report comprises of comparative pipeline therapeutics assessment along with detailed drug profile of pipeline products by development stage, therapy type, molecule type, and administration route across this indication. The report also consists of the approval timelines forecasted for the upcoming pipeline therapies. Additionally, Analyst Insight have also been focused upon to give a summary regarding the current market scenario. The detailed profiles of the dormant and discontinued products have been elucidated in the complete report with the relevant reasons for their dormancy and discontinuation.

Secondary Research

Detail secondary study was conducted to obtain the Myasthenia Gravis Pipeline Analysis through company internal sources such as annual reports, performance presentations, press releases, inventory records etc., and external sources including trade journals, news & articles, government publications, competitor publications, sector reports, regulatory bodies publications, safety standard organizations, third-party database and other creditable publications.

The secondary research on internal and external sources is being carried out to source qualitative and quantitative information relating to each market.

  • Company websites, annual reports, quarter reports, financial reports, broker reports, investor presentations and SEC filings
  • Industry trade journals and other literature
  • National government documents, statistical databases and market reports
  • News articles, press releases and web-casts specific to the companies operating in the market
  • Several databases for patents and clinical trials

Main objective of the Myasthenia Gravis - Pipeline Analysis 2019

The current pipeline trends of the Myasthenia Gravis are pinpointed in the study. Investors can gain strategic insights to base their discretion for investments from the qualitative and quantitative analysis performed in the study. Current and future pipeline trends would determine the overall attractiveness of the market, providing a platform for the industrial participant to exploit the untapped market to benefit as first mover advantage. The quantitative objectives for the report include:

  • An overview of therapeutic pipeline activity for Myasthenia Gravis across the complete product development cycle including all clinical and non-clinical stages
  • Analyse the detailed description of Myasthenia Gravis therapeutic products with key coverage of developmental activities including licensing & collaboration deals, patents issued, designations, technologies and chemical information
  • Therapeutic assessment of the active pipeline products by stage, product type, molecule type, and route of administration
  • Detailed profiles of the dormant and discontinued products have been included in the report

Overview of pipeline development activities for Myasthenia Gravis Pipeline Analysis of therapeutic drugs is not limited to drug description and development activities but also focuses on clinical and non-clinical results. It also includes designations, company consolidations & licensing deals, grants, technology and patent details. Therapeutic segmentation of products for Myasthenia Gravis is done based on phase of development. The report comprises of comparative pipeline therapeutics assessment along with detailed drug profile of pipeline products by development stage, therapy type, molecule type, and administration route across this indication. The report also consists of the approval timelines forecasted for the upcoming pipeline therapies. Additionally, Analyst Insight have also been focused upon to give a summary regarding the current market scenario. The detailed profiles of the dormant and discontinued products have been elucidated in the complete report with the relevant reasons for their dormancy and discontinuation.

Secondary Research

Detail secondary study was conducted to obtain the Myasthenia Gravis Pipeline Analysis through company internal sources such as annual reports, performance presentations, press releases, inventory records etc., and external sources including trade journals, news & articles, government publications, competitor publications, sector reports, regulatory bodies publications, safety standard organizations, third-party database and other creditable publications.

The secondary research on internal and external sources is being carried out to source qualitative and quantitative information relating to each market.

  • Company websites, annual reports, quarter reports, financial reports, broker reports, investor presentations and SEC filings
  • Industry trade journals and other literature
  • National government documents, statistical databases and market reports
  • News articles, press releases and web-casts specific to the companies operating in the market
  • Several databases for patents and clinical trials

Main objective of the Myasthenia Gravis - Pipeline Analysis 2019

The current pipeline trends of the Myasthenia Gravis are pinpointed in the study. Investors can gain strategic insights to base their discretion for investments from the qualitative and quantitative analysis performed in the study. Current and future pipeline trends would determine the overall attractiveness of the market, providing a platform for the industrial participant to exploit the untapped market to benefit as first mover advantage. The quantitative objectives for the report include:

  • An overview of therapeutic pipeline activity for Myasthenia Gravis across the complete product development cycle including all clinical and non-clinical stages
  • Analyse the detailed description of Myasthenia Gravis therapeutic products with key coverage of developmental activities including licensing & collaboration deals, patents issued, designations, technologies and chemical information
  • Therapeutic assessment of the active pipeline products by stage, product type, molecule type, and route of administration
  • Detailed profiles of the dormant and discontinued products have been included in the report

Global Myasthenia Gravis - Pipeline Analysis 2019