Multiple Sclerosis Pipeline Insight - 2018

Executive Summary
Multiple Sclerosis: Pipeline Analysis-

2018
 Pipeline Analysis
 Clinical Trial Analysis
 Product Approval Timeline
 Patent Analysis
 Deals, Collaborations
 RoA based Analysis
 MoA based Analysis
 HSD based Analysis
 Analytics on Biologics
 Product Profiles &
Milestones
 Analytics on Dormant &
Report Update:
Discontinued Projects
 Key Companies June 2018
 Emerging Companies
 Company Profiles
GervanoRA Data Services LLP

Goa IT Innovation Center, Goa Chamber of
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INDIA
403722.
info.uk@gervanora.com ramu.jadhav@gervanora.com
sujan.muddasani@gervanora.com vg.nagapuri@gervanora.com
Multiple Sclerosis Pipeline Analysis 2018
Copyright © 2018 by GervanoRA Data Services
Executive Summary
EXECUTIVE SUMMARY
Multiple Sclerosis (MS) is a demyelinating disease of the nerve cell which disables brain
and spinal cord (central nervous system). The body’s immune system attacks myelin
sheath, the protective covering of the nerves causes the demyelination and leads to nerve
damage. This damage slows down or blocks messages between CNS and body.
According to GervanoRA analysis, current

(2017) MS Disease population is XXXX
 GervanoRA’s analysis expects a

steady increase in the disease
population from 2018 to 2023.
 Increase expected at a CAGR of x% in
the forecast period.
MS DRUG PIPELINE HIGHLIGHTS

MS drug pipeline is divided into companies, universities and institutes. We have also
segmented the pipeline according to the molecules’ drug class, route of administration,
mechanism of action and phase of development. As per GervanoRA’s analysis, MS drug pipeline
database includes 71 molecules developed by the companies and 50 being developed by universities
and institutes.
Key Pipeline Highlights include:
Highest Phase
of
 4 molecules are in their pre-registration development
phase and are expected to get approvals
in coming two years. Mechanism of
ROA
 Molecules in their preclinical stage Action
MS Drug
currently dominate the pipeline.
Pipeline
 The companies-Novartis and Sanofi are
making good R&D investments and are Analysis
developing 3 molecules each.
 Among the university molecules, there
Ongoing
Clinical Trials Report Drug Class
of pipeline
are around 30 Preclinical molecules, 10 molecules
in Early R&D and 2 molecules in
clinical stage. Recently
Completed
molecule trials

Executive Summary
Key Pipeline Events- 2018 to 2034

Our analysis on the MS drug pipeline estimates that one molecule will be approved in the
second half of 2018. We expect around 49 molecules to be approved by the US FDA and EU
EMA within the time span from 2021-2025.
GervanoRA’s timeline estimations are based on the current drug candidates’ development
stages. Based on this, we have calculated approval timeline for US Regulatory and
International Approval.
Source: GervanoRA
Pipeline Analysis by Phase of Development Pipeline Analysis by Route of Administration

A number of pharmaceutical companies are investing into According to GervanoRA’s analysis, there are xx
R&D for development of new innovative and effective molecules in the drug pipeline that can be
MS drugs. The drugs are in their Early R&D, Preclinical, administered orally. Orals dominate the MS drug
Phase 1, Phase 2 and Phase 3 stages of development, with pipeline followed by Intravenous injectables. There
a major number being in the preclinical stage. are x orally administered molecules in Phase 3.
We also have identified molecules with other routes
of administration like intradermal,
Intracerebroventricular, Oromucosal Spray and
intramuscular.

Executive Summary
Pipeline Analysis by Drug Class and Mechanism of Action
GervanoRA has provided a comprehensive analysis based on the molecules drug class and
mechanism of action. Major drug classes are Selective sphingosine-1-phosphate receptor
1(S1P1) immunomodulators, Selective Bruton’s Tyrosins Kinase (BTK) inhibitors,
Monoclonal antibodies and Cell therapy.
 There are around X molecules belonging to the drug class of Selective sphingosine-1-
phosphate receptor modulator in different stages of development.
 Novartis recently got an approval for a drug belonging to Selective sphingosine-1-
phosphate receptor modulator.
 There are around XX molecules in their preclinical stage of development belonging to
different classes like Sulforaphanes, Neuro-restorative agents, Cell therapy, etc.
Pipeline Highlights by Developer Type

On account of increasing number of the people suffering from MS, many companies are
involved in the development and introduction of the better and effective treatment options.
Currently there are around 58 companies involved in the drug development pipeline of MS
and around 32 universities and institutes involved in the drug development pipeline of MS.
For the pharmaceutical companies, partnerships with Universities and Institutes are about
gaining access of a molecule and academic investigators that can help establish their product
portfolio. Such opportunities utilized paves a way for technology transfer, spin-outs, seed
funding and venture capital to do the early drug discovery. Presently, 50 molecules are being
developed by Universities and Institutes. The molecules under development by these
universities and institutes are available for licensing, with most of them confirmed through
primary.
Furthermore, a number of emerging
companies are also progressing towards
developing innovative therapies for MS, with
their first MS drug hitting the market in the
coming years. Abide therapeutics,
Commence Bio, ReveraGen BioPharma and
Arrien Pharmaceuticals are some of the
emerging companies.
Source: GervanoRA

Executive Summary
MS Drug Approval Timelines US and Ex-US

We have analyzed the MS drug pipeline providing the scenarios for regulatory approvals in
the US and International (ex US). The International approval timeline is based on the time
taken for the EU approval process. We have built a methodology for the estimation of
approval timelines by conducting a rigorous study of drugs approved in the last decade to
understand the approval pattern and time taken for different drugs for different indications.
As part of this study, we assessed the average time to be taken for each stage of drug
development. For our estimation, we have reviewed the company sourced Press Releases,
Investor Presentations, Annual and Quarterly Updates, SEC Filings, etc.
As per GervanoRA Pipeline Analysis, One molecule was expected to get regulatory approval
in 2018 and with a small deviation, it got approved (May 2018) as per our estimated
timelines. X molecules are expected to get regulatory approvals in 2019 and X molecules in
2020, XX molecules in 2023 and XX molecules in 2024.
TABLE: SAMPLE ESTIMATED TIMELINES FOR APPROVALS
Company Pipeline Molecule HSD Approval Time

(FDA/EU-EMA)
XXXX XXXX Phase 3 H12021(FDA)
Novartis OMB157 Phase 3 XXXX/XXXX
Novartis XXXX XXX XXXX/XXXX
XXXX XXXX Phase 2 2023/2027
XXXX XXXX Early R&D 2028/2034
Endece NDC-1308 Preclinical XXXX(FDA)
XXXX XXXX XXXX 2025/2029
TG Therapeutics, XXXX Phase 3 XXXX/XXXX
Inc
XXXX XXXX Phase 1 2023/2027
Source: GervanoRA
MS Market Overview
Deals (Mergers/ Acquisitions/ Collaborations)
Deal makings are something which pharmaceutical industry cannot stay away from. As the
companies continue with their product success and market growth but somewhere they face
challenges with commercialization.
In Multiple Sclerosis therapeutic area, there are around 31 deals that happened since 2010.
Among 31, there are 10 acquisitions, 13 Collaboration agreements, five licensing agreements,
and agreement termination, merger and settlement each one. More number of Collaboration
agreements has happened in the year 2015.

Executive Summary
Source: GervanoRA
MS Drug Approvals since 2010(US and Ex-US)

MS FDA Approved Drugs MS EMA Approved Drugs
FDA has approved around 12 drugs for the The EMA granted marketing authorization for 11
treatment of multiple sclerosis since 2010. drugs for the treatment of multiple sclerosis in the
Among those, four drugs belong to Novartis, European Union since 2010. From these, one has
three belongs to Biogen, two belongs to Sanofi, been withdrawn and one refused by the EMA.
and remaining three belongs to Genentech,
Acorda and Mylan each one.
TABLE: US FDA APPROVED DRUGS SINCE 2010

Drug Name Company Name Approval Date
Gilenya(Fingolimod)* Novartis 11-May-2018
Gilenya(Fingolimod) Novartis 21-Sept-2010
Ocrevus Genentech 28-Mar-2017
Zinbryta Biogen 27-May-2016+
Plegridy Biogen 15-Aug-2014
Ampyra Acorda 22-Jan-2010
Tecfidera Biogen 27-Mar-2013
Augabio Sanofi 12-Sep-2012
Glatiramer Mylan 03-Oct-2017
Glatopa 40mg Sandoz 12-Feb-2018
Glatopa 20mg Sandoz 16-Apr-2015
Lemtrada Genzyme 14-Nov-2014
Source: GervanoRA

Executive Summary
MS Approved Drug’s Patent Analysis

We have provided an estimated patent expiry of key marketed products launched post 2010
mainly. We have also taken into consideration the comments from companies and ongoing
patent litigations from company SEC filing and patent news. We have covered all key
marketed drugs for patent analysis in this section.
TABLE: GILENYA PATENTS
Sr. Geography Patent on Patent Expiry PTE SPC RDP
No
01 United States XXXX 2013 XXXX - -
02 XXXX Dose XXXX - - -
03 XXXX XXXX 2013 - XXXX XXXX
04 Europe XXXX XXXX - XXXX -
05 XXXX Compound 2013 XXXX XXXX -
06 Japan XXXX XXXX - - -
07 XXXX Formulation XXXX - - -
Source: GervanoRA
MS Clinical Trial Summary

The multiple sclerosis pipeline drugs clinical trials summary gives an insight to ongoing
trials, recently completed trials and planned trials. Currently, there are XX clinical trials that
are ongoing for Phase 3 molecules.
Key Clinical Trial Results Summary
We have also analyzed and summarized key phase 3 and phase 2 clinical trial results which
can be leveraged to provide operational insights into the drug development process to
produce better outcomes and help point scientists in the correct direction.
Key Phase 3 Clinical Trial Results Key Phase 2 Clinical Trial Results
We have considered all phase 3 pipeline We have considered all phase 2 pipeline
molecules’ clinical trials to discuss their molecules’ clinical trials to discuss their
results in this section like Ponesimod of results in this section like Evobrutinib
Johnson & Johnson (Actelion (M2951) of Merck KGaA, RHB-104 of
Pharmaceuticals), Ozanimod of Celgene RedHill Biopharma, ATX-MS-1467 of
Corporation, BIIB098 of Apitope, FLX-787 of Flex Pharma and
Biogen/Alkermes, ADS-5102 of Adamas MN-166 (ibudilast) of MediciNova, Inc
Pharmaceuticals, BAF312 (Secondary along with Adamas Pharmaceutical’s ADS-
progressive multiple sclerosis) and 5102 which is a phase 3 molecules.
OMB157 (Relapsing multiple sclerosis) of
Novartis, Ublituximab (TG-1101) of TG
Therapeutics, Inc, and Masitinib of AB
Science.

Executive Summary
Ongoing Clinical Trial Summary
Phase 3 Ongoing trials

According to the GervanoRA analysis, 14
molecules are undergoing their Phase 3
clinical trial.
 Most of the trials are undergoing
for Relapsing-Remitting type of
Multiple Sclerosis.
 Most of the trials are expected to
complete the trial in the year
XXXX.
 4 trials will be completed in
XXXX followed by 3 in the year
XXXX
Source: GervanoRA
Phase 2 and Phase 1 ongoing trials
Similarly, we have also considered the ongoing trials for Phase 2 and Phase 1. We have
analyzed that XX molecules are currently undergoing Phase 2 trials and XX undergoing
phase 1 trials.
Recently Completed Clinical Trial Summary
GervanoRA also gives a brief analysis on the recently completed Phase 3, Phase 2 and Phase 1
clinical trials. XX Phase 3 trials have been completed in the between the years 2015 and 2018.
There were XX trials completed in the year XXXX, XX in 2016, 4 in 2017 and only 1 in
2018(As of May 2018).
 For Phase 2, we have considered

recently completed trials in the year
2016 and 2017.
 XX trials have been completed in these 2
years. From these, XX trials have been
completed in 2016 and XX in the year
2017.
 Similarly, for Phase 1 we have seen that
XX trials have been completed in the time
span of 2015-2018
Source: GervanoRA

Executive Summary
Withdrawn and Terminated Trials Summary
 As per GervanoRA findings, 10 clinical trials  A total of XX trials have been terminated due to
had been withdrawn for Multiple Sclerosis. reasons like safety, efficacy, lack of funding, etc.
 Due to feasibility reasons, Biogen decided to  XX Phase 1 trials, XX Phase 2 trials and XX Phase 3
withdraw a Phase 3 trial for BG00012. trials have been terminated for Multiple Sclerosis.
 A total of XX clinical trials have been  GervanoRA’s analysis on the terminated trial says that
withdrawn for Relapsing-remitting type of XX trials had been terminated for Relapsing-Remitting
Multiple Sclerosis. type of disease, XX trials for Relapsing and XX trials
for progressive type of MS.
Current and Future Landscape

Key company Profiles and SWOT
A number of companies have made their mark in the development and commercialization of
MS drugs proven to be of great use. The companies also include a robust pipeline addressing
MS. In this segment, we have taken into consideration and profiled the key companies having
approved and pipeline molecules for MS.
Biogen Inc.
Biogen is a global pharmaceutical company focused on developing therapies for neurological
and neurodegenerative diseases. TECFIDERA, AVONEX, PLEGRIDY, TYSABRI,
ZINBRYTA and FAMPYRA are its marketed products for the treatment of Multiple
Sclerosis. TECFIDERA is its largest selling drug; however some of its patents will expire in
the year 2018 and 2019 which can drastically affect its sales. The competition of the MS
drugs is very intense. The drugs compete with a number of marketed products by the
companies Sanofi, Novartis, Bayer Group. The company also has two products currently in
pipeline for MS. BIIB098 and Opicinumab are in Phase 3 and Phase 2, respectively. BIIB098
(formerly known as ALKS 8700) is an oral monomethyl fumarate prodrug for the treatment
of relapsing forms of MS. Opicinumab is anti-LINGO-1 also being developed for the
treatment of relapsing form of MS.
TECFIDERA
Drug Molecule TECFIDERA (dimethyl fumarate) gastro-resistant hard capsules are
Description intended for the treatment of relapsing-remitting type of Multiple
sclerosis.It is indicated as a first-line treatment. It is believed to
activate the Nrf2 pathway that provides a way for cells in the body
to defend themselves against inflammation and oxidative stress.
Molecule Milestone  TECFIDERA of Biogen received approval in the EU on February 3,
2014.
 TECFIDERA of Biogen received approval from the US FDA on
March 27, 2013.
 TECFIDERA of Biogen received approval in Australia and Canada in
2013.
Source: GervanoRA

Executive Summary
Emerging Companies and Product Profiles with Milestones

The market is highly competitive and many clinical stage companies are entering into
development of therapeutics which has the potential to address the unmet needs.
Nutra Pharma Corporation
Nutra Pharma Corporation is a Florida (United States) based Biotechnology Company
founded in 2000. Nutra Pharma is specialized in the acquisition, licensing, and
commercialization of pharmaceutical products and technologies for the management of
neurological disorders, cancer, autoimmune, and infectious diseases, including Multiple
Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN)
and Pain.
RPI-78M
Drug Molecule Description RPI-78M is an extract of cobra venom nicotinic which is an
acetylcholine receptor inhibitor intended for the treatment
of multiple sclerosis. It is designed to produce therapeutic
effect by nicotinic acetylcholine receptor inhibition to treat
pediatric multiple sclerosis. It is also indicated for the
treatment of autoimmune diseases.
Molecule Milestone  On May 31, 2017, Nutra Pharma Announces

Collaboration with the University of Maryland
Bioprocess Scale-Up Facility in Preparation of
Material for Phase II Studies
 On September 8, 2015, Nutra Pharma's RPI-78M
Granted Orphan Drug Status by the US Food and
Drug Administration for the Treatment of Juvenile
Multiple Sclerosis
 On December 20, 2005, Nutra Pharma Reports Final
Results for ReceptoPharm's RPI-78M in Multiple
Sclerosis Animal Model
 On August 02, 2004, Nutra Pharma Engages Research
Group to Study RPI-78M in Multiple Sclerosis Assays
 On August 6th, 2008, Nutra Pharma announces
collaborative agreement with Centers for Disease
Control and Prevention (CDC)
Source: GervanoRA

Executive Summary
TABLE OF CONTENTS
List of Tables (54)

List of Figures (16)
1. INTRODUCTION
1.1. Report Description
1.2. Methodology
1.3. Upcoming Reports
1.4. About Us: GervanoRA Data Services
2. EXECUTIVE SUMMARY
2.1. Reports Major Findings
2.2. Key Pipeline Events 2018 to 2034
2.3. Executive Perspectives
3. DISEASE OVERVIEW
3.1. Disease Definition & Symptoms
3.2. Disease Cause and Classification
3.3. Treatment Algorithm & Guidelines
3.4. Epidemiology and Disease Burden
3.5. Epidemiology Forecast

3.5.1. Forecast Methodology and Assumptions
3.5.2. Forecast

Executive Summary
4. MARKET OVERVIEW
4.1. Deals (Mergers/ Acquisitions / Collaborations)

4.1.1. Acquisitions and Mergers
4.1.2. Collaboration Agreements
4.1.3. Licensing Agreements
4.1.4. Termination Agreements and Settlements
4.2. New Drug Approvals (EMA) Since 2010
4.3. New Drug Approvals (USFDA) Since 2010
4.4. Multiple Sclerosis Patent Analysis (Expires and Genericization)
5. PIPELINE ANALYSIS
5.1. Pipeline Analysis by Stage of Development

5.1.1. Pre-Registration
5.1.2. Phase 3
5.1.3. Phase 2
5.1.4. Phase 1
5.1.5. Preclinical
5.1.6. Early R&D (Discovery)
5.2. Pipeline Analysis by Route of administration

5.2.1. Unmet needs and Opportunities
5.3. Pipeline Analysis by Drug Class

5.4. Pipeline Analysis by Mechanism of Action

5.5. Pipeline Molecules by Companies, Universities and Institutes

5.5.1. Pipeline Molecules Developing By Companies
5.5.2. Pipeline Molecules Developing By Universities and Institutes
6. ESTIMATED DRUG APPROVAL TIMELINES
6.1. Methodology
6.2. Estimated Approval Timelines US & Ex-US

Executive Summary
7. MULTIPLE SCLEROSIS CLINICAL TRIAL SUMMARY
7.1. Multiple Sclerosis Pipeline Analysis by Clinical Trial Results

7.1.1. Key Phase 3 Results
7.1.2. Key Phase 2 Results
7.2. Ongoing Clinical Trials Summary

7.2.1. Phase 3 Ongoing Clinical Trials
7.3. Planned Clinical Trials Summary
7.4. Recently Completed Clinical Trials Summary

7.4.1. Recently Completed Phase 3 Clinical Trials (2015-2018)
7.4.2. Recently Completed Phase 2 Clinical Trials (2016-2017)
7.4.3. Recently Completed Phase 1 Clinical Trial (2015-2018)
8. WITHDRAWN & TERMINATED PROJECTS
8.1. Withdrawn Clinical Trials
8.2. Terminated Trials
9. CURRENT AND FUTURE COMPETITIVE LANDSCAPE
9.1. Established Companies
9.2. Established Company Profiles and SWOT
9.2.1. Biogen
9.2.2. Sanofi
9.2.3. Novartis International AG
9.2.4. Acorda Therapeutics, Inc
9.3. Emerging Companies
9.4. Emerging Company Profiles with Drug Descriptions and Milestones
9.4.1. RedHill Biopharma Ltd
9.4.2. Flex Pharma
9.4.3. Abide Therapeutics

Executive Summary
9.4.4. BrainStorm Cell Therapeutics
9.4.5. Atara Biotherapeutics
9.4.6. Endece,LLC
9.4.7. Commence Bio, Inc
9.4.8. Vaccinex Inc
9.4.9. SanBio, Inc
9.4.10. Q Therapeutics
9.4.11. Bolder BioTechnology, Inc
9.4.12. Artielle Immunotherapeutics
9.4.13. OncoImmune
9.4.14. Cellix Bio
9.4.15. V ClinBio Inc
9.4.16. Akaal Pharma Pty Ltd.
9.4.17. Virtici, LLC
9.4.18. Mapi-Pharma Ltd
9.4.19. Io Therapeutics
9.4.20. Arrien Pharmaceuticals
9.4.21. ReveraGen BioPharma
9.4.22. Nutra Pharma Corporation
9.4.23. RegeneRx Biopharmaceuticals, Inc
9.5. Universities and Institutes
10. ABBREVIATIONS

Executive Summary
List of Tables
TABLE 1: DATA SHOWING TOTAL NUMBER OF PEOPLE HAVING MS, PREVALENCE, MEAN ONSET
OF AGE AND FEMALE TO MALE RATIO
TABLE 2: DATA SHOWING TOTAL NUMBER OF PEOPLE HAVING MS, PREVALENCE, MEAN ONSET
OF AGE AND FEMALE TO MALE RATIO IN EUROPEAN COUNTRIES
TABLE 3: GLOBAL MS EPIDEMIOLOGY (2016), FORECAST (2017-2023)
TABLE 4: MAJOR ACQUISITIONS HAPPENED IN MS THERAPEUTIC AREA SINCE 2010
TABLE 5: MAJOR COLLABORATIVE AGREEMENTS IN MS THERAPEUTIC AREA
TABLE 6: MAJOR LICENSING AGREEMENTS IN MS THERAPEUTIC AREA
TABLE 7: MAJOR TERMINATION AND SETTLEMENT AGREEMENTS IN MS THERAPEUTIC AREA
TABLE 8: EMA OR EX-US DRUG APPROVALS SINCE 2010
TABLE 9: USFDA APPROVED DRUGS SINCE 2010
TABLE 10: GILENYA PATENTS
TABLE 11: TECFIDERA PATENTS
TABLE 12: PLEGRIDY PATENTS
TABLE 13: AMPYRA/FAMPYRA PATENTS
TABLE 14: AUBAGIO PATENTS COVERAGE AND EXPIRY
TABLE 15: LEMTRADA PATENTS COVERAGE AND EXPIRY
TABLE 16: ZYNBRYTA PATENTS
TABLE 17: SUMMARY OF COMPANY PIPELINE MOLECULES BY STAGE OF DEVELOPMENT
TABLE 18: FILING/UNDER REVIEW MOLECULES
TABLE 19: LIST OF PIPELINE MOLECULES IN PHASE 3 DEVELOPMENT STAGE
TABLE 20: LIST OF PHASE 2 MOLECULES
TABLE 21: LIST OF PHASE 1 MOLECULES
TABLE 22: LIST OF PRECLINICAL MOLECULES
TABLE 23: LIST OF EARLY R&D MOLECULES
TABLE 24: ORALLY ADMINISTERED KEY PIPELINE MOLECULES
TABLE 25: INTRAVENOUSLY ADMINISTERED KEY PIPELINE MOLECULES
TABLE 26: SUBCUTANEOUSLY ADMINISTERED KEY PIPELINE MOLECULES
TABLE 27: LIST OF COMPANIES WITH PIPELINE MOLECULES IN DIFFERENT DEVELOPMENT STAGES
TABLE 28: UNIVERSITY AND INSTITUTE’S PIPELINE MOLECULES AVAILABLE FOR LICENSING
TABLE 29: ESTIMATED APPROVAL TIMELINES OF PIPELINE MOLECULES
TABLE 30: POINT CLINICAL TRIALS STUDY DESIGN
TABLE 31: OZANIMOD SUNBEAM STUDY RESULTS
TABLE 32: OZANIMOD RADIANCE PART B STUDY RESULTS
TABLE 33: ADVERSE EVENTS OF BIIB098/ALKS 8700 IN EVOLVE-MS-1 STUDY
TABLE 34: EVOBRUTINIB (M2951) PHASE 2 CLINICAL TRIALS STUDY DESIGN
TABLE 35: RHB-104 PHASE 2 CLINICAL TRIALS STUDY DESIGN
TABLE 36: ANNUALIZED RELAPSE RATES (ARR) OF IN CEASE-MS STUDY OF RHB-104
TABLE 37: ATX-MS-1467 - APITOPE PHASE 2 CLINICAL STUDY DESIGN

Executive Summary
TABLE 38: PHASE 3 ONGOING CLINICAL TRIALS

TABLE 41: PLANNED CLINICAL TRIALS FOR MULTIPLE SCLEROSIS
TABLE 42: RECENTLY COMPLETED PHASE 3 TRIALS (2015-2018)
TABLE 45: WITHDRAWN CLINICAL TRIALS FOR MULTIPLE SCLEROSIS
TABLE 46: TERMINATED CLINICAL TRIALS FOR MULTIPLE SCLEROSIS
TABLE 47: COMPANY SNAPSHOT, BIOGEN
TABLE 48: MAJOR PRODUCTS REVENUES, BIOGEN
TABLE 49: COMPANY SNAPSHOT, SANOFI
TABLE 50: MAJOR PRODUCTS, SANOFI
TABLE 51: COMPANY SNAPSHOT, NOVARTIS
TABLE 52: MAJOR PRODUCTS, NOVARTIS
TABLE 53: COMPANY SNAPSHOT, ACORDA THERAPEUTICS
TABLE 54: UNIVERSITY AND INSTITUTES’S PIPELINE MOLECULES AVAILABLE FOR LICENSING
List of Figures
FIGURE 1: GLOBAL MS EPIDEMIOLOGY, CURRENT TREND AND FORECAST
FIGURE 2: OVERALL DEALS ACTIVITY IN MS THERAPEUTIC AREA
FIGURE 3: PIPELINE MOLECULES WITH ROUTES OF ADMINISTRATIONS
FIGURE 4: UNIVERSITY MOLECULES FOR MS BY PHASE OF DEVELOPMENT
FIGURE 5: ANNUALIZED RELAPSE RATES OF OZANIMOD V/S INF IN SUNBEAM STUDY
FIGURE 6: REDUCTION IN GADOLINIUM-ENHANCED MRI LESIONS WHEN USED OZANIMOD V/S INF
FIGURE 7: REDUCTION IN NEW OR ENLARGING T2 LESIONS WHEN USED OZANIMOD V/S INF
FIGURE 8: ANNUALIZED RELAPSE RATES OF OZANIMOD V/S INF IN RADIANCE PART B STUDY
FIGURE 9: PERCENTAGE REDUCTION IN NEW OR ENLARGING T2 LESIONS BY USING OZANIMOD
V/S INF IN RADIANCE PART B STUDY
FIGURE 10: PERCENTAGE REDUCTION IN GADOLINIUM-ENHANCED MRI LESIONS BY USING
OZANIMOD V/S INF IN RADIANCE PART B STUDY
FIGURE 11: PERCENTAGE REDUCTION IN BRAIN VOLUME LOSS BY USING OZANIMOD V/S INF IN
RADIANCE PART B STUDY
FIGURE 12: ONGOING PHASE 3 TRIALS BY MS TYPE
FIGURE 13: RECENTLY COMPLETED PHASE 3 TRIALS BY DISEASE TYPE
FIGURE 14: RECENTLY COMPLETED PHASE 3 TRIALS BY MAJOR COMPANIES
FIGURE 15: RECENTLY COMPLETED TRIALS, MAJOR COMPANIES V/S DISEASE TYPE
FIGURE 16: RECENTLY COMPLETED PHASE 3 TRIALS BY DISEASE TYPE


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Executive Summary

Multiple Sclerosis: Pipeline Analysis-

GervanoRA Data Services LLP

According to GervanoRA analysis, current

 GervanoRA’s analysis expects a

MS DRUG PIPELINE HIGHLIGHTS

Multiple Sclerosis Pipeline Analysis 2018

Key Pipeline Events- 2018 to 2034

Pipeline Analysis by Phase of Development Pipeline Analysis by Route of Administration

Multiple Sclerosis Pipeline Analysis 2018

Pipeline Analysis by Drug Class and Mechanism of Action

Pipeline Highlights by Developer Type

Multiple Sclerosis Pipeline Analysis 2018

MS Drug Approval Timelines US and Ex-US

Company Pipeline Molecule HSD Approval Time

Multiple Sclerosis Pipeline Analysis 2018

MS Drug Approvals since 2010(US and Ex-US)

TABLE: US FDA APPROVED DRUGS SINCE 2010

Multiple Sclerosis Pipeline Analysis 2018

MS Approved Drug’s Patent Analysis

MS Clinical Trial Summary

Multiple Sclerosis Pipeline Analysis 2018

Ongoing Clinical Trial Summary

Phase 3 Ongoing trials

Phase 2 and Phase 1 ongoing trials

 For Phase 2, we have considered

Multiple Sclerosis Pipeline Analysis 2018

Withdrawn and Terminated Trials Summary

Current and Future Landscape

Multiple Sclerosis Pipeline Analysis 2018

Emerging Companies and Product Profiles with Milestones

Molecule Milestone  On May 31, 2017, Nutra Pharma Announces

Multiple Sclerosis Pipeline Analysis 2018

List of Tables (54)

1.1. Report Description

1.3. Upcoming Reports

1.4. About Us: GervanoRA Data Services

2.1. Reports Major Findings

2.2. Key Pipeline Events 2018 to 2034

2.3. Executive Perspectives

3.1. Disease Definition & Symptoms

3.2. Disease Cause and Classification

3.3. Treatment Algorithm & Guidelines

3.4. Epidemiology and Disease Burden

3.5. Epidemiology Forecast

Multiple Sclerosis Pipeline Analysis 2018

4.1. Deals (Mergers/ Acquisitions / Collaborations)

4.2. New Drug Approvals (EMA) Since 2010

4.3. New Drug Approvals (USFDA) Since 2010

4.4. Multiple Sclerosis Patent Analysis (Expires and Genericization)

5.1. Pipeline Analysis by Stage of Development

5.2. Pipeline Analysis by Route of administration

5.3. Pipeline Analysis by Drug Class

5.4. Pipeline Analysis by Mechanism of Action

5.5. Pipeline Molecules by Companies, Universities and Institutes

6. ESTIMATED DRUG APPROVAL TIMELINES

6.2. Estimated Approval Timelines US & Ex-US

Multiple Sclerosis Pipeline Analysis 2018

7. MULTIPLE SCLEROSIS CLINICAL TRIAL SUMMARY

7.1. Multiple Sclerosis Pipeline Analysis by Clinical Trial Results

7.2. Ongoing Clinical Trials Summary

7.3. Planned Clinical Trials Summary

7.4. Recently Completed Clinical Trials Summary

8. WITHDRAWN & TERMINATED PROJECTS

8.1. Withdrawn Clinical Trials

8.2. Terminated Trials