CNS Drug Discoveries: Multiple Sclerosis Chapter

Date: August 22, 2008
Pages: 128
Price:
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: C59BCB7BAFEEN
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CNS Drug Discoveries: Multiple Sclerosis Chapter
Multiple sclerosis

With the launch of up to 12 new disease-modifying agents, three vaccines and one novel drug designed to treat the symptoms of multiple sclerosis (MS) and improve quality of life, the MS market is in an exciting phase of evolution.

The MS market is estimated to be worth almost US$8 billion in 2008, with a growth rate of 10.6% year-on-year. It is the fifth largest segment of the CNS markets considered in this report and has attracted considerable R&D investment from the big pharmaceutical companies, biotechnology companies and specialty pharma.

Over the next six years a number of oral agents are expected to be launched that could drastically change the way in which MS patients are treated. These include: Novartis' fingolimod, Teva's laquinimod, Merck KGaA’s Mylinax (cladribine), sanofi-aventis' teriflunomide and Biogen Idec's BG-12 in Phase III development, and GSK/Mitsubishi Tanabe Pharma's firategrast, MediciNova's ibudilast and Biogen/UCB's CDP323 in Phase II development.

Three companies have taken on the ambitious task of developing vaccines to treat MS and each has adopted a unique approach to addressing the underlying causes of the disease. Orchestra Therapeutic's NeuroVax targets three proteins expressed on T-cell receptors whilst Opexa Therapeutics' Tovaxin uses attenuated autologous cells to stimulant an immune response. Bayhill Therapeutics is developing BHT-3009, a tolerising DNA vaccine. All vaccines are in Phase II development and could reach market by 2012.

Key MS questions answered:
  • What is the estimated global population for MS in 2014 and what % will be diagnosed and treated?
  • Which off-patent MS treatments are resistant to generic competition?
  • Will Biogen Idec, Teva and Merck KGaA be able to defend their leading positions in 5 years time?
  • There are 7 late-phase pipeline products which target the underlying cause of MS – what are their strengths and weaknesses?

Key products analysed and forecast

BG-12 - Biogen Idec
Campath - Bayer
Fingolimod - Novartis
Lacquinimod - Teva
MBP 8298 - BioMS/Lilly
Mylinax - Merck KGaA
Teriflunomide - sanofi-aventis
Neurelan - Elan/Acorda

MULTIPLE SCLEROSIS CONTENTS

Executive Summary

THE FACTS

What is multiple sclerosis and why are we interested in it?
Patient Statistics
- Incidence, diagnosis rates and treatment; now and in the future
- Multiple sclerosis categories
Patient Model
The treatable multiple sclerosis patient population growth 2007A - 2014E
Drug Growth Drivers
Drug Growth Risks/Dampeners

THE MARKET

Global Multiple Sclerosis Market
Global Sales Split
- The major players
- Players and products in 2007
- Players and products in 2014

CURRENT MS TREATMENTS

- Leading brands
- Current products’ patent exposure
Analysis of Leading Brands
- Disease-modifying agents
Global Sales Forecasts of Current Treatments 2007A - 2014E

NEW DRUGS IN R&D

Analysis of Phase lll Drugs
- Disease-modifying agents
- Multiple sclerosis symptoms
Global Sales Forecasts of Phase lll Multiple Sclerosis Drugs 2007A - 2014E
Analysis of Phase ll Drugs
- Disease-modifying agents
- Vaccines
Global Sales Forecasts of Phase ll Multiple Sclerosis Drugs 2007A - 2014E
Competitor Ratio Analysis - Products
Competitor Ratio Analysis - Companies
- Winners and losers
Discontinuation of Drugs

APPENDICES

Clinical Diagnostic Test for Multiple Sclerosis
Expanded Disability Status Scale
Phase Transition Probability
Patient Model
Global Multiple Sclerosis Drugs Sales 2007A-2014E
Competitor Ratio Analysis Criteria
MULTIPLE SCLEROSIS

EXECUTIVE SUMMARY

THE FACT S

What is multiple sclerosis and why are we interested in it?

PATIENT STATISTICS

Incidence, diagnosis rates and treatment; now and in the future
MS Categories
Types of MS

PATIENT MODEL

The treatable MS patient population will have a CAGR 2007E-2014E - 2.5 per cent
Summary of Patient Population Forecasts (2007A-2014E)
Model Assumptions

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

THE MS MARKET

Global CNS Market (US$91.9 billion)
The Major Players
Market Share of Major MS Players by Sales (Dec 2007A)
Players and Products in 2007
Players and Products in 2014

CURRE NT MS TRE ATMENTS

Leading Brands
Comparison of Leading MS Agents
Current Products' Patent Exposure
Patent Exposure of Leading MS Brands

ANALYSIS OF LEADING BRANDS

Disease-modifying Agents
Avonex
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Betaferon/Betaseron
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Copaxone
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Rebif
    Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Competitor ratio analysis
Tysabri
  Novelty/rationale for mechanism of action
    Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Novantrone
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis

GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A-2014E

Sales Forecasts of Current Leading MS Drugs
Model Assumptions

NEW DRUGS IN R&D

Drugs in Development to Treat MS

ANALYSIS OF PHASE III DRUGS

New Drugs in Phase III Development to Treat MS
Disease-modifying Agents
BG-12
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Campath
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Fingolimod
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Laquinimod
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
MBP8298
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Mylinax
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Teriflunomide
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
MS Symptoms
Neurelan
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Trial MS-F202: Timed 25-foot Walk Response Rate of MS Patients Treated with Fampridine SR
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis

GLOBAL SALES FORECASTS OF PHASE III MS DRUGS 2009E-2014E

Sales Forecasts of Phase III Developmental MS Drugs
Model Assumptions

ANALYSIS OF PHASE II DRUGS

New Drugs in Early Clinical Development to Treat MS
Disease-modifying Agents
ATL1102/TV1102
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
CDP323
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
  Daclizumab
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Firategrast
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
    Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Ibudilast
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Vaccines
BHT-3009
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecast and assumptions
  Competitor ratio analysis
NeuroVax
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis
Tovaxin
  Novelty/rationale for mechanism of action
  Proof of concept/clinical data
  Management/clinical expertise
  Competition within the market-place/gaining share of voice
  Risks associated with developing a drug within a therapeutic class
  Filings and approval
  Sales forecasts and assumptions
  Competitor ratio analysis

GLOBAL SALES FORECASTS OF PHASE II MS DRUGS 2011E - 2014E

Sales Forecasts of Phase II Developmental MS Drugs
Model Assumptions

CO MPETITOR RATIO ANALYSIS

COMPETITOR RATIO ANALYSIS - PRODUCTS

CR Analysis of MS Agents Approved by 2014 - Based on Drug Class

COMPETITOR RATIO ANALYSIS - COMPANIES

CR Analysis of MS Agents Approved by 2014 - Based on Company

WINNERS & LOSERS

Summary of Key Companies and Drugs in the MS Market by 2014

DISCO NTI NUATIO N OF DRU GS

MS Drugs Discontinued from Clinical Development

MS APPE NDIX 1

Clinical Diagnostic Test for MS

MS APPE NDIX 2

Expanded Disability Status Scale (EDSS)

MS APPE NDIX 3

Phase Transition Probability
Probability of Launch

MS APPE NDIX 4

MS Patient Model
Summary of US MS Patient Population Forecasts
Summary of Europe (Top 5) MS Patient Population Forecasts
Summary of Japan MS Patient Population Forecasts

MS APPE NDIX 5

Global MS Drugs Sales 2007A-2014E
Global MS Drug Sales 2007A-2014E

MS APPE NDIX 6

Competitor Ratio Analysis Criteria
Key MS Drugs on the Market by 2014

MS GLO SSARY

MS RE FERE NCE S

ACRO NYMNS
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