Overview
MS Injectibles/Infusibles
Alemtuzumab (Campath)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
PEG-Interferon
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Daclizumab
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
MBP8298 (Dirucotide)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Rituxiamb / Ocrelizumab
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
BHT3009
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Tovaxin
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Biogenerics
---- Generic Betaseron (Extavia; Interferon-beta-1b)
---- Generic Copaxone
---- Generic Rebif and Avonex (Interferon-beta-1a)
Conclusions: Injectible or Infusible Agents in Development
Neurologists’ Perspectives
Patients’ Perspectives
Other Injectible Agents in Development
References
Table 1: Overview of Trials
Table 2: Safety and Tolerability
Table 3: Mechanisms of Action and Other Indications

This report analyzes injectible or infusible medications for multiple sclerosis that are in later stage development. These compounds have potential for FDA approval between 2011 and 2015. To be included in this report, a compound must have completed at least one Phase II study with results demonstrating some efficacy for MS.

For each compound, the report includes an overview, mechanism of action, early data, detailed review of the most recent Phase II studies, analysis of efficacy, analysis of tolerability, analysis of safety and calendar. Comparisons to existing therapies and consideration of roadblocks to FDA approval are presented. Additional, attitudes derived from conversations with more than 20 neurologists who manage a total of more than 8000 MS patients and from personal interactions with more than 350 MS patients are incorporated into the opinions.

Overview
MS Injectibles/Infusibles
Alemtuzumab (Campath)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
PEG-Interferon
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Daclizumab
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
MBP8298 (Dirucotide)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Rituxiamb / Ocrelizumab
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
BHT3009
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Tovaxin
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Biogenerics
---- Generic Betaseron (Extavia; Interferon-beta-1b)
---- Generic Copaxone
---- Generic Rebif and Avonex (Interferon-beta-1a)
Conclusions: Injectible or Infusible Agents in Development
Neurologists’ Perspectives
Patients’ Perspectives
Other Injectible Agents in Development
References
Table 1: Overview of Trials
Table 2: Safety and Tolerability
Table 3: Mechanisms of Action and Other Indications

Critical Need for an Oral Multiple Sclerosis Agent
Cladribine
---- Overview and mechanism of action
---- Clinical Studies
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
FTY-720 (Fingolimod)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Teriflunomide
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Laquinimod
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
BG-12
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Oral Medications Conclusions
Apparent Ranking of Agents
Neurologists’ Perspectives
---- MS in the US
---- Switching Agents
---- Restarting Treatment
---- Initiating Therapy
Patients’ Perspectives
Marketing
Other Oral Agents in Development
Other Factors
References
Table 1: Overview of Trials
Table 2: Safety and Tolerability
Table 3: Mechanisms of Action and Other Indications

This report presents a critical analysis of the five oral compounds that are furthest along the regulatory pathway for the treatment of Multiple Sclerosis. These compounds have potential for FDA approval between 2010 and 2013.

For each compound, the report includes an overview of early data, detailed review of the most recent Phase II or Phase III studies, analysis of efficacy, analysis of tolerability, analysis of safety and calendar. Comparisons to existing therapies and consideration of roadblocks to FDA approval are presented.

Additional attitudes derived from conversations with more than 20 neurologists who manage a total of more than 8000 MS patients and from personal interactions with more than 350 MS patients are incorporated into the opinions.

Critical Need for an Oral Multiple Sclerosis Agent
Cladribine
---- Overview and mechanism of action
---- Clinical Studies
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
FTY-720 (Fingolimod)
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Teriflunomide
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Laquinimod
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
BG-12
---- Overview and mechanism of action
---- Study results
---- Analysis of Efficacy
---- Analysis of Tolerability and Ease of Use
---- Analysis of Safety
---- Calendar
---- Summary
Oral Medications Conclusions
Apparent Ranking of Agents
Neurologists’ Perspectives
---- MS in the US
---- Switching Agents
---- Restarting Treatment
---- Initiating Therapy
Patients’ Perspectives
Marketing
Other Oral Agents in Development
Other Factors
References
Table 1: Overview of Trials
Table 2: Safety and Tolerability
Table 3: Mechanisms of Action and Other Indications