Product Profiles: Multiple Sclerosis - Gilenya raises bar for new market entrants

Introduction

Beginning with the recent approval of Gilenya (Novartis; fingolimod), MS patients are experiencing the arrival of more effective and less invasive treatment options after numerous years of limited therapeutic options. As competition intensifies, the need for less invasive modes of administration will be met and new drugs will have to compete on other factors, such as efficacy.

Features and benefits

* Understand Datamonitor’s independent appraisal of marketed brands and key pipeline agents indicated for treating multiple sclerosis.
* Illustrate how pipeline and marketed drugs compare to one another in terms of clinical and commercial attributes.
* Assessment of the strengths, weaknesses, opportunities, and threats for key marketed and pipeline therapies.
* Review of important clinical developments for key pipeline agents with analysis of the latest clinical trial data.
* Determine to what extent current and future therapies satisfy the main clinical unmet needs in multiple sclerosis treatment.

Highlights

Datamonitor’s recent survey reveals that US neurologists prescribe Gilenya because of its strong efficacy in treatment resistant patients as well as its convenient oral mode of administration. However, long term cancer and infection risk remain the main concerns.
The multiple sclerosis market has been lucrative for drug companies over the last decade with limited competition and periodic price increases. However, as this dynamic is changing with increased competition, existing players are expanding their portfolios with new and improved therapies.
Monoclonal antibodies have demonstrated potent efficacy in Phase II trials, surpassing all existing therapies. However, excitement is tempered with safety concerns that include risk of malignancy and severe infections. Still, as seen with Tysabri, impressive efficacy may outweigh the risks for more severe multiple sclerosis patients.

Your key questions answered

* How well do agents in late-stage development for multiple sclerosis compare to one another and the current standard of care?
* What is the most promising treatment in development for multiple sclerosis?
* How do US neurologists perceive Gilenya and key pipeline agents as new treatments of multiple sclerosis?
[Studien Infos ausblenden]

Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
MARKET OVERVIEW
Product overview
Datamonitor’s assessment summary
MARKETED PRODUCT PROFILES
Gilenya (fingolimod; Novartis/Mitsubishi Tanabe Pharma)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Physician perception of Gilenya
Clinical and commercial attractiveness
Avonex (interferon beta-1a; Biogen Idec)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Rebif (interferon beta-1a; Merck Serono)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Betaseron (interferon beta-1b; Bayer Schering)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Extavia (interferon beta-1a; Novartis)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Copaxone (glatiramer acetate; Teva)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Tysabri (natalizumab; Biogen Idec/Elan)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Ampyra (dalfampridine; Acorda Therapeutics/Biogen Idec/Elan)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Sativex (nabiximols; GW Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Product positioning
Clinical and commercial attractiveness
Other marketed drugs for multiple sclerosis
Novantrone (mitoxantrone; Merck Serono)
PIPELINE PRODUCT PROFILES
Movectro (cladribine; Merck Serono)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of Movectro
Clinical and commercial attractiveness
Monthly Avonex (PEGylated interferon beta-1a; Biogen Idec)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of monthly Avonex
Clinical and commercial attractiveness
BG-12 (dimethyl fumarate; Biogen Idec)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of BG-12
Clinical and commercial attractiveness
Laquinimod (Teva)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of laquinimod
Clinical and commercial attractiveness
Daclizumab (Biogen Idec/Abbott)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of daclizumab
Clinical and commercial attractiveness
Teriflunomide (HMR1726; Sanofi)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of teriflunomide
Clinical and commercial attractiveness
Lemtrada (alemtuzumab; Genzyme/Bayer Schering)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet needs
Physician perception of Lemtrada
Clinical and commercial attractiveness
Ocrelizumab (R15-2477; Roche/Biogen Idec)
Drug profile
Development overview
SWOT analysis
Physician perception of ocrelizumab
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other drugs in development for multiple sclerosis
Tovaxin (Opexa Therapeutics)
BHT-3009 (Bayhill Therapeutics)
Neurovax (Immune Response BioPharma)
Firategrast (GlaxoSmithKline)
ATL1102 (Isis Pharmaceuticals/Antisense Therapeutics)
BAF312 (Novartis)
Ponesimod (R-3477; Actelion)
ONO-4641 (Ono Pharmaceuticals)
Arzerra (ofatumumab; Genmab/GlaxoSmithKline)
LY2127399 (Eli Lilly)
Pleneva (BGC-20-0134; BTG)
IPX056 (baclofen controlled release; Impax Laboratories)
MCT-125 (lofepramine and L-phenylalanine; Multicell Technologies)
BIBLIOGRAPHY
Journal papers
Websites
Other sources
Datamonitor reports
APPENDIX A
Datamonitor drug assessment scorecard
Physician research methodology
Physician sample breakdown
The survey questionnaire
Introduction
Section 1: Unmet Needs
Section 2: Influencing factors on prescribing
Section 3: New therapies entering Multiple Sclerosis
Demographics
APPENDIX B
Market definition
PharmaVitae Explorer database
Contributing experts
Conferences attended
Report methodology
[Inhaltsverzeichnis ausblenden]