Therapy Trends: Multiple Sclerosis

An incisive report and dynamic analyst briefing service delivering insight from the most influential Multiple Sclerosis (MS) Key Opinion Leaders to map the current treatment landscape and analyse future trends.

Multiple Sclerosis: On the cusp of a treatment revolution

The year 2012 will see landmark changes in the treatment of MS. Gilenya, the first novel drug in five years, is to be joined by three new products; BG-12 from Biogen Idec, Sanofi's Aubagio and Genzyme's Lemtrada. These drugs will partially satisfy substantial unmet needs of convenient administration and more efficacious therapy to drive unprecedented market growth.

Driven by in-depth interviews with the world's leading multiple sclerosis KOLs, Therapy Trends: Multiple Sclerosis uncovers how the current treatment landscape will be impacted by significant future events, with particular focus on pipeline therapies and how these will modify the way MS is managed by neurologists in the future.

Drive your strategic decision-making with inside intelligence

Therapy Trends: Multiple Sclerosis disseminates critical opinion and analysis to provide premier research.

• We cut to the heart of market-changing events and eliminate superfluous background information so you can focus on developments of greatest strategic impact and reduce your reaction time
• Our unique thought-leader selection matrix identifies the most influential KOLs in MS to deliver the perspectives vital in giving you a competitive edge, enabling informed decision-making and planning
• Detailed analysis of marketed and pipeline drugs helps you understand the products that will shape the future MS market
• KOL consensus on the future treatment algorithm offers a window into the future changes in medical evidence and clinical practice
• Uncovering KOLs' opinions on unmet needs enables you to identify potential commercial opportunities
• Dynamic report updates evaluate the market impact of key events from KOL perspectives, allowing you to react to significant MS market developments within days of events occurring

Critical questions answered

Our MS KOLs are selected according to their level of engagement and influence within the pharmaceutical industry and their scientific standing. FirstWord's unique KOL scoring system enables identification of KOLs with the greatest knowledge of how MS treatment will evolve and shape the future landscape.

• What are the key unmet needs? There is a high risk, high reward opportunity in the development of a therapy with efficacy for progressive subtypes.
• How will therapies will be positioned against each other in the future of MS treatment? Biogen's new oral therapy BG-12 is expected to usurp the current market leaders and become the first-line therapy of choice.
• How will treatment developments play out in the near future? Biogen's activity in broadening its robust pipeline shows its resolve in maintaining its leading position in MS.
• Is there potential for new players in the lucrative MS market? New entrants are set to capture significant share and cannibalise sales of the leading drugs.
• Where will Sanofi's Lemtrada and Aubagio be positioned in treatment? Pricing and safety will play a large part in determining uptake of this highly effective drug
• How will the launch of biosimilars affect prescribing behavior? Pricing will be a key determinant in positioning and uptake
• How will Novartis's Gilenya be affected by recent safety concerns? Long-term concerns have kept it from being the first line therapy.
• Will the new John Cunningham Virus test encourage earlier adoption of Tysabri? This offers the first example of personalised medicine; a trend that will aid uptake in future.

Key Benefits

• Unmet needs analysis to identify opportunities and address the challenges facing disease management
• Strategic mapping of future treatment algorithms based on KOL insight
• Commercial and clinical analysis of pipeline therapies
• In-depth, dynamic event impact assessments to evaluate current strategies and plans against new conditions
• Align investment and resource planning to future trends
• Know the story driving the trends

Executive Summary

Introduction

Methodology

Current multiple sclerosis marketplace

• Current treatment landscape
  • Multiple sclerosis market definition
  • Current market overview
• Current therapies
  • Cross trial comparisons is not an ideal assessment
• Gilenya (fingolimod; Novartis) trends
  • Gilenya has first oral to market advantage
  • Gilenya raises bar for pipeline therapies entering the market
  • Deaths mar Gilenya's side effect profile and positions drug as a second line
  • Vigilance program is cumbersome and likely to restrict access
  • Gilenya's high price will restrict use
  • Clinical trials in progressive multiple sclerosis ongoing
• Tysabri (natalizumab; Biogen/Elan) trends
  • Tysabri is the most effective approved multiple sclerosis therapy
  • PML fears positions drug as second or later line
  • JCV test will promote use and allay fears
  • Progressive multiple sclerosis trials ongoing for Tysabri
• Copaxone (glatiramer acetate; Teva) trends
  • Copaxone is the leading selling multiple sclerosis therapy
  • Teva fights generic Copaxone applications
• Interferon betas (Avonex, Betaseron, Rebif, Extavia) trends
  • Interferons are the mainstay of multiple sclerosis treatment
  • Needles have evolved to avoid injection site reactions
  • Biosimilar guidelines in place for interferons
• Current treatment algorithm
• Multiple sclerosis unmet needs
  • Unmet need 1: Efficacy for progressive subtypes
  • Unmet need 2: Therapies offering better clinical profiles
  • Unmet need 3: Drugs to halt or repair neuronal damage
  • Unmet need 4: Improving multiple sclerosis induced cognition dysfunction
  • Unmet need 5: Need for improved adherence

Future therapy trends

• BG-12 (dimethyl fumarate; Biogen) trends
  • Impressive efficacy and safety means BG-12 will become the leading multiple sclerosis pill
  • BG-12 will become a first-line therapy and a major threat to Gilenya
  • Unknown tolerability profile could prevent uptake
  • Delay in efficacy and compliance are other barriers for uptake
• Aubagio (teriflunomide; Sanofi/Genzyme) trends
  • Aubagio exhibits strong safety profile but has moderate efficacy
  • Aubagio has potential positioning as a combination therapy
  • Pricing will determine Aubagio's success
• Laquinimod (Teva) trends
  • Phase III efficacy data is disappointing and less than current therapies
  • Compelling disability data suggests role in neuroprotection
  • Safety data and mechanism suits role as an add-on therapy
• Lemtrada (alemtuzumab; Genzyme/Sanofi) trends
  • Lemtrada is one of the most effective pipeline therapies
  • Safety concerns may hamper uptake and reserve Lemtrada as a last-line or induction therapy
  • Sanofi will price Lemtrada in line with current treatments
• Daclizumab HYP (Biogen/Abbott) trends
  • Daclizumab complements Biogen's portfolio with good safety and efficacy
  • Daclizumab positioning will be important for Biogen franchise
• Ocrelizumab (Biogen/Roche) trends
  • Ocrelizumab represents the most advanced B-cell therapy
  • Ocrelizumab is highly effective in reducing relapses
  • Questionable long-term safety overshadows potential uptake
• Future prescribing trends
  • More use of induction therapy in highly relapsing patients
  • Current first-line therapies will have a less prominent role in future treatment
  • Interferons and Copaxone can find a niche as combination therapies
  • Oral therapies will become the leading first- and second-line therapies
  • JCV test will drive earlier use of Tysabri
  • Potent but less safe therapies will remain last line

Future developments in multiple sclerosis

• Constrained pricing environments will reduce market access
• Clinically isolated syndrome will be considered early stage multiple sclerosis in the future
• Trend for earlier diagnosis and treatment will produce better outcomes
• Trend to more symptomatic therapies being developed
• Eventual development of biomarkers will aid treatment
• Better understanding of underlying multiple sclerosis etiology
• Methods to assess treatment failure could be implemented in the future
• More emphasis should be placed on long-term outcome measures

FirstWord multiple sclerosis news analysis

• Positive multiple sclerosis key news events
  • Current therapies
  • Pipeline therapies
  • Company therapies
• Negative multiple sclerosis news
  • Current therapies
  • Pipeline therapies
  • Company therapies

Future of multiple sclerosis diagnosis and treatment

Appendix 1

• KOL biographies
  • KOLs from North America:
  • KOLs from Europe

Appendix 2