Multiple Sclerosis

Pharmacor -- June 2008

  Introduction:

The dynamic, late-stage multiple sclerosis (MS) pipeline is expected to yield nine new therapies over the next decade, including the first orally available drugs formally approved for MS--a major milestone in this market. However, because of lingering concerns about efficacy and/or safety, none of these agents is expected to fully unseat today’s current therapies.

  Questions Answered in This Report:

Oral therapies represent the most highly anticipated near-term treatment advancement in MS for patients and prescribers. An oral drug with adequate efficacy and acceptable safety will achieve significant market success. Which of the five oral therapies expected to launch over the forecast period will be the first to market? Will any oral products become a first-line treatment? Which MS patients are most likely to receive oral therapies? How will five oral drugs, launched closely together, perform in the marketplace?

Natalizumab (Biogen Idec/Elan’s Tysabri) is available in nearly every major market, and no fatal side effects have been reported in the commercial setting. Are neurologists growing more comfortable with natalizumab? How has Tysabri changed the landscape for MS drugs? To what degree will the drug challenge the market success of current and emerging therapies?

Experts have grown increasingly enthusiastic about the monoclonal antibodies alemtuzumab (Bayer Schering/Bayer HealthCare/Genzyme Oncology’s Campath/MabCampath) and rituximab (Biogen Idec/Genentech/Zenyaku Kyogo’s Rituxan, Roche’s MabThera) in MS. However, both drugs carry a risk of potentially serious side effects. How will new monoclonal antibodies fare against natalizumab? Have patients and neurologists grown amenable to risky drugs since natalizumab’s return to market? To which patient segments are neurologists prepared to prescribe such drugs?

Biosimilar versions of the interferon-betas are expected reach the European and U.S. markets in 2011 and 2015, respectively. What development and marketing hurdles will biosimilars face? Will physicians be willing to prescribe biosimilars? To what extent will biosimilars impact the leading branded products?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 43 country-specific interviews with thought leaders, MS specialists, and neurologists.

Epidemiology: Prevalence of relapsing-remitting MS (including clinically isolated syndrome patients); prevalence of chronic progressive MS.

Population segments in market forecast: Relapsing-remitting MS (including clinically isolated syndrome); chronic progressive MS.

 Emerging therapies: Phase II: 19 drugs; Phase III: 8 drugs. Coverage of 26 select preclinical and Phase I products.

Market forecast features: We provide an in-depth examination of current and future MS diagnosis/drug-treatment trends and market performance over a ten-year forecast period (2007-2017). Using a proprietary generic erosion model, we also forecast the effect of biosimilar launches for leading current therapies on the U.S. and European markets through 2017.