Current Use of FDA-Approved Pharmacotherapy for MS-Related Symptoms Is Low, Regardless of the High Need Reported by US Neurologists, According to a Recent BioTrends Report

EXTON, Penn.--(BUSINESS WIRE)-- The prevalence of most multiple sclerosis (MS)-related symptoms tends to increase with disease progression, with walking impairment, fatigue, muscle weakness, and spasticity being the most common symptoms among progressive MS patients. However, they are not necessarily the MS-related symptoms that are most likely to be treated with chronic pharmacotherapy. Since there are currently very few FDA-approved symptomatic agents, the agents most often prescribed to help control MS-related symptoms are typically products without a formal indication for MS. While neurologists believe that the greatest need exists for new therapies targeting cognitive dysfunction and walking impairment in patients with MS — both symptoms which are perceived to have a substantial impact on MS patients’ quality of life — current late stage clinical development focuses predominantly on spasticity management where level of awareness and interest in products tends to be low.

The most recently released report in the TreatmentTrends^®: Multiple Sclerosis series also provides an in-depth analysis of the trial, uptake, perceptions, and promotional presence of two FDA-approved symptomatic agents — Acorda’s Ampyra (for treatment of walking impairment) and Avanir’s Nuedexta (for treatment of pseudobulbar affect). Ampyra share at 9% compared to Nuedexta share at 1% is in line with the higher prevalence of walking impairment versus pseudobulbar affect. However, even with the availability of Ampyra, pharmacotherapy targeting walking impairment remains a high unmet need in the minds of neurologists.

In addition to an in-depth evaluation of symptomatic management in MS, this report continues to track attitudes, perceptions, and prescribing behaviors related to disease-modifying agents (DMAs) used to treat MS. While trial of Novartis’ Gilenya, the first and only oral DMA for the treatment of MS, has increased to 75% at one year post-launch, share has remained relatively flat compared to the previous quarter suggesting that the average volume of Gilenya patients per prescriber may be contracting. Teva’s Copaxone, the market leader with 30% of reported DMA market share, continues to enjoy high levels of success, as indicated by self-reported first line preferences, perceptions around patients’ DMA preference, and overall product satisfaction. Over the next six months, DMA prescribing is anticipated to increase among CIS and progressive MS patients with the newer DMAs, Novartis’ Gilenya and Extavia and Biogen Idec’s Tysabri, continuing to pull share from the more established DMAs. Among the DMAs in development, awareness of and interest in Biogen Idec’s BG-12, Teva’s laquinimod, and Sanofi / Genzyme’s alemtuzumab is high with awareness of BG-12 having increased significantly as a result of the positive Phase III clinical trial data release in October 2011.

TreatmentTrends^®: Multiple Sclerosis is a syndicated quarterly report series that provides a comprehensive view of the current and expected future management of MS based on primary research. The Q4 2011 wave was fielded with 205 neurologists in the U. S. in November 2011. A parallel report covering the European market (EU5) is also available. These reports cover the use of DMAs for the treatment of MS, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth, and expected future use. In addition, respondents are queried about their awareness of and interest in DMAs and MS-related symptomatic products in development.

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