Novartis: FTY720 Offers Gold Standard MS Potential

Phase II trial results have already highlighted the potential of Novartis’ oral multiple sclerosis drug FTY720. Assuming that phase III results confirm this efficacy data, the drug candidate has the potential to dominate the MS market over the longer-term. Indeed, upon approval in 2010, Datamonitor forecasts FTY720 to generate revenues of $338 million, growing to $1.1 billion in 2014.

Multiple sclerosis (MS) is characterized by significant unmet need, with no cure currently available. Treatments are used to modify the disease’s course, treat exacerbations, and manage symptoms. However, most patients still suffer from some attacks and subsequent disability. Furthermore, the efficacy of currently approved MS agents tends to diminish over time and the American Academy of Neurology (AAN) estimates that 35-50% of MS patients do not have an optimal response and, therefore, may benefit from alternative therapies.

Novartis’ FTY720 was highlighted for particular attention after the once-daily, oral agent demonstrated a 55% reduction in relapse rates and an 80% reduction in lesions compared to placebo after six months.

The potential market opportunity awaiting new MS agents has increased following the market withdrawal of Tysabri. Although the FDA recently ruled that Biogen Idec and Elan can resume clinical trials of Tysabri, questions still surround the drug and its future role in the treatment of MS.

FTY720 also stands to gain as a result of its delivery method. With a superior administration profile compared to currently injectable MS agents, Datamonitor expects oral pipeline agents to gain significant market share upon their approval. Use of beta-interferon agents for the treatment of relapsing-remitting MS (RRMS) will decline sharply upon the approval of oral MS formulations, with oral MS agents accounting for 43% of the RRMS market by 2014.

FTY720 is the most promising of the five oral MS agents currently in the late stages of development, some of which may yet struggle with significant regulatory and development hurdles. In addition, where data is available, efficacy associated with all other oral MS agents in development have thus far been inferior compared to phase II FTY720 results.

Providing that data from the phase III trials, scheduled to start in early 2006, are comparable to those shown in phase II, FTY720 is set to become the preferred front-line agent for the treatment of RRMS post-approval in 2010. Datamonitor forecasts FTY720 revenues in RRMS of $338 million in 2010, growing to $936 million in 2012 and $1.1 billion in 2014.

For more information on this and similar research, please contact Datamonitor at +1 212 652 5335 or visit www.datamonitor.com/healthcare