Blockbuster data: Studies back efficacy of late-stage MS pills

A trio of new studies has underscored both the distinct therapeutic advantages as well as the blockbuster market potential of two new oral drugs for multiple sclerosis. But while the studies demonstrated a reduction in the number of relapses and a slowing of disease progression--while beating an established interferon therapy after 12 months of treatment--the drugs' ability to suppress the human immune system also triggered a higher rate of infections.

The news in the NEJM articles was a clear plus for Novartis and Merck KGaA, which have both been advancing oral MS drugs through the pipeline. Novartis recently applied for approval of FTY720 in Europe and the U.S. Merck KGaA, meanwhile, recently ran into an unexpected hurdle at the FDA when regulators handed back its application for cladribine, calling it incomplete and delaying any U.S. launch. That leaves Novartis clearly in the lead for a groundbreaking approval.

The results "provide a new horizon for patients with relapsing-remitting multiple sclerosis and a welcome increase in the range of treatment options," neurologist William Carroll wrote in the New England Journal of Medicine.

Novartis' chief of global drug development told Bloomberg that the sales of FTY720 could "absolutely" surge past the billion-dollar mark to achieve blockbuster status. The drug, he added, is a "potentially game-changing therapy." 

While news of the higher infection rate may spur some caution around the drugs, analysts also note that Tysabri has been very successful in the MS market despite several deaths linked to a rare brain infection. That demonstrates that patients are willing to accept considerable risk when the therapy helps them to manage the disease.

- here's the article from Bloomberg