Early this morning, Novartis AG (NVS) announced that data from a two year late-stage study showed that its oral drug FTY720 (fingolimod) was significantly superior to placebo in reducing relapses and disability progression in patients with relapsing-remitting multiple sclerosis (MS).
The double-blind placebo-controlled study, called FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in Multiple Sclerosis), involved 1,272 patients in 22 countries and assessed the efficacy, safety and tolerability of FTY720. The study revealed that FTY720, which was well tolerated in the study, reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the 1.25 mg dose compared to placebo.
Furthermore, the candidate reduced disability progression by 30% for patients on 0.5 mg and 32% for those on 1.25 mg compared to placebo over the entire duration of the study, thus meeting the primary and secondary endpoints for both the doses, with no significant difference in efficacy.
The incidence of adverse events was much lower in the 0.5 mg dosage. Consequently, the company intends to seek approval for the lower dose of the drug in the US and the European Union at the end of this year. Additionally, all further developments of FTY720 in relapsing forms of the disease will be focused on the 0.5 mg dose.
Once launched, FTY720 will compete primarily with Biogen Idec (BIIB), which is the market leader in therapies to treat MS. Biogen’s leading product is Avonex, which recorded sales of $2,203 million, up 18% from 2008. The company’s other MS product, Tysabri, continued to see an increase in patient growth despite carrying a black-box warning for the risk of progressive multifocal leukoencephalopathy (PML) and other cautionary language.
Biogen is working on consolidating its position in the MS market and has an impressive late-stage pipeline of drugs including Fampridine-SR, which is currently under review by the US Food and Drug Administration (FDA). Besides Fampridine, the company has another interesting MS candidate, BG-12, which is currently undergoing late-stage trials. The other leading candidates in the MS market are Copaxone of Teva Pharmaceutical Industries (TEVA) and Rebif of Pfizer (PFE)/Serono.
However, the market has huge potential as only about 36% of MS patients are currently treated with MS drug, this percentage is expected to increase to 56% by 2014 as new oral MS therapies are launched. MS prevalence rate is higher in women than men. It is the fourth leading cause of disability among American women.
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