Novartis AG (NVS) recently published full results on its oral multiple sclerosis (MS) therapy FTY720 (fingolimod) in the New England Journal of Medicine. These results were from two pivotal phase III studies, TRANSFORMS and FREEDOMS, which demonstrated that FTY720 reduced the risk of confirmed disability progression.

Novartis had initially announced results from these studies in Sep 2009. Combined data from the studies showed significant efficacy in reducing relapses, disability progression and magnetic resonance imaging (MRI) lesions in MS.

The one-year TRANSFORMS study showed that the 0.5 mg and 1.25 mg dosages of FTY720 reduced relapses by 52% and 38%, respectively, compared to interferon beta-1a ? Biogen Idec’s (BIIB) Avonex. The two-year FREEDOMS study showed a 54% and 60% reduction in the relapse rate for the 0.5 mg and 1.25 mg dosages, respectively, compared to placebo.

The FTY720 0.5 mg dose was shown to reduce the risk of 3-month and 6-month confirmed disability progression by 30% and 37% over two years versus placebo in the FREEDOMS study.

As far as the safety profile is concerned, although the rate of infections Incorporatedluding serious infections, was comparable between the treatment groups, a slight increase in lung infections (primarily bronchitis) was observed in the FTY720 arm.

Moreover, although the number of malignancies reported in the two studies was low with comparable rates between the groups, malignancies were reported more frequently with FTY720 compared to the control group in the TRANSFORMS study. However, the opposite was seen in the FREEDOMS study.

Novartis has submitted for approval of the candidate in both the US and the EU in Dec 2009. The company is seeking approval for the 0.50 mg dose with a more favorable benefit-risk profile. Approval on a timely basis could result in the therapy being launched in late 2010/early 2011.

The FTY720 could very well become the first product to be approved in a new therapeutic class called sphingosine-1-phosphate (S1P) receptor modulators. Once launched, FTY720 will compete primarily with Biogen Idec, which is the market leader in MS therapies.

Other currently available MS therapies include Teva’s (TEVA) Copaxone and Pfizer/Serono’s (PFE) Rebif. The MS market is huge and represents significant commercial opportunity – up to 2.5 million people are affected by MS worldwide, according to the company. Being an oral therapy, Novartis’ FTY720 could find quick acceptance once commercialized as the currently available therapies require injection or infusion.

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