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Novartis AG recently announced results from two large phase III studies of its multiple sclerosis (MS) drug Gilenya. The company intends to present data from the studies at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The studies evaluated the early and sustained efficacy benefit and long-term safety profile of the drug. Gilenya is the first approved once-daily oral therapy for the treatment of relapsing forms of MS.

Results from the pivotal FREEDOMS (n=1272) and FREEDOMS II (n=1083) studies revealed that early treatment with Gilenya has a significant positive effect on relapses and MRI outcomes, including loss of brain volume, in MS patients. The difference between the drug and placebo was significant by day 82 in FREEDOMS study, whereas the same was observed by day 64 in the FREEDOMS II study.

Novartis also published new data from the PANGAEA observational study. The study is evaluating the efficacy and safety of Gilenya in everyday clinical practice. The overall safety profile as revealed by the study was identical with the previous data.

We note that in June this year, Novartis reported long-term data from an extended phase III head-to-head TRANSFORMS study. Data from the TRANSFORMS study revealed reductions in relapses and MRI measures in patients who shifted from Biogen Idec Inc.’s MS drug Avonex to Gilenya in the extended phase. Data also revealed that the drug was safe and well-tolerated.

Gilenya recorded revenues of $283 million in the second quarter of 2012. Novartis markets Gilenya both in the US and the EU. Notably, a patient died within 24 hours of taking the first dose of Gilenya in November 2011. Consequently, a Drug Safety Communication (DSC) was issued by the FDA in December 2011.

In May 2012, the FDA completed its evaluation of the matter. The regulatory body could not conclude if the drug was responsible for the death of the patient. The FDA is, however, concerned about the cardiovascular effects of Gilenya. As a result, the FDA has advised patients not to take Gilenya in case of certain adverse events.

Our Recommendation

We have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.

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