Encouraging Data on Novartis' Gilenya

Novartis (NVS) multiple sclerosis (MS) drug Gilenya continues to show its efficacy in treating patients in the long run. Gilenya is the first approved once-daily oral therapy for the treatment of relapsing forms of MS.

Novartis presented new data on Gilenya from three pivotal studies TRANSFORMS, FREEDOMS and FREEDOMS extension studies. The data indicates that continued treatment with Gilenya can lead to a reduction in brain volume loss in patients suffering from relapsing forms of MS.

It was also observed that a higher proportion of patients treated with Gilenya remained free from disability progression.

Novartis presented this new data at the European Committee for Treatment and Research in Multiple Sclerosis in Denmark.

In addition, Novartis also released data from an international MS registry and a U.S. health claims data base which showed that Gilenya was more effective in reducing risks of relapses compared to standard therapies.

Novartis licensed Gilenya from Mitsubishi Tanabe Pharma Corporation. We note that Gilenya is approved in the U.S. for relapsing forms of MS. In the EU, Gilenya is approved for adult patients with highly active relapsing-remitting MS (RRMS).

We are encouraged by the data on Gilenya, which showed the effectiveness of the drug against standard treatments in the long run. We note that Gilenya was one of the top selling drugs of Novartis in the first half of 2013 generating sales of $889 million, up 68% year over year.

However, competition is intensifying in the MS market for Gilenya given the presence of various treatments from Biogen Idec (BIIB).

Biogen is the market leader in therapies for the treatment of MS with key drugs such as Avonex and Tysabri. Moreover, Biogen received a huge boost recently with its oral MS treatment, Tecfidera, gaining U.S. approval in Mar 2013. Tecfidera is currently under review in the EU.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Allergan (AGN) and Bayer (BAYRY) look well placed with a Zacks Rank #2 (Buy).

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Encouraging Data on Novartis' Gilenya