Novartis (NVS) recently presented new data on Gilenya from a phase III study, TRANSFORMS.
Gilenya is the first approved once-daily oral therapy for the treatment of relapsing forms of multiple sclerosis (MS). It was observed in the study that Gilenya was effective against key measures of disease activity in MS -- brain volume loss, lesion activity, relapse rates and disability progression, both in the short and long run.
Additionally, the study showed that the treatment with Gilenya resulted in approximately 50% more patients being free of MS, after the patients switched from standard interferon treatment.
Further, data from the study demonstrated that treatment with Gilenya can reduce brain volume loss significantly (almost by 50%) compared to standard interferon treatment. It was also observed that the rate of brain volume loss lessened in patients, who switched to Gilenya from standard interferon treatment.
Novartis licensed Gilenya from Mitsubishi Tanabe Pharma Corporation.
We note that Gilenya is approved in the US 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 shows the effectiveness of the drug against standard treatments in the long run along with reinstating the safety and tolerability of the drug.
We note that Gilenya was one of the top selling drugs of Novartis in 2012 with sales of $1.2 billion, up 147% 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 US approval in Mar 2013. EU approval is on the cards as the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Tecfidera in Mar 2013.
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