) recently presented new data on Gilenya from a phase III study,
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
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
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
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
However, competition is intensifying in the MS market for
Gilenya given the presence of various treatments from
). 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
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look well placed with a Zacks Rank #2 (Buy).
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