) recently presented new data on Gilenya (fingolimod), which
demonstrated that the drug can considerably reduce the rate of
brain volume loss.
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Gilenya is the first approved once-daily oral therapy for the
treatment of relapsing forms of multiple sclerosis (MS). The data
also showed that Gilenya reduced annualized relapse rates across
patients in different age groups.
Results from three large pivotal phase III studies (TRANSFORMS,
FREEDOMS and FREEDOMS II) revealed that Gilenya can significantly
lessen the rate of brain volume loss versus a comparator.
Additionally, new extension data from FREEDOMS II reinforces the
safety profile of Gilenya in patients who were treated up to four
Earlier, in Oct 2012, Novartis presented results from the
FREEDOMS (n=1272) and FREEDOMS II (n=1083) studies. These studies
revealed that early treatment with Gilenya has a significant
positive effect on relapses and magnetic resonance imaging 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.
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), which is also known as
rapidly evolving severe RRMS.
Novartis licensed Gilenya from Mitsubishi Tanabe Pharma
Corporation. Gilenya is currently approved in over 65 countries
around the world.
Gilenya recorded $349 million of sales in the fourth quarter of
2012, up 74% from the year-ago quarter. For 2012, sales touched
$1.2 billion, up 147% from 2011.
Hence, we are encouraged by the new data presented on Gilenya,
which should bolster growth for Novartis.
Right now, Novartis carries a Zacks Rank #3 (Hold). Pharma
stocks, which currently look more attractive include
Furiex Pharmaceuticals Inc.
) all with a Zacks Rank #2 (Buy).