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