Novartis AG
(
NVS
) recently announced new long-term data from an extended phase III
head-to-head TRANSFORMS study, which evaluated its multiple
sclerosis (MS) candidate Gilenya (fingolimod). The data was
presented at the 22nd Annual Meeting of the European Neurological
Society in Czechoslovakia.
Gilenya is the only oral therapy approved treating patients
suffering from relapsing forms of MS. Data from the TRANSFORMS
study revealed reductions in relapses and MRI measures in patients
who shifted from
Biogen Idec Inc.
's (
BIIB
) MS drug Avonex to Gilenya in the extended phase. Data also
revealed that the drug was safe and well-tolerated.
Data further demonstrated that patients continuously treated
with Gilenya for up to 4.5 years experienced sustained reduction in
relapses and rate of brain volume loss. Novartis mentioned that as
of February 2012 approximately 36,000 patients were treated with
Gilenya in clinical trials and in the post-marketing setting.
Novartis is working with the European Medicines Agency (EMA) and
the US Food and Drug Administration (FDA) on the benefit and risk
profile of the drug. 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.
Our Recommendation
Though we are pleased with Novartis' wide range of products and
its efforts to diversify further, we prefer to remain on the
sidelines in the long term. We remain concerned about the patent
expirations of key drugs like Femara and Diovan. Thus, we have a
Neutral recommendation on Novartis. Novartis carries a Zacks #4
Rank (Sell rating) in the short run.
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