Switzerland-based pharmaceutical company
) recently announced positive results on Ilaris (ACZ885,
canakinumab). The candidate is being evaluated in a phase III study
for systemic juvenile idiopathic arthritis (SJIA) and a phase II
study for TNF-receptor associated periodic syndrome (TRAPS).
Results from both studies will be presented at the 2012 Congress
of the European League Against Rheumatism (EULAR) on June 7,
Data on Ilaris was reported from a pivotal phase III study,
which enrolled 177 patients with active SJIA. The study was
conducted in two parts. While the first part was an open-label,
single-arm study with Ilaris, the second part of the study was a
randomized, double-blind and placebo-controlled.
At the end of the second part of the study, it was found that
62% of the patients receiving Ilaris had inactive SJIA status as
compared to 32% in the placebo arm. Novartis is preparing to file
marketing applications for this indication.
Meanwhile, data from an ongoing open label phase II study
evaluating Ilaris for TRAPS was also reported. In the study, 20
patients with active TRAPS were enrolled. It was observed that 90%
of the patients experienced a significant improvement in disease
symptoms at the end of one week of treatment. Complete or almost
complete response was observed in 95% of the patients at the end of
the second week of treatment.
Ilaris is already approved for the treatment of patients with
cryopyrin-associated periodic syndromes (CAPS). Apart from SJIA and
TRAPS, the drug is being studied for other indications such as
gouty arthritis and cardiovascular disease.
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. The company carries a Zacks #4
Rank (Sell rating) in the short run.
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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