Switzerland-based pharmaceutical company Novartis AG (NVS) 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, 2012.
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.
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. The company carries a Zacks #4 Rank (Sell rating) in the short run.
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