Novartis (NVS) recently presented positive data from a pivotal trial studying its drug ACZ885 for the treatment of systemic juvenile idiopathic arthritis (SJIA), the most severe form of arthritis in children.
The late stage trial (n=84) for SJIA met all the primary and secondary endpoints. Around 83.7% of the patients, between the ages 2 and 19 years, dosed with ACZ885 experienced at least a 30% improvement in symptoms versus 9.8% of those on placebo. Moreover, 32.6% of the patients saw a 100% improvement in symptoms against no improvement for those on placebo.
Novartis is also studying ACZ885 in another pivotal trial for the disease. Data from the trial will be presented later in 2011. Regulatory applications are expected to be filed in 2012 based on data from these pivotal trials.
ACZ885 is currently marketed for the treatment of cryopyrin-associated periodic syndromes (CAPS) under the trade name Ilaris. In Japan, however, the drug is under review for this indication.
Besides, ACZ885 is under review for the treatment of patients suffering from severe gouty arthritis, commonly known as gout. Last month, the US Food and Drug Administration (FDA) issued a complete response letter to Novartis for this indication, dissatisfied as it was with the benefit-risk profile in refractory patients and requested more data to evaluate the same. Novartis plans to work closely with the FDA on the issue. Novartis had filed a regulatory application in the US in February 2011. Novartis has also submitted regulatory applications for the candidate in the European Union, Canada and Switzerland.
The company is also looking to expand the use of the candidate and is currently conducting studies for several additional indications. Novartis is studying ACZ885 for type II diabetes in mid-stage trials. Novartis also plans to start a late stage trial in secondary prevention of cardiovascular events.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #3 Rank (“Hold” rating) in the short run. Though pleased with Novartis’ wide range of products and its efforts to diversify further, as is evident by the acquisition of eye-care company Alcon, we prefer to remain on the sidelines due to the imminent patent cliff faced by the company.
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