Novartis (NVS) recently announced that a late-stage trial evaluating its pipeline candidate, ACZ885, for the treatment of children with active systemic juvenile idiopathic arthritis (SJIA) met the two primary endpoints.
The data revealed that within 28 weeks of treatment with ACZ885, 45% of the children were able to reduce their use of steroids. Additionally only 27% of patients being given ACZ885 suffered a new flare versus 75% of those on placebo. Data from this study as well as from another ongoing late-stage pivotal study is expected to be used to file global regulatory applications for the indication in 2012.
ACZ885 is currently marketed in many countries for the treatment of cryopyrin-associated periodic syndromes (CAPS) under the trade name Ilaris.
The company is also looking to expand the use of the candidate and is currently conducting studies for several additional indications. In August this year, the US Food and Drug Administration (FDA) issued a complete response letter to the Swiss pharma giant requesting additional clinical data on ACZ885 indicated for the treatment of patients suffering from severe gouty arthritis, commonly known as gout. Novartis had filed a regulatory application in the US for the indication in February 2011. The FDA was dissatisfied with the benefit risk profile in refractory patients and requested more data to evaluate the same. Novartis has also submitted regulatory applications for the candidate in the European Union, Canada and Switzerland.
Novartis is also studying ACZ885 for diabetes as well as 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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