In another positive pipeline development, Novartis (NVS) recently announced positive data from two late stage trials of its pipeline candidate ACZ885 for the treatment of patients suffering from severe gouty arthritis, commonly known as gout. The data showed that ACZ885 was more effective in reducing patients’ pain than an injectable steroid used for treating gouty arthritis attacks. ACZ885 also reduced the risk of new attacks by 68% compared to the steroids.
Novartis filed regulatory applications in the EU and US for ACZ885 for the treatment of gouty arthritis in December 2010 and February 2011, respectively. The company has also submitted regulatory applications for the indication in Canada and Switzerland.
Gouty arthritis is the most common form of inflammatory arthritis in adults and affects roughly 1-4% of adults. It leads to severe pain which can last for a week or more. There is significant unmet need for the treatment of gouty arthritis as the currently available options like non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine may be unsuitable for patients who have coexisting medical problems.
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.
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. The company is also studying the candidate for the treatment of systemic juvenile idiopathic arthritis (SJIA), the most severe form of arthritis in children. A late stage trial for SJIA met the primary endpoint and a second pivotal study is currently ongoing. Novartis plans to start a late stage trial in secondary prevention of cardiovascular events in the second quarter of this year.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis. The recommendation is supported by a Zacks #3 Rank (short-term 'Hold' rating). 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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