Swiss pharma giant Novartis (NVS) received a shot in the arm with two of its popular drugs receiving regulatory approval in Japan. The Ministry of Health, Labor and Welfare (MHLW) cleared Gilenya for the prevention of relapse and delay in progression of physical disability in adults with multiple sclerosis (MS) and Ilaris for the treatment of cryopyrin-associated periodic syndrome (CAPS) in both adults and children.
Both the drugs are already approved in more than 50 countries including the US, European Union and Switzerland.
Novartis is looking to expand the use of Ilaris and is currently conducting studies for several additional indications. In August the FDA issued a complete response letter to the supplemental new drug application (sNDA) filed requesting approval of Ilaris for the treatment of patients suffering from severe gouty arthritis, commonly known as gout. The FDA requested additional clinical data as it was dissatisfied with the benefit risk profile in refractory patients and requested more data to evaluate the same. Earlier in June, an advisory committee of the FDA, though satisfied with the overall efficacy of Ilaris, did not recommend approval of the drug for the proposed indication. They suggested that the drug should be used in a more narrow population of gouty arthritis patients. Novartis plans to work closely with the FDA on the issue.
Further, Novartis is studying Ilaris 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 soon.
Gilenya’s competing drug is Merck KGaA’s (MKGAF) cladribine whose approval has been delayed by its recent withdrawal of regulatory applications, both in the US and EU, due to the need of an additional trial. In future, Gilenya could face competition from Biogen’s (BIIB) oral multiple sclerosis drug BG-12, which reported positive top-line data in early April 2011 and is expected to be filed in early 2012.
Our Recommendation
Currently, we have a Neutral recommendation on Novartis. 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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