Positive Data on Novartis' Signifor - Analyst Blog


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Recently, Novartis ( NVS ) announced that data from a late-stage trial on Signifor (SOM230, pasireotide) was published in the New England Journal of Medicine. The phase III trial data evaluated Signifor in patients suffering from Cushing's disease. Results from this study were first announced on September 22, 2010.

The PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) study was conducted to evaluate the safety and efficacy of Signifor in 162 patients with recurrent Cushing's disease, and newly diagnosed patients with Cushing's disease patients for whom surgery is not recommended.

The trial data demonstrated that after six months of treatment with Signifor, patients experienced lower urinary free cortisol (UFC) levels, a measure of disease control. Approximately 26.3% and 14.6% of the patients reported normal UFC levels after taking 900 ug and 600 ug dose, respectively, of the drug twice daily for six months. The effect of the drug continued even after 12 months of treatment.

Signifor is currently under review in the EU. Earlier this year, Signifor received a positive opinion for the treatment of Cushing's disease from the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency (EMA). As far as the regulatory status in the US is concerned, Novartis had filed a new drug application (NDA) in June 2011 for Cushing's disease, which was subsequently withdrawn due to some problem in the chemistry, manufacturing and controls ( CMC ) section.

The NDA will be resubmitted following discussions with the FDA. Other than Cushing's disease, Signifor is in phase III studies for the treatment of acromegaly and carcinoid syndrome with regulatory filings expected in 2012 and 2013, respectively.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis. The company carries a Zacks #4 Rank ("Sell" rating) in the short run. Though pleased with Novartis' wide range of products and its efforts to diversify further, we prefer to remain on the sidelines in the long term due to the imminent patent cliff faced by the company.

NOVARTIS AG-ADR ( NVS ): Free Stock Analysis Report
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