Data on Novartis' Signifor - Analyst Blog

Novartis NVS presented encouraging results from a pivotal phase III trial on Signifor LAR (SOM230) at the 16th European Congress of Endocrinology.

The study was conducted among patients suffering from acromegaly, a chronic hormonal disorder that occurs when excess growth hormone is produced.

The multicenter phase III study (n=198) was a randomized, double-blind trial which evaluated Signifor LAR 40 mg versus continued open-label treatment with Sandostatin LAR 30 mg or Somatuline Autogel 120 mg.

The data from the study showed that patients taking Signifor long-acting release (LAR) achieved greater disease control when compared to continued treatment with the standard treatment such as Sandostatin LAR.

We note that Novartis is seeking label expansion for Signifor for the treatment of acromegaly.

Signifor is approved in the U.S. and EU for the treatment of adult patients with Cushing's disease.

Based on encouraging results from phase II study and previously published data from other phase III studies, Novartis plans to file Signifor LAR for an additional indication in acromegaly to regulatory bodies.

The label expansion of Signifor for additional indication will boost sales of the drug.

Last week, Novartis received  positive news when the U.S. Food and Drug Administration (FDA) approved Zykadia for the treatment of patients suffering from anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer's PFE Xalkori.

We are encouraged by the recent bout of news at Novartis given the disappointing first quarter results in Apr 2014.