Switzerland-based pharmaceutical company, Novartis AG (NVS) announced positive results from a phase III study of pasireotide (SOM230) long-acting release (:LAR). Results from the trial were presented at the joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting (ICE/ECE).
The randomized, double-blind phase III study, PASPORT-ACROMEGALY (PASireotide clinical trial PORTfolio - ACROMEGALY), compared the efficacy and safety of pasireotide LAR with Sandostatin LAR (octreotide/IM injection) in 358 treatment naïve patients with active acromegaly. We note that Sandostatin LAR is the current standard of care for acromegaly patients.
The study achieved its primary endpoint as full control of disease was experienced by more patients receiving pasireotide LAR (31.3%) as compared to patients receiving Sandostatin LAR (19.2%).
Pasireotide is currently approved in the E.U. under the trade name, Signifor, for the treatment of adult Cushing's disease patients who are ineligible for surgery or for whom surgery has failed.
As far as the regulatory status in the U.S. 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concerned, Novartis had filed a new drug application (:NDA) in June 2011 for Cushing's disease, which was subsequently withdrawn due to some problem in the chemistry, manufacturing and controls (CMC) section.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 U.S. Food and Drug Administration (:FDA).
Our Recommendation
Though we are 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 patent expirations of key drugs like Femara and Diovan. Thus, we have a Neutral recommendation on Novartis.
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