Switzerland-based pharmaceutical company,
) 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
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
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Cushing's disease, which was subsequently withdrawn due to some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).
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.
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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