) 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
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 (
) 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subsequently withdrawn due to some problem in the chemistry,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 (
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.
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
NOVARTIS AG-ADR (
): Free Stock Analysis Report
To read this article on Zacks.com click here.