Swiss pharmaceutical giant
) recently announced mixed data from a phase III study of its
acute heart failure (AHF) candidate RLX030 (serelaxin).
The study met one of its two primary objectives of reducing
dyspnea (shortness of breath) in patients suffering from AHF.
Novartis also reported that RLX030 lessened all-cause and
cardiovascular mortality rate by 37% in patients suffering from
AHF compared to placebo after six months.
The phase III study, however, failed to meet its secondary
objectives of days alive and out of hospital and cardiovascular
death or re-hospitalization due to heart or kidney failure up to
day 60. The second co-primary endpoint was also not achieved.
Novartis is discussing the phase III results with regulatory
authorities around the globe. The company, along with its wholly
owned subsidiary Corthera Inc., has worldwide rights to RLX030
(except in Canada).
Given the mixed data on the candidate, the company could be
required to conduct an additional study depending on the
We note that Novartis has several candidates under development
for the treatment of heart failure. In August this year, the
company announced positive results from a phase II study of
LCZ696, which showed significant reduction in a key indicator of
morbidity and mortality in patients suffering from chronic heart
failure with preserved ejection fraction (HF-PEF). The heart
failure market currently has players like
Takeda Pharmaceutical Company Limited
Merck & Co
Novartis also received encouraging news on its Cushing's
disease candidate Signifor (pasireotide). The Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC) of the US Food and
Drug Administration (FDA) provided a positive opinion on the
candidate to treat patients suffering from Cushing's disease and
who required medical therapeutic intervention.
The advisory panel's support for the candidate was based on
positive data from the phase III PASPORT-CUSHINGS (PASireotide
clinical trial PORTfolio - CUSHING'S disease) study on
We remind investors that in April this year, Signifor was
approved in the EU for the treatment of Cushing's disease.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold rating) in the short
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