Actelion Ltd. (
recently announced the presentation of new data on pipeline
candidate, Opsumit, from a pivotal phase III study, SERAPHIN
(Study with an Endothelin Receptor Antagonist in Pulmonary
arterial Hypertension to Improve cliNical outcome), at the
European Society of Cardiology.
We note that Actelion is looking to get Opsumit approved for
the treatment of patients suffering from pulmonary arterial
hypertension (PAH). Opsumit is currently under review in the
U.S., EU and other countries.
Results from the SERAPHIN study (n=742) showed that the risk
of a morbidity/mortality event was cut by 45% in patients who
were administered Opsumit compared to those on placebo.
Over a period of 12 months, Opsumit showed sustained long-term
improvements in 6MWD (6-minute walk distance) versus placebo.
Data reflected no connection between changes in exercise capacity
and long-term outcomes.
Opsumit treated PAH patients in the SERAPHIN study showed
improved hemodynamics parameters. Additionally, consistent
improvements were seen in pulmonary vascular resistance (PVR) and
cardiac index (CI) irrespective of background PAH therapy or
baseline WHO functional class.
Apart from PAH, Opsumit is also being evaluated in a pivotal
phase III program in patients suffering from digital ulcers
associated with systemic sclerosis. Results from this study are
expected in 2014. In addition, Opsumit is being evaluated for the
treatment of glioblastoma (phase I).
Actelion currently carries a Zacks Rank #1 (Strong Buy). Other
stocks that look attractive in the pharma space include
Biogen Idec Inc
. All three carry a Zacks Rank #1.
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