) recently announced the receipt of Japan's Ministry of Health,
Labor and Welfare approval for epoprostenol "ACT" for the
treatment of pulmonary arterial hypertension (PAH).
The product is marketed in the US as Veletri. In 2012, it gained
marketing approval in Switzerland as Veletri and in Canada as
Caripul. The candidate is currently under regulatory review in
We are encouraged by Japan's approval of this candidate. We note
that Actelion is progressing with its pipeline. Important
pipeline candidates include ponesimod, Opsumit and cadazolid.
Ponesimod is being evaluated for plaque psoriasis. In Dec 2012,
the company announced positive results from a phase II study for
this indication. Results from the study showed that both doses of
ponesimod (20 mg and 40 mg) achieved statistical significance.
Actelion now plans to initiate a phase III study on ponesimod for
the psoriasis indication.
In Apr 2012, Actelion reported positive results on Opsumit
(macitentan) for the treatment of PAH. Actelion filed for US Food
and Drug Administration (FDA) and European Medicines Agency (EMA)
approval of Opsumit in the fourth quarter of 2012.
Cadazolid, for the treatment of clostridium difficile
associated diarrhea (CDAD), is expected to move into phase III
study in the current year. The decision to advance the candidate
into late-stage development was based on an exploratory phase II
Results showed that the effect of all doses of cadazolid were
either numerically similar or better than Vancocin on primary
endpoints, which included CDAD cure rates as well as sustained
Actelion carries a Zacks Rank #3 (Hold). Currently,
) carry a Zacks Rank #2 (Buy).
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