) recently submitted a New Drug Application (NDA) to the US Food
and Drug Administration (FDA) for the approval of its pulmonary
arterial hypertension (PAH) candidate, macitentan (Opsumit).
Actelion also announced data from its phase III outcome study
on macitentan. The phase III outcome study, SERAPHIN, enrolled
742 patients having PAH. Results from the study revealed that
treatment with macitentan (10mg once daily) reduced the risk of
morbidity and mortality event by 45% compared to placebo. The
risk was reduced by 30% in PAH patients treated with the 3 mg
dosage of the drug.
Data from the study also revealed that the risk of death or
hospitalization due to PAH was 50% and 33% lower for patients in
the 10 mg and 3 mg arms respectively compared to placebo.
Patients in the study were treated for a period of three and a
half years and the candidate was well tolerated among these
patients. Actelion reported that the number of serious adverse
events was lower in patients treated with macitentan than
Actelion currently has three marketed products, Tracleer,
Ventavis and Veletri, for the treatment of PAH. We remind
investors that during the first nine months of 2012 the company
reported a decline in sales in Tracleer and Ventavis from the
year-ago period. Veletri, launched in 2010, however did very well
during the period.
Actelion currently competes with players such as
) in the PAH space. We believe that if macitentan is cleared by
the FDA, then Actelion's position in the PAH market would be
Actelion carries a Zacks #2 Rank (Buy) in the short run.
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