The European Medicines Agency (EMA) recently accepted the
Marketing Authorisation Application (MAA) filed by
) seeking approval for its pulmonary arterial hypertension (PAH)
We note that the marketing application was submitted on the
basis of data from a long-term, pivotal, and event-driven phase
III outcome study (SERAPHIN: n=742). The study evaluated
macitentan at two doses (10 mg and 3mg) in patients suffering
from PAH. Results from the phase III 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 further reported that the number of serious
adverse events was lower in patients treated with macitentan than
We note that macitentan is also under review in the US for the
PAH indication. In October 2012, Actelion submitted a New Drug
Application (NDA) to the US Food and Drug Administration (FDA)
seeking approval of macitentan for the indication. Actelion also
intends to get macitentan approved for PAH in Switzerland and
other major markets across the globe.
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. Actelion's top line would be boosted further
if macitentan is cleared in the US and the EU.
Switzerland-based Actelion carries a Zacks #1 Rank (Strong
Buy) in the short run.
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