Good news flowed in at
) with the U.S. Food and Drug Administration (FDA) approving
Opsumit 10 mg once daily for the treatment of pulmonary
arterial hypertension (PAH WHO Group I). Actelion stated in its
press release that Opsumit is the only medicine approved to delay
disease progression and reduce the need for PAH hospitalization.
Disease progression includes events like death, initiation of
intravenous or subcutaneous prostanoids, or clinical worsening of
The approval of Opsumit was partly based on data from the
SERAPHIN study. 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. The study also showed a reduction in the risk of PAH
related hospitalization and death by 50% as compared to
The long-term study established the effectiveness of Opsumit
in PAH patients with predominantly WHO Functional Class II-III
symptoms treated for an average of 2 years.
Actelion will launch Opsumit in the U.S. in Nov 2013. Opsumit
is currently under review in the EU and other countries. 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 the first half
of 2014. In addition, Opsumit is being evaluated for the
treatment of glioblastoma (phase I).
We note that an interesting PAH candidate in Actelion's
pipeline is selexipag. The candidate is undergoing phase III
studies. The final results from the study are expected in mid
2014. We believe the Opsumit approval in the U.S. will strengthen
Actelion's cardiovascular portfolio. However, the PAH market
looks extremely competitive with the presence of
) Revatio and
Gilead Sciences Inc.
Actelion carries a Zacks Rank #1 (Strong Buy) while Bayer
carries a Zacks Rank #2 (Buy).
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