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Actelion's Opsumit Cleared in the U.S.

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Good news flowed in at Actelion Ltd. 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 PAH.

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 placebo.

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  Bayer’s (BAYRY - Free Report) Adempas, Pfizer Inc.’s (PFE - Free Report) Revatio and Gilead Sciences Inc.’s (GILD - Free Report) Letairis.

Actelion carries a Zacks Rank #1 (Strong Buy) while Bayer carries a Zacks Rank #2 (Buy).

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