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EU Approves Actelion's Opsumit

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Actelion Ltd. received positive news with Opsumit receiving approval as monotherapy or in combination with another PAH therapy in the EU for the long-term treatment of patients suffering from pulmonary arterial hypertension (PAH WHO Functional Class II to III) to delay disease progression. The first EU launch is planned for Germany in Feb 2014.

The approval did not come as a surprise as Actelion received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Opsumit in Oct 2013.

The approval was based on data from the SERAPHIN study. Results from the SERAPHIN study 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%.

We note that Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013 and it was launched in Nov 2013. Health Canada approved Opsumit in Nov 2013..

The approval of Opsumit has strengthened Actelion’s cardiovascular portfolio.  However, the PAH market looks extremely competitive with the presence of Adempas, Revatio and Letairis.

We note that Opsumit is being evaluated for the treatment of glioblastoma (phase I). Opsumit is also being evaluated in a pivotal phase III DUAL program in patients suffering from digital ulcers associated with systemic sclerosis. The independent Data Monitoring Committee (DMC) has recommended the termination of the phase III DUAL-2 study as it feels a positive primary outcome measure is not likely to result from additional data. However, the DUAL-1 study will be continued as planned.

Actelion carries a Zacks Rank #1 (Strong Buy). Investors may also consider companies like Enanta Pharmaceuticals, Inc. (ENTA - Free Report) , Jazz Pharmaceuticals (JAZZ - Free Report) and Questcor Pharmaceuticals Inc. all of which carry a comparable Zacks Rank #1.

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