Actelion Ltd. (ALIOF) announced the launch of Opsumit 10 mg in Germany for the long-term treatment of patients suffering from pulmonary arterial hypertension (PAH WHO Functional Class II to III) to delay disease progression.
Opsumit was approved in the EU in Dec 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.
We note that Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013 and the drug was launched in Nov 2013. Health Canada also approved this drug in Nov 2013.
We note that Actelion is also evaluating Opsumit for additional indications. Opsumit is being evaluated for the treatment of glioblastoma (phase I). It 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 continue as planned.
The launch of Opsumit in Germany marks its first EU launch. In Europe, Opsumit is the first and only PAH drug to have proved its long-term efficacy in PAH patients. The approval of this drug has strengthened Actelion’s cardiovascular portfolio.
Actelion carries a Zacks Rank #1 (Strong Buy). Investors may also consider companies like Lannett Company, Inc. (LCI), Endocyte Inc. (ECYT) and Forest Laboratories Inc. (FRX), all of which carry a comparable Zacks Rank #1.
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