Good news flowed in at Actelion Ltd (ALIOF) with Health Canada approving Opsumit 10 mg once daily for the long-term treatment of pulmonary arterial hypertension (PAH WHO Group I). Opsumit will be used to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenital heart disease.
Results from the SERAPHIN study (n=742) conducted on Opsumit 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.
Actelion will launch Opsumit in Canada in early 2014. 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).
In the last month, the U.S. Food and Drug Administration approved Opsumit 10 mg once daily for the treatment of PAH WHO Group I to delay disease progression. It will be launched in the U.S. shortly. Actelion also received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for Opsumit. Opsumit is currently under review in other countries like Switzerland, Australia, Taiwan, Korea and Mexico.
We note that an interesting PAH candidate in Actelion’s pipeline is selexipag. The candidate is in phase III studies with final results due in mid-2014.
Actelion carries a Zacks Rank #1 (Strong Buy). Currently, companies like Jazz Pharmaceuticals Ltd. (JAZZ), Impax Laboratories Inc. (IPXL) and Bayer (BAYRY) also look attractive. Jazz Pharma and Impax Labs carry a Zacks Rank #1 while Bayercarriesa Zacks Rank #2 (Buy).
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