Actelion Ltd. had a very successful 2013 driven by the approval of Opsumit in the U.S. and EU in Oct 2013 and Dec 2013 respectively.
Tracleer (pulmonary arterial hypertension (PAH)), the significant revenue contributor, loses patent protection in the 2015-2017 timeframe. With an objective to replace the lost revenues from Tracleer once generics available, the company decided to develop Opsumit and selexipag. Selexipag is undergoing phase III development.
Opsumit 10 mg once daily is approved for the treatment of PAH WHO Group I to delay disease progression. Opsumit is available in the U.S. since Nov 2013 and its first EU launch is planned for Germany in Feb 2014. Actelion will launch Opsumit in Canada in early 2014.
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 reduced 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 believe the launch of Opsumit in the U.S. will strengthen Actelion’s cardiovascular portfolio. Opsumit is the first drug to have proved its efficacy for delaying disease progression over the long term in PAH patients.
Actelion saw another product approval from the U.S. Food and Drug Administration (FDA) this year. Valchlor was approved in the U.S. in Aug 2013 for the treatment of patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). The drug has been approved for treating patients who have previously undergone skin-directed treatment. It is available in the U.S. since Nov 2013.
With the launch of new products, we expect the company to perform well in 2014. Actelion currently carries a Zacks Rank #3 (Hold). Investors may consider companies like Jazz Pharmaceuticals , Lannett Co., Inc. and WuXi PharmaTech (Cayman) Inc. . All these stocks carry a Zacks Rank #1 (Strong Buy).