Actelion Ltd. (ALIOF) announced the launch of Opsumit 10 mg in the U.S. for the treatment of patients suffering from pulmonary arterial hypertension (PAH WHO Group I) to delay disease progression. Disease progression includes events like death, commencement of intravenous or subcutaneous prostanoids or clinical worsening of PAH.
The SERAPHIN study established the effectiveness of Opsumit in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013
The approval of the drug in the EU for the PAH indication is also on track. Last month, Actelion received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Opsumit. Actelion is looking to get Opsumit approved in the EU as monotherapy or in combination, for the long-term treatment of PAH in adults of WHO functional class II to III. A final decision on Opsumit should be out by year end. It has also filed for approval in other regions.
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 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 in delaying disease progression over the long term in PAH patients. However, the PAH market looks extremely competitive with the presence of Bayer’s (BAYRY) Adempas, Pfizer Inc.’s (PFE) Revatio and Gilead Sciences Inc.’s (GILD) Letairis.
Actelion carries a Zacks Rank #1 (Strong Buy) while Bayer is a Zacks #2 (Buy) Ranked stock.
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