Actelion Wins EU Panel Backing for Opsumit After FDA Approval

Actelion Ltd. won backing from a European Union advisory panel for its lung drug Opsumit, a week after winning U.S. approval for the same pill.

Opsumit, also known as macitentan, was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of pulmonary arterial hypertension, the agency said in a statement today. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation.

Actelion is trading near a six-year high after winning approval for Opsumit from the U.S. Food and Drug Administration on Oct. 18. Sales of the drug will reach 993.8 million Swiss francs ($1.1 billion) in 2017, according to the average of six analyst estimates compiled by Bloomberg. That will help replace declining revenue for Tracleer, the treatment that accounts for 87 percent of sales and starts losing patent protection in 2015.

Chief Executive Officer Jean-Paul Clozel has bet the future of the company he co-founded on Opsumit, including fighting off a hedge fund that sought seats on the board and wanted the company to consider selling itself in 2011.

Actelion fell 0.2 percent to 69.20 Swiss francs as of 2:47 p.m. in Zurich, giving the company a market value of 8.3 billion francs. The stock has returned 62 percent this year, including reinvested dividends, compared with a 23 percent return for the Bloomberg Europe Pharmaceuticals Index.

Actelion expects the EC to grant marketing authorization for the drug in two months, the company said in a statement today.

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