Actelion ($ATLN) has anxiously been awaiting FDA approval of its new pulmonary arterial hypertension (PAH) treatment Opsumit, a follow-up to its only significant product, Tracleer, which goes off patent in 2015. Friday the Swiss drugmaker got the approval, after markets were closed in Europe. Today its stock moved up 7% on the news.
The FDA approved Opsumit for the treatment of PAH just 10 days after doing the same for Bayer's Adempas, although Adempas also was approved for treating a second form of rare pulmonary disorder. The FDA said that Opsumit will carry a boxed warning like other drugs in its class that it should not be given to pregnant women.
Opsumit hits a fairly crowded market. As well as its own predecessor and the new Adempas, it will also compete with Gilead Sciences' ($GILD) Letairis (ambrisentan), as well as Remodulin from United Therapeutics ($UTHR) and Pfizer's ($PFE) Revatio, which contains the same active ingredient as the erectile dysfunction drug Viagra. Adempas has the advantage of being a pill.
And Tracleer continues to do so well that Actelion yesterday upped its profits on improved 9-month revenue for the drug. Its sales rose 3% to CHF 1.138 billion ($1.26 billion). Those, along with lowered costs, helped raise profits to CHF 105 million to best analysts' forecasts of CHF 88.5 million.
- here's the FDA announcement
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