Actelion Ltd. announced that its pulmonary arterial hypertension (PAH) drug, Opsumit, has been approved in the Switzerland. The Swiss regulatory body, SwissMedic, approved Opsumit for reducing morbidity and the risk of mortality in PAH patients with WHO Functional class II to III.
Opsumit gained approval on the basis of encouraging data from the SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) study (n = 742). Results from the SERAPHIN study showed that the risk of a morbidity/mortality event was cut by 45% in patients who were administered Opsumit 10 mg compared to the placebo arm.
We note that Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013 for the treatment of PAH. The drug contributed CHF5 million to Actelion’s total revenues in the final quarter of 2013 following its launch in Nov 2013. The company said that the drug was well received by the prescribers in the U.S. Opsumit has been seeing strong demand since its launch.
The drug has also received approval in the EU (Dec 2013), Canada (Nov 2013) and Australia (Feb 2014). In Jan 2014, the company launched Opsumit in Canada and Germany. Actelion is looking to get Opsumit approved in other countries as well. The company expects peak sales of Opsumit to even exceed Tracleer sales, a blockbuster PAH drug at Actelion.
Meanwhile, Actelion is working on strengthening it’s PAH franchise and developing another PAH drug, selexipag. Selexipag is currently being evaluated in the phase III GRIPHON study (n = 1,156). Data from the GRIPHON study are expected to be released in mid 2014.
Actelion, a biopharmaceutical company, carries a Zacks Rank #1 (Strong Buy). Investors may also consider other biopharmaceutical companies like Emergent BioSolutions, Inc. (EBS - Free Report) , Gentium and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , all of which carry the same rank as Actelion.