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| Actelion CEO Jean-Paul Clozel |
Shares of Switzerland's Actelion ($ATLN) spiked 15% Monday morning after the biotech reported that its next-gen oral pulmonary arterial hypertension (PAH) drug selexipag proved a success in Phase III, setting up a showdown with regulators for a drug that's widely billed as a likely blockbuster.
Investigators recruited more than 1,000 patients for this study, concluding that the therapy reduced the risk of a morbidity/mortality event versus placebo by 39%. PAH is characterized by high blood pressure in lung arteries, which causes life-threatening stress on the heart.
"I am overwhelmed by the result of this long-term outcome study that evaluated selexipag in a setting where 80% of patients already received oral PAH therapy at baseline," said Actelion CEO Jean-Paul Clozel in a statement. "Together with our partner Nippon Shinyaku, we are now one step closer to bringing an effective oral therapy targeting the prostacyclin pathway to the PAH community. We will now work diligently to complete the analyses with the goal to initiate first regulatory filings with health authorities as soon as possible."
Selexipag has been tapped as a potential blockbuster by analysts at Helvea, Barclays and Bank of America Merrill Lynch. Its success in Phase III completes a major turnaround for Actelion, which defied critics last year with the Phase III success and approval of Opsumit as a follow-up to Tracleer, a drug that provides the bulk of its revenue.
"Doctors want a drug of that mechanism that's easier to prescribe and easier to use," Deutsche Bank's Richard Parkes tells Bloomberg. "Selexipag is a truly innovative treatment and there's not really any debate about that."
The news was a blow to United Therapeutics ($UTHR), which stunned investors late last year with the news that the FDA had approved its oral drug Orenitram (treprostinil, or oral Remodulin) after twice snubbing its application. The approval marked a significant step up in market competition. In addition to Remodulin, Actelion's Opsumit competes against Gilead's ($GILD) Letairis, Bayer's Adempas, and Pfizer's ($PFE) Revatio.
- here's the release
- here's the report from Bloomberg