Actelion cleared a crucial hurdle today, reporting that its late-stage study of macitentan for pulmonary arterial hypertension beat the primary endpoint. The data clears a path to the regulatory agencies, signaling to investors that the Swiss company can be ready for the loss of patent protection on its primary earner with the introduction of another blockbuster. And Actelion shares ($ATLN) jumped more than 20% on the news.
News of the positive Phase III provides a clean win for founding CEO Jean-Paul Clozel, who has had to fend off repeated claims that the company was on the road to ruin. Actelion gets 90% of its revenue from Tracleer, which loses patent protection in 2015. If macitentan--a successor to Tracleer--can clear a regulatory review, the drug can replace lost revenue.
According to investigators, a 10 mg dose of macitentan reduced the risk of mortality and morbidity 45% compared with a placebo, while the 3 mg dose cut the same risks 30%. It managed those results without evidence of liver toxicity, giving it an edge on Tracleer. And in this heated M&A environment, the promising Phase III quickly triggered fresh speculation of a possible buyout.
"The results of SERAPHIN suggest the market's assumption that its business will simply disappear has been overly negative and are likely to make chances the company becomes an M&A target realistic," noted Richard Parkes, an analyst at Deutsche Bank, according to a Reuters report.
"Essentially 'best case' Phase III results for macitentan should ensure a long-term future for Actelion's PAH franchise and shift the disease treatment paradigm," noted Jefferies.
- read the press release
- here's the Reuters article