Actelion braces for looming pivotal data on blockbuster macitentan program

Actelion's ($ATLN) approach to the year ahead might best be described as hoping for the best while preparing for the worst. Crucial late-stage data on macitentan is due to read out in the second quarter of this year, and CEO Jean-Paul Clozel told a Bloomberg interviewer at the J.P. Morgan event that the next-gen successor to the blockbuster Tracleer has "very high" odds for success.

"What is important for us is to do everything in order for the trial to succeed," such as monitoring the quality of data collection, Clozel said, according to the Bloomberg story. "We are working on making this thing work."

Over the past year the Swiss biotech has had to endure challenges from investors and a group of slow-paying Tracleer customers in southern Europe, where the economic crisis has bred a growing stack of unpaid healthcare bills at cash-strapped health systems. All that can be dealt with if macitentan proves a winner in Phase III. But without spelling out the details, Clozel also says the company has been hammering out a Plan B in case the study fails.

"It's our job to say 'What happens if it doesn't work?,'" Clozel said. "We have to be ready. We are preparing some plan B. This is my job and the board's job. All the options will have to be evaluated."

Analysts have been fretting about macitentan's fate for some time now. The experimental drug failed to hit the primary endpoint for idiopathic pulmonary fibrosis in a mid-stage trial last summer, but the study helped build confidence that macitentan can clear safety hurdles on pulmonary arterial hypertension, which is the key market. Tracleer earned more than $1.5 billion last year and an approval for PAH could be worth the same.

- here's the story from Bloomberg

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