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Actelion gets “best case” results from trial of PAH drug

ZURICH/LONDON (Reuters) – A new drug for pulmonary artery hypertension (PAH) from Actelion beat expectations in a key phase III trial. Actelion is banking on macitentan to replace Tracleer (bosentan), which treats the same condition. Tracleer goes off patent from 2015 and also faces growing competition from Gilead’s Letairis (ambrisentan).

Results of the phase III SERAPHIN trial were better than many had expected, reassuring doubters that Actelion – essentially a one-drug company until now – will not see its business fizzle away.

In the study, macitentan decreased the risk of morbidity and mortality in comparison to a placebo by 45% in those patients given 10 mg of the drug and by 30% in those on 3 mg, Actelion said.

Importantly, there was no sign of potential liver problems associated with the drug, putting macitentan at an advantage over Tracleer and in line with Letairis as a treatment for PAH.

“I am extremely pleased with the outstanding SERAPHIN results,” said Chief Executive Officer Jean-Paul Clozel. “We are committed to working with the health authorities to bring this potentially important advancement in PAH to patients as soon as possible.”

Last year, Actelion became embroiled in a boardroom battle with activist investor, Elliott Advisors, a New York-based hedge fund, that urged the company to put itself up for sale.

Actelion, founded by former Roche scientists Clozel and his wife Martine in 1997, saw off that challenge from Elliott. But analysts have continued to speculate the company could be a takeover target once macitentan’s potential became clear.