Cause of deaths unclear in Actelion drug trial
ZURICH (Reuters) - Swiss biotech group Actelion Ltd said it does not yet know what caused the deaths of 120 people on a late-stage trial for heart and lung drug macitentan, a candidate to treat pulmonary arterial hypertension.
"PAH is a deadly disease, therefore it is to be expected that people die," spokesman Roland Haefeli said. "We did expect and observe deaths. Until the (encrypted trial data) code is broken, we do not know (the cause)."
Just over 740 people were on the trial, Haefeli said.
Actelion shares tumbled 9 percent after a report by Bloomberg that the chief executive had said on a conference call it was very unlikely the trial would show the drug extended life.
"The stock has taken a nosedive on what appears to be a misinterpretation around CEO comments regarding the all-important SERAPHIN trial. Nothing negative was said, and we still wait for the data Q2 2012. Expect the stock to recover," one analyst said.
At 1453 GMT, the shares were trading down 3.3 percent, in line with where they had been before the report and after they posted a full-year net loss earlier in the morning.
The primary goal of the phase III trial is to show a significant reduction of both morbidity and mortality in patients with symptomatic PAH.
Actelion still does not have the results of the trial and so cannot yet say if the drug will help patients to live longer without their disease getting worse or even stop people from dying from it. The results are expected in the second quarter of this year.
(Reporting by Katie Reid; Editing by Will Waterman)
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