drug meets main goal in late-stage study
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[June 16, 2014]
By Caroline Copley
ZURICH (Reuters) - Actelion
Ltd said its experimental heart and lung drug Selexipag
met its primary goal in a late-stage study, giving the
Swiss biotech company a potential second big seller to
replenish its product pipeline.
Selexipag is the third drug from Actelion to treat pulmonary
arterial hypertension (PAH), a progressively worsening condition
characterised by abnormally high blood pressure in the arteries of
the lungs. The cause is unknown and the disease has no cure. The
positive result is a boost to Europe's biggest biotech company and
should reassure investors that the firm's long-term growth prospects
are on course, after another PAH treatment, Opsumit, won approval in
Europe and the United States.
Both drugs are successors to Actelion's mainstay product Tracleer,
which makes up over 80 percent of sales, and loses patent protection
Shares in Actelion, which have already gained more than 20 percent
so far this year in anticipation of the data, jumped 14.9 percent to
104.5 Swiss francs in early trade.
Deutsche Bank analyst Richard Parkes said the results look like a
"close-to-best case outcome."
"This should allow it to fully offset the Tracleer patent cliff over
2015-17 and adds significant confidence over the longevity of
Actelionís core PAH franchise that was arguably previously still
lacking," Parkes wrote in a note.
Jefferies analysts described the results as "impressive" and said
their original peak sales estimate of $800 million would now likely
Results of the Phase III study involving 1,156 patients found the
drug reduced the risk of a morbidity/mortality event by 39 percent
versus a placebo in patients suffering from PAH.
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Chief Executive Jean-Paul Clozel said in a statement he was
"overwhelmed" by the results, adding Actelion planned to submit
Selexipag for approval with health authorities as soon as possible
once analyses of the study have been completed.
Selexipag, which was originally discovered by Japan's Nippon
Shinyaku, is an oral drug and thus more convenient than some other
treatments that target the prostacyclin pathway that must be inhaled
or administered intravenously.
Actelion said detailed results of the study will be presented at
upcoming congresses and in peer review publications.
(Editing by Sophie Walker)
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