* Macitentan the big hope as Tracleer nears patent expiry
* Drug improved 6-minute walking distance by 23 metres
* Reduced the risk of all-cause mortality by 36 pct
* Halved risk of death and hospitalisation due to PAH
(Adds details on study, analyst)
By Caroline Copley
ZURICH, Oct 24 A new lung and heart drug from
Actelion prolonged overall survival by more than a
third in a clinical trial, reassuring Europe's leading biotech
company that it has a viable successor to its current top
The Swiss company is banking on macitentan to replace
Tracleer, which also treats pulmonary arterial hypertension
(PAH) and currently accounts for around 90 percent of group
sales. Tracleer goes off patent from 2015 and faces growing
competition from Gilead's Letairis.
The latest data presented at a meeting of the American
College of Chest Physicians in Atlanta late on Tuesday showed
that a 10 milligram dose of the drug reduced the overall death
rate by 36 percent.
Macitentan also halved the risk of death or hospitalisation
due to PAH for patients on a 10 mg dose compared to a placebo.
ZKB analysts said the data should help convince doctors to
switch patients onto macitentan from Tracleer.
Pulmonary arterial hypertension (PAH) is a progressively
worsening condition in which the arteries carrying blood to the
lungs narrow, overburdening the heart and raising blood
pressure. The cause is unknown and the disease has no cure.
Actelion said this week it had filed macitentan - which it
plans to sell under the brand name Opsumit - for U.S. regulatory
approval. If the Food and Drug Administration grants the drug a
priority review, a decision could be reached within eight
months, spokesman Roland Haefeli said.
The Actelion study showed patients who took the drug at its
highest dose showed an improvement of 23 meters in a six-minute
walk test. But the distance fell short of Bayer's
drug riociguat, which helped patients improve their walking
distance by 36 metres on average.
Deutsche Bank analysts, however, said comparison of walking
distance benefit was "invalid and irrelevant" and they saw
limited threat from riociguat.
"Confirmation that there is no "devil in the detail" should
help further convince (that) Actelion can negotiate its Tracleer
patent-cliff," they said.
The data did not show a significant risk of liver damage, a
major downside of Tracleer. Side effects included headache,
anaemia and nasopharyngitis, also known as the common cold.
Actelion said in April that the drug lowered the risk of
death and the disease worsening by 45 percent, sending the
shares up 18 percent.
In morning trade the shares were down 1.2 percent.
The stock has gained more than 40 percent so far this year
after the company survived a bid from activist investor Elliott
Advisors to seize control in 2011. This compares with a 11
percent rise in the European healthcare index.
(Editing by Edwina Gibbs and Louise Heavens)