* Macitentan company's big hope as Tracleer nears end of
* Drug improved walking distance by 23 metres
* Reduced the risk of all-cause mortality by 36 pct
* Halved risk of death and hospitalisation due to PAH
By Caroline Copley
ZURICH, Oct 24 Actelion's experimental
lung drug macitentan prolonged overall survival by more than a
third according to detailed study data, which the company hopes
will convince investors it has a viable follow-up product to
secure its commercial future.
Europe's largest standalone biotech company wants the drug,
which treats pulmonary arterial hypertension -- a disease that
causes high blood pressure in the arteries of the lungs -- to
replace blockbuster Tracleer.
Tracleer currently makes up 87 percent of sales but loses
patent protection in 2015 and has also seen its market share
eroded by 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 miligram dose of the drug reduced the risk of
all-cause mortality by 36 percent.
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.
Analysts at Jefferies said a trend towards overall survival
should be viewed as "sufficiently meaningful" for payers such as
"Overall the detailed data at the very least underscore our
confidence in macitentan's regulatory approvals and commercial
future, together we believe with providing ample ammo to
convince payers on favourable reimbursement/pricing," they said.
Jeffereies forecasts peak macitentan sales of $1.25 billion
assuming a 40 percent patient share.
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.
The FDA this week rejected a potential rival PAH drug,
telling United Therapeutics Corp that it was not sure
if another clinical study would alter its impressions but it
gave some guidance on what to do if the company decided to go
ahead with one.
In the Actelion study, doctors were also scrutinising data
which measures how far participants can walk in six minutes - a
commonly used benchmark in trials for drugs of PAH that enables
comparison with other therapies.
Patients on macitentan who took the 10 mg dose improved
their walking distance by 23 metres.
Taking the drug halved the risk of death or hospitalisation
due to PAH for those on a 10 mg dose and cut it by a third for
those on 3 mg - a significant reduction as hard-pressed
healthcare systems seek to cut costs by keeping patients out of
Actelion said in April that the drug decreased the risk of
morbidity and mortality in comparison to a placebo by 45 percent
in those patients given 10 milligrams of the drug and by 30
percent in those on 3 mg.
The company also plans to file macitentan for approval in
the European Union in the fourth quarter.
(Editing by Edwina Gibbs)