FRANKFURT Nov 13 German drugmaker Bayer
will start the largest drug trial so far involving
blood-thinner Xarelto in a bid to widen its use to become a
treatment for preventing repeat heart attacks.
As part of the trial with 20,000 participants, called
Compass, Bayer will try to show Xarelto can complement or
possibly replace Aspirin as the standard treatment for people
who have suffered a heart attack due to atherosclerosis, or
clogging of arteries.
The pill, jointly developed with Johnson & Johnson,
is already approved to prevent blood clots after major
orthopaedic surgery and to prevent strokes caused by a form of
irregular heartbeat common among the elderly.
Bayer expects to generate peak annual sales from Xarelto of
more than 2 billion euros ($2.5 billion), with stroke prevention
as the main contributor.
It stuck to that forecast on Tuesday, even when taking into
account the new targeted patient group, which is sizable.
About 100 million people in Western countries are currently
at a higher risk of suffering a heart attack because of
atherosclerosis, according to Bayer.
The Compass trial - in the third and last phase of testing
required for regulatory approval - will see participants in more
than 25 countries take Aspirin or Xarelto, or a combination of
"It's a three-arm study ... We hope that the combination in
particular will show a synergetic or complementary effect,"
Frank Misselwitz, Bayer's head of cardiovascular drug
development, told Reuters.
The trial will start in the first quarter of next year and
should last for about five years.
The yardstick will be which study arm has the fewest
incidents of heart attack, stroke or cardiovascular death. The
main side effect to be monitored will be major bleeding.
In a separate indication, Bayer and J&J have already been
trying to get approval for adding Xarelto to standard treatment
with Aspirin to prevent heart attacks and strokes in patients
with acute coronary syndrome (ACS).
In September it filed a response to U.S. regulators after
advisors expressed concern about bleeding risks.
($1 = 0.7868 euros)
(Reporting by Frank Siebelt and Ludwig Burger; Editing by Mark