Bayer drug’s safety comparable to standard care-study

* Safety record keeps Xarelto on track in new drug race

* Attention turns to stroke prevention study in Nov

STOCKHOLM, Aug 31 (BestGrowthStock) – Bayer’s (BAYGn.DE: )
anticoagulant Xarelto showed a similar safety profile compared
with standard therapy in clinical trial results released on
Tuesday, keeping it in the multibillion-dollar race to replace
the old and troublesome drug warfarin.

Experts had been waiting to see details of the study, after
the German drugmaker announced on Aug. 4 that Xarelto was as
good at dissolving potentially deadly clots in the legs and
preventing new ones as the standard treatment of injecting
Sanofi-Aventis’s (SASY.PA: ) Lovenox, followed by warfarin pills.

A key worry has been that Bayer’s potent new oral medicine
might cause excessive bleeding. In fact, the incidence of major
and non-major clinically relevant bleeds was identical in both
treatment groups, at 8.1 percent.

The number of major bleeds was, in fact, lower in the
Xarelto arm of the 3,400-patient trial at 14 compared with 20 in
the Lovenox plus warfarin arm, although the difference was not
significantly different.

Overall net clinical benefit — a measure of primary
efficacy outcome plus major bleeding — favoured Xarelto, with
2.9 percent of patients on Bayer’s medicine having a negative
outcome against 4.2 percent of those on standard care.

There was no signal of liver toxicity, an issue that has
concerned doctors with new types of anticoagulants.

Bayer and its partner Johnson & Johnson (JNJ.N: ) are training
their sights on an emerging warfarin-replacement market
estimated at more than $10 billion a year. Bayer has said
Xarelto, or rivaroxaban, could eventually generate more than 2
billion euros ($2.5 billion) in annual sales.

The big opportunity for new anticoagulants lies in
preventing strokes in patients with irregular heartbeats. In
that market, Bayer’s unlisted German rival Boehringer Ingelheim
is in the lead with a product called Pradaxa that will be
reviewed by a U.S. regulatory panel next month.

Bristol-Myers Squibb (BMY.N: ) and Pfizer (PFE.N: ) also
presented new data on their experimental apixaban in stroke
prevention at the Stockholm conference.

Results of a second Xarelto study looking at Bayer’s drug
when given to significantly older patients as a stroke preventer
will be presented at the American Heart Association annual
meeting in November.

(Reporting by Ben Hirschler; Editing by Erica Billingham)

Bayer drug’s safety comparable to standard care-study