* Bayer plans two new Phase III trials, one Phase II
* Trials could add to Xarelto's 5 approved indications
* Bayer won't say whether it may raise peak sales estimate
(Adds senior manager quotes, further details of trials)
FRANKFURT, Aug 29 Germany's Bayer
unveiled plans to launch three new studies to expand the uses of
its anti-clotting drug Xarelto, one of its top five new
Xarelto, which competes with the Eliquis pill developed by
Bristol-Myers Squibb and Pfizer in stroke prevention,
reached sales of $1.7 billion in the 12 months to June. Analysts
estimate annual sales could rise to more than $9.5 billion by
The drug, jointly developed with U.S. firm Johnson & Johnson
, is currently approved for uses including the prevention
of strokes caused by atrial fibrillation, a type of arrhythmia.
Bayer said on Friday that a Phase III trial involving about
7,000 patients would examine whether Xarelto can help prevent
the recurrence of strokes in patients who have suffered strokes
of undetermined cause.
"We really have just as many strokes due to undetermined
causes as to atrial fibrillation," Frank Misselwitz, head of the
Therapeutic Area Cardiovascular and Coagulation at Bayer
HealthCare, told Reuters.
A second Phase III trial announced on Friday will examine
the potential benefits of Xarelto in reducing thrombotic
vascular complications in more than 5,000 patients with
peripheral artery disease.
The third new study is a Phase II trial designed to evaluate
Xarelto for long-term prevention of acute coronary syndrome in
patients who have suffered from the illness. If the study
involving between 2,000 and 3,000 patients is successful, a
Phase III study will follow, Bayer said.
Misselwitz declined to say whether expanding the uses of
Xarelto would prompt Bayer to raise its estimate of the drug's
peak sales potential, which Chief Executive Marijn Dekkers has
so far put at about 3.5 billion euros a year.
"But these are major illnesses," Misselwitz said with
reference to the planned trials.
Bayer shares were flat at 1441 GMT, against a 0.8 percent
lower Dax index.
Xarelto is also currently used to treat and prevent deep
vein thrombosis and pulmonary embolisms and to reduce the risk
of strokes and blood clots in patients with an irregular heart
beat that is not caused by heart problems.
($1 = 0.7592 euro)
(Reporting by Frank Siebelt; Writing by Maria Sheahan; Editing
by Jonathan Gould and Pravin Char)