* Edoxaban matches warfarin with less bleeding in study
* Works best in patients at highest risk
* Drug on sale in Japan, submission in West by Q1 2014
* Doctors eye pricing as rival products jockey for sales
By Ben Hirschler
AMSTERDAM, Sept 1 A new blood clot preventer
from Daiichi Sankyo proved as effective as widely used
warfarin in treating a dangerous condition known as venous
thromboembolism and caused less bleeding, a large clinical trial
The Japanese drugmaker hopes the finding will help it take
on rivals including Bayer, Johnson & Johnson,
Pfizer and Bristol-Myers Squibb in a growing
market for novel pills to prevent blood clots, especially as the
drug appears to work best in sicker patients.
Industry analysts believe modern blood thinners to replace
warfarin could generate sales of more than $10 billion a year.
Daiichi's once-a-day drug, however, is the fourth new oral
anticoagulant and doctors at the European Society of Cardiology
congress, where the data were unveiled on Sunday, said it
remained to be seen if it had an edge over competitors.
"I'm uncertain as to the degree to which it moves the needle
forward," said Dr. Patrick O'Gara of Boston's Brigham and
Women's Hospital, who is also president-elect of the American
College of Cardiology.
He wanted to see how the new medicine, known as edoxaban,
performed once it was used more widely by doctors, while other
cardiologists said price would be an important factor in
weighing up the competing therapies.
"The world is changing pretty fast on cost and I have hopes
that part of that will mean competition brings the price down,"
said American Heart Association President Dr. Mariell Jessup.
The 60-year-old anticoagulant warfarin - originally
developed as rat poison - is effective in preventing clots but
is notoriously difficult to use because it requires careful
monitoring of patients' blood levels and dose adjustments.
Daiichi's drug met the main goal of the 8,292-patient venous
thromboembolism (VTE) study by working just as well as warfarin
in treating and preventing recurrence of the condition.
It also led to a significant reduction in the risk of
clinically relevant bleeding, which occurred in 8.5 percent of
patients on edoxaban compared with 10.3 percent of those taking
warfarin, according to the data. Bleeding is typically the most
troubling side effect of extended use of blood thinning drugs.
"This agent gets the job done," said Dr. Sidney Smith of the
University of North Carolina School of Medicine at Chapel Hill
of the results, which were also published in the New England
Journal of Medicine.
The relative reduction in bleeding risk was less than seen
in a study in July with Eliquis, or apixaban, from Pfizer and
Bristol - but doctors said it was not possible to make direct
comparisons as the studies were very different.
The edoxaban trial, dubbed Hokusai-VTE, used sicker
patients, including those with severe pulmonary embolism, and
also involved the initial use of heparin injections.
Dr. Harry Buller of Amsterdam's Academic Medical Center, who
led the new study, said the drug was especially effective in a
sub-group of patients with severe pulmonary embolism and poor
heart function, where treatment with edoxaban reduced the risk
of recurrent clots by 48 percent.
"It was a nice and surprising finding," he said.
Edoxaban is already approved in Japan, where it has been on
sale under the brand name Lixiana since 2011, and Daiichi's
research head Glenn Gormley it would now be submitted for
approval in Western markets by the first quarter of 2014.
VTE, a potentially fatal condition, includes blood clots in
the leg, known as deep vein thrombosis, and clots in the lungs,
known as pulmonary embolism.
Daiichi is also developing edoxaban for preventing strokes
in people with atrial fibrillation (AF), a dangerously irregular
heart rhythm that is a bigger market. Data from another Phase
III trial using edoxaban in AF patients will be presented at the
American Heart Association annual meeting in November.
Gormley said the combination of the medicine's once-daily
dosing and its ability to help difficult-to-treat patients would
make it an attractive option for doctors.
Apart from Eliquis, other oral anticoagulants include
Xarelto from Bayer and Johnson & Johnson, and Boehringer
Some doctors have been wary of switching to the new
medicines in part because their blood-thinning effect is not
easily reversed in case emergency medical treatment, such as
surgery, is needed. Companies are testing agents that could be
used to reverse the blood thinning effect if necessary.