Sanofi begins trial to widen use of heart drug Multaq

* Trial with 10,800 patients seeks to extend Multaq use

* Multaq to be tested for permanent atrial fibrillation

* First patient to be enrolled in Q3

PARIS, May 12 (BestGrowthStock) – Sanofi-Aventis (SASY.PA: ) has begun
a clinical trial testing Multaq in patients with permanent
atrial fibrillation, or irregular heart beat, possibly extending
the heart drug’s use to a larger group of patients.

The final stage Phase IIIb trial aims to show that Multaq,
which has been touted as a blockbuster, reduces cardio vascular
diseases like stroke, systemic arterial embolism — when clots
block the blood flow — heart attack or death from heart
failure.

Another possible outcome Sanofi seeks is that Multaq could
reduce hospitalisation for heart problems or cut the number
deaths among patients with permanent atrial fibrillation.

“This is a trial of major significance since no
anti-arrhythmic drug has ever been shown to reduce major
morbidity and mortality in permanent AF patients in a
large-scale clinical trial,” said Stuart Connolly, MD, Division
of Cardiology, McMaster University, Hamilton, Canada, one of the
trial’s principal investigators.

Sanofi has been marketing Multaq, chemically known as
dronedarone, in the United States and in several European
countries since late July 2009 and until the end of the first
quarter sales reached nearly 50 million euros ($63.52 million).

Multaq was cleared to prevent recurrence of irregular heart
beat which is when the heart’s upper chambers beat in an
ucoordinated manner and lead to palpitations, shortness of
breath and fatigue, raising the risk of more serious heart
problems or stroke.

The new trial, dubbed Pallas, involves 10,800 patients
across 43 countries and will compare the efficacy of Multaq
400mg twice-daily with placebo. All patients will receive
standard treatment to control heart rate and prevent blood
clots.

Sanofi said that with an ageing population an increasing
number of people are suffering from atrial fibrillation which
increases the risk of stroke and doubles the risk of death.

Multaq is seen as one of the growth drivers for Sanofi as it
is facing a loss in sales of patent expiries.

Investing Tools
(Reporting by Caroline Jacobs)
($1=.7872 Euro)

Sanofi begins trial to widen use of heart drug Multaq