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Sanofi-aventis Initiates 10,000 Patient Study With Multaq(R) in Permanent Atrial Fibrillation

Paris, May 12, 2010 (ots/PRNewswire)

Sanofi-aventis  announced today
the initiation of a multinational, randomized, double-blind Phase
IIIb trial, PALLAS, to assess the potential clinical benefit of
Multaq(R) (dronedarone) in over 10,000 patients with permanent atrial
fibrillation (AF) to reduce major adverse cardiovascular events. The
announcement was made during Heart Rhythm 2010, the Heart Rhythm
Society's 31st Annual Scientific Sessions.
To view the Multimedia News Release, please click:
http://multivu.prnewswire.com/mnr/prne/sanofiaventis/42428/
Permanent AF afflicts 50% of patients suffering from AF and these
patients are at high risk of major adverse cardiovascular events. The
trial rationale was based on post-hoc findings from the landmark
ATHENA trial, in which a trend towards reduction of CV
hospitalization and death was seen in patients classified as
"permanent" (i.e. with AF/AFL at each ECG recording).
"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. "We designed the
PALLAS trial to further assess the role of Multaq(R) to reduce
cardiovascular outcomes in patients with AF."
The primary objective of the PALLAS trial is to demonstrate a
reduction in either or both of two composite outcomes which are 1.
major cardiovascular events (stroke, systemic arterial embolism,
myocardial infarction or cardiovascular death) or 2. cardiovascular
hospitalization or death from any cause among patients with permanent
atrial fibrillation and additional risk factors. The secondary
objectives are to evaluate the efficacy of Multaq(R) in preventing
cardiovascular death and whether the drug is well-tolerated in this
patient population.
"The initiation of the PALLAS trial confirms our strong belief in
Multaq(R) and our commitment to improve AF patient well-being and
overall cardiovascular health," said Marc Cluzel, MD, Executive Vice
President, Research and Development, sanofi-aventis. "We are looking
forward to first patient enrolment of PALLAS in the third-quarter
2010."
About PALLAS
PALLAS* is a multinational, randomized, double-blind,
parallel-group, placebo-controlled, multicenter Phase IIIb trial
comparing the efficacy of Multaq(R) 400mg twice-daily with placebo in
permanent AF patients. All patients will receive standard treatment
to control heart rate and prevent blood clots (antithrombotic
therapy); patients will be randomized to receive additional treatment
with either Multaq(R) 400mg BID or placebo.
Required risk factors include age above 65 years with at least
one of the following major risk factors: systemic arterial embolism,
myocardial infarction, documented coronary artery disease, prior
stroke, symptomatic heart failure, or the combination of age above 75
years, hypertension and diabetes mellitus. Exclusion criteria include
patients with New York Heart Association (NYHA) Class IV heart
failure or unstable NYHA Class III heart failure.
The trial has two composite co-primary endpoints: 1. Major
cardiovascular events (stroke, systemic arterial embolism, myocardial
infarction or cardiovascular death). 2. Cardiovascular
hospitalization or death from any cause.
There will be 10,800 patients enrolled in 43 countries at 700
sites. The trial is event-driven with a fixed Common Study End Date,
meaning that the study duration will depend upon the occurrence of a
statistically required number of outcome events.
*Permanent Atrial fibriLLAtion outcome Study using Dronedarone on
top of standard therapy (PALLAS)
About Permanent Atrial Fibrillation
The incidence of atrial fibrillation is growing worldwide in
relation to aging populations. It is emerging as a public health
concern, affects about 4.5 million people in Europe and represents
one-third of hospitalizations for arrhythmia in the European Union.
Atrial fibrillation leads to potential life-threatening
complications. AF increases the risk of stroke up to five-fold,
worsens the prognosis of patients with cardiovascular risk factors,
and doubles the risk of mortality with significant burden on
patients, health care providers and payers. Seventy percent of AF
management costs are driven by hospital care and interventional
procedures in the European Union.
According to ACC/AHA/ESC guidelines, permanent AF is the
designation given when sinus rhythm cannot be sustained after
cardioversion of AF (medical intervention designed to restore sinus
rhythm) or when the patient and physician have decided to allow AF to
continue without further efforts to restore sinus rhythm.[i] In the
Euro Heart Survey one year follow-up, one year mortality in patients
suffering from AF was high and the risk continuously present.
Mortality (5.3%) was comparable with results of previous studies,
which is also the case for the observed higher mortality in permanent
AF than in other AF types.[ii]
About Multaq(R)
Multaq(R), discovered and developed by sanofi-aventis, has been
studied in a clinical development program, including seven
international, multicenter, randomized clinical trials involving more
than 7000 patients with almost 4000 patients receiving Multaq(R). The
landmark ATHENA trial was the largest anti-arrhythmic drug trial
conducted in patients with AF/AFL, involving 4,628 patients with a
follow-up of 30 months. In this trial, Multaq(R), on top of standard
cardiovascular therapy, significantly reduced cardiovascular
hospitalization or death by 24 percent (p<0.001) when compared to
placebo, meeting the study's primary endpoint. This result was
entirely attributable to a reduction in cardiovascular
hospitalization.
Multaq(R) has a fixed dose regimen of twice daily 400 mg tablets
to be taken with morning and evening meals. Treatment with Multaq(R)
does not require a loading dose and can be initiated in an outpatient
setting. Most common adverse reactions are diarrhea, nausea,
vomiting, abdominal pain, asthenia (weakness) and skin rash.
The European Commission granted marketing authorization for
Multaq(R) in November 2009. Multaq(R) is indicated in the EU in adult
clinically stable patients with a history of, or current
non-permanent atrial fibrillation (AF) to prevent recurrence of AF or
to lower ventricular rate. The use of Multaq(R) in unstable patients
with NYHA class III and IV heart failure is contraindicated. Because
of limited experience in stable patients with recent (1 to 3 months)
NYHA class III heart failure or with Left Ventricular Ejection
Fraction (LVEF) <35%, the use of Multaq(R) is not recommended in
these patients[iii].
In the U.S., Multaq(R) is indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a
recent episode of AF/AFL and associated cardiovascular risk factors
(i.e., age >70, hypertension, diabetes, prior cerebrovascular
accident, left atrial diameter greater-than-or-equal-to 50 mm or left
ventricular ejection fraction [LVEF]  <40%), who are in sinus rhythm
or who will be cardioverted.[iv] Multaq(R) is  contraindicated in
patients with NYHA Class IV heart failure, or NYHA Class  II-III
heart failure with a recent decompensation requiring hospitalization
or referral to a specialized heart failure clinic.
Multaq(R) is currently available in the U.S., Canada,
Switzerland, Germany, Denmark, Ireland, Norway, Finland and the UK
and is being launched in most European countries in 2010.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris  and in New
York . For more information, please visit:
http://www.sanofi-aventis.com.
Forward-Looking Statement
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial results,
events, operations, services, product development and potential and
statements regarding future performance. Forward-looking statements
are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar expressions.
Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties inherent
in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such
as the FDA or the EMA, regarding whether and when to approve any
drug, device or biological application that may be filed for any such
product candidates as well as their decisions regarding labelling and
other matters that could affect the availability or commercial
potential of such products candidates, the absence of guarantee that
the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth
opportunities as well as those discussed or identified in the public
filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form
20-F for the year ended December 31, 2009. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
[i] Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006
Guidelines for the Management of Patients with Atrial Fibrillation: a
report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines and the European
Society of Cardiology Committee for Practice Guidelines (Writing
Committee to Revise the 2001 Guidelines for the Management of
Patients With Atrial Fibrillation): developed in collaboration with
the European Heart Rhythm Association and the Heart Rhythm Society.
Circulation 2006;114(7):e257-354.
[ii] Nieuwlaat R, Prins MH, Le Heuzey JY, et al. Prognosis,
disease progression, and treatment of atrial fibrillation patients
during 1 year: follow-up of the Euro Heart Survey on atrial
fibrillation. Eur Heart J 2008;29(9):1181-9.
[iii] European Medicines Agency. European Public Assessment
Report. Doc. Ref.: EMA/625172/2009; EMEA/H/C/1043
[iv] MULTAQ U.S. Prescribing information
http://products.sanofi-aventis.us/Multaq/Multaq.pdf

Contact:

CONTACT: Media Contact: Ingrid Gorg-Armbrecht, +33-1-53-77-46-25
or+33-6-38-10-50-87, ingrid.goerg-armbrecht@sanofi-aventis.com

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