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Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

2008-08-08 07:00:00

Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation

    BRIDGEWATER, N.J., Aug. 8 /EMWNews/ -- Sanofi-aventis

(EURONEXT: SAN and NYSE: SNY) announced today that U.S. Food and Drug

Administration (FDA) has assigned priority review status for its New Drug

Application (NDA) for Multaq(R) (dronedarone). The priority review period

begins on July 31, 2008.



    The priority review is granted to applications in which a new

indication or new drug product, if approved, has the potential to present a

safe and effective therapy where no satisfactory alternative exists

compared to currently available therapies or marketed products.



    A registration dossier is also under regulatory review by the European

Medicines Agency (EMEA) for a Marketing Authorization Application.



    "We are pleased that the FDA has designated Multaq(R) for priority

review," said Marc Cluzel, sanofi-aventis Senior Vice President, R&D for

sanofi-aventis. "This follows the exciting results of the landmark ATHENA

study that showed Multaq(R) significantly decreased the risk of

cardiovascular hospitalizations or death from any cause in patients with

Atrial Fibrillation."



    Atrial fibrillation is a major cause of hospitalization and mortality

and affects about 2.5 million people in the United States, as well as 4.5

million people in the European Union and is emerging as a growing public

health concern due to an aging population. Patients suffering from atrial

fibrillation have twice the risk of death, an increased risk of stroke and

cardiovascular complications, including congestive heart failure.

Furthermore atrial fibrillation considerably impairs patients' lives,

mainly because of their inability to perform normal daily activities due to

complaints of palpitations, chest pain, dyspnoea, fatigue or

light-headedness.



    About Multaq(R) (dronedarone)



    Dronedarone (brand name Multaq(R)) is an investigational new treatment

for patients with atrial fibrillation, which has been discovered and

developed by sanofi-aventis for the prevention and treatment of patients

with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel

blocker that affects calcium, potassium and sodium channels and has

anti-adrenergic properties. Dronedarone does not contain the iodine radical

and did not show any evidence of thyroid or pulmonary toxicity in clinical

trials.



    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 (EURONEXT: SAN) and in New York

(NYSE: SNY).



    Forward Looking Statements



    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 product development, product potential projections

and estimates and their underlying assumptions, statements regarding plans,

objectives, intentions and expectations with respect to future events,

operations, products and services, 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 EMEA, 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 labeling 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 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,

2007. Other than as required by applicable law, sanofi-aventis does not

undertake any obligation to update or revise any forward-looking

information or statements.




U.S. Media Contact: Marisol Peron 908-981-6565 [email protected]

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Blake Masterson

Freelance Writer, Journalist and Father of 5

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