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Sanofi-aventis: Multaq(R) Receives Positive Recommendation by NICE in New Appraisal Consultation Document

March 29, 2010

PARIS, March 30, 2010 /PRNewswire-FirstCall/ — Sanofi-aventis (EURONEXT:
SAN, and NYSE: SNY) announced today that the National Institute for Health
and Clinical Excellence (NICE) in England and Wales, has just published a new
appraisal consultation document (ACD)[1] for Multaq(R) (dronedarone)
indicating its intention to recommend Multaq(R) use for the management of
patients with atrial fibrillation (AF).

The NICE appraisal committee’s preliminary recommendation is to endorse
Multaq(R) as a first choice therapeutic option after beta-blockers, which are
the initial therapeutic option in the NICE clinical guidelines. Based on this
recommendation, Multaq(R) should be prescribed in non-permanent AF patients
with at least one of the following cardiovascular risk factors: hypertension
requiring drugs of at least two different classes, diabetes mellitus,
previous transient ischemic attack, stroke or systemic embolism, left atrial
diameter of 50mm of greater, LVEF less than 40% or age 70 years or older and
who do not have unstable New York Heart Association (NYHA) class III or IV
heart failure.

This patient population corresponds to the patients included in the
landmark ATHENA study, the largest study ever performed with an
anti-arrhythmic drug in atrial fibrillation and the only study to have ever
demonstrated a positive impact on cardiovascular (CV) morbidity and mortality.

In ATHENA, Multaq(R) reduced the risk of cardiovascular hospitalization
or death by a significant 24% vs. placebo on top of standard of care
including beta-blockers (p<0.001) with no difference in the rate of serious
adverse events (19.9% vs 21.1% respectively; p = 0.31).

“Sanofi-aventis is pleased that NICE has acknowledged the benefits of
Multaq(R) for non-permanent AF patients who have been awaiting a new
therapeutic option that safely treats their symptoms and improves their
long-term cardiovascular outcomes,” declared Belen Garijo, Senior Vice
President, Pharmaceutical Operations Europe, sanofi-aventis. “We appreciate
the thorough and comprehensive evaluation of the Multaq(R) clinical and
economic dossier that NICE has performed and believe that this preliminary
recommendation by NICE provides a valuable benchmark to guide sanofi-aventis’
ongoing efforts to have the Multaq(R) value proposition in AF patients
recognized within Europe and beyond.”

Multaq(R) will be commercially available in the UK from today, Tuesday,
March 30, 2010
.

About Multaq(R)

Multaq(R), discovered and developed by sanofi-aventis, has been studied
in a clinical development program, including seven international,
multi-center, 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. [2] 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.

Multaq(R) is currently available in the U.S., Canada, Switzerland,
Germany, Denmark, Ireland, Norway and Finland 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 (EURONEXT: SAN) and in New York
(NYSE: SNY).

About NICE

The National Institute for Health and Clinical Excellence (NICE) is the
independent organization in the United Kingdom responsible for providing
national guidance on the promotion of good health and the prevention and
treatment of ill health. NICE produces guidance on the use of new and
existing medicines, treatments and procedures within the UK National Health
Service (NHS). NICE technology appraisal recommendations are prepared by
independent advisory committees called Technology Appraisal Committees, which
issue an Appraisal Consultation Document (ACD). The NHS is legally obliged to
fund (reimburse) and resource medicines and treatments recommended by NICE’s
technology appraisals.

    About the NICE process for Multaq(R)

    - The stakeholder consultation period for this ACD closes on
      22 April
    - Stakeholder comments submitted to NICE on this ACD will be
      considered at the Appraisal Committee Meeting on 26 May
    - If a Final Appraisal Determination (FAD) is produced
      following the Appraisal Committee Meeting it would be expected in early
      July
    - If the FAD is not appealed, publication of Final Guidance
      would be expected sometime between July and September.

1. This new appraisal document is not the final NICE guidance on
Multaq(R). A consultation period is ongoing until April 22nd, 2010. The
appraisal committee will meet again to consider the evidence on May 26, 2010.
After this meeting the Committee will prepare the final appraisal
determination (FAD) for Multaq(R).

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.

References:

[1] Hohnloser S.H, Crijns H.J.G.M., van Eickels M, et al. Effect of
Dronedarone on Cardiovascular Events in Atrial Fibrillation, N Engl J Med
2009; 360:668-78.

[2] European Medicines Agency. European Public Assessment Report. Doc.
Ref.: EMA/625172/2009; EMEA/H/C/1043

SOURCE Sanofi-aventis


Source: newswire