Aplenzin(TM), the Only Single Tablet Once-Daily Treatment for Depression at All Doses,...

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Tue Apr 7, 2009 7:58am EDT

Aplenzin(TM), the Only Single Tablet Once-Daily Treatment for Depression at
All Doses, Now Available in the United States

BRIDGEWATER, N.J., April 7 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S.
announced today that Aplenzin(TM) (bupropion hydrobromide) extended-release
tablets, an effective bupropion therapy for the treatment of major depressive
disorder (MDD), is now available by prescription in the United States for
adults ages 18 and older. Aplenzin differs from other generic and branded
bupropion antidepressants because it provides a unique HBr salt
extended-release formulation, offering prescribers and their patients the
benefit of convenience with simple one tablet, once-daily dosing at all doses.


"For patients who show little clinical improvement on lower doses of
bupropion, there is a need to take higher doses to treat major depressive
disorder," said Prakash Masand, M.D., Consulting Professor of Psychiatry and
Behavioral Sciences, Duke University Medical Center, Durham, NC. "Aplenzin
offers patients and physicians an alternative option which only requires one
tablet, once a day at the highest bupropion dose.  This provides a simple,
convenient option for patients that currently need to take two to three
tablets daily."

For those patients in whom no clinical improvement is noted after several
weeks of treatment at the target dose of 348 mg per day, Aplenzin offers
physicians and their patients the ability to titrate up to the 522 mg
strength. The Aplenzin 522 mg dose is the only FDA-approved single-tablet,
once daily treatment equivalent to 450 mg of bupropion HCl therapy, requiring
two or three tablets daily.

"With major depressive disorder affecting about 14 million Americans, we are
excited to offer patients an effective treatment option that hopefully
addresses existing unmet needs," said Brent Ragans, Vice President and Head of
the General Therapeutics Business Unit, sanofi-aventis. 

Bupropion, the active ingredient in Aplenzin, offers comparable efficacy to
fluoxetine, an SSRI.  Bupropion also has low incidence of weight gain compared
to placebo. Research suggests that MDD may be caused by an imbalance of brain
chemicals called neurotransmitters.  The mechanism of action of Aplenzin is
unknown; however, it is believed that bupropion, the active ingredient of
Aplenzin, may help restore the balance of neurotransmitters, by inhibiting the
reuptake of norepinephrine and dopamine. 

Aplenzin was approved by the U.S. Food and Drug Administration (FDA) in April
2008. Sanofi-aventis U.S., which licensed Aplenzin from Biovail Corporation in
December 2008, markets the product in the United States and Puerto Rico. 

About Major Depressive Disorder
In the United States, it is estimated that between 10 percent and 25 percent
of women and five percent and 12 percent of men will experience a major
depressive episode at some point in their lives. Unlike normal emotional
experiences of sadness, loss or passing mood states, MDD is persistent (it may
last, on average, up to 16 weeks) and is usually associated with substantial
symptom severity and role impairment, contributing to reduced productivity.
According to one study, people with MDD reported an average of 35 days in the
past year when they were unable to work or carry out their normal activities.
MDD is associated with comorbid anxiety and substance abuse, and evidence
suggests it is a significant risk factor for stroke, hypertension, heart
disease, and death due to heart attack. The costs associated with MDD are
greater than those from hypertension and equivalent to those of heart disease,
diabetes and back problems combined. 

Research shows that only 57 percent of patients with MDD are treated for
depression in the primary care setting each year, with only one in five of
these patients receiving adequate treatment. The most common treatments for
MDD are antidepressants and psychotherapy. 

About Aplenzin

Indication:
APLENZIN is indicated for the treatment of major depressive disorder in adults
aged 18 years and older.

Important Safety Information:
Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in
short-term studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering the use of APLENZIN or any other antidepressant
in a child, adolescent, or young adult must balance this risk with the
clinical need. Short-term studies did not show an increase in the risk of
suicidality with antidepressants compared to placebo in adults beyond age 24;
there was a reduction in risk with antidepressants compared to placebo in
adults aged 65 and older. Depression and certain other psychiatric disorders
are themselves associated with increases in the risk of suicide. Patients of
all ages who are started on antidepressant therapy should be monitored
appropriately and observed closely for clinical worsening, suicidality, or
unusual changes in behavior. Families and caregivers should be advised of the
need for close observation and communication with the prescriber. APLENZIN is
not approved for use in pediatric patients.

APLENZIN is contraindicated in patients who have a seizure disorder, patients
being treated with Zyban(R) (bupropion HCl) Sustained-Release Tablets,
WELLBUTRIN(R) (bupropion HCl), WELLBUTRIN SR(R) (bupropion HCl)
Sustained-Release Tablets, or any other medications that contain bupropion,
patients who have or had bulimia or anorexia nervosa, patients undergoing
abrupt discontinuation of alcohol or sedatives (including benzodiazepines),
patients who have shown an allergic response to bupropion and patients taking
MAO inhibitors.  At least 14 days should elapse between discontinuation of an
MAO inhibitor and initiation of APLENZIN.

Physicians should be aware that bupropion is associated with a risk of
seizure, which is dose related. The incidence of seizure may be similar to
that of the sustained-release formulations of bupropion, since APLENZIN has
demonstrated bioequivalence. To reduce the risk of seizures, please see
WARNINGS and PRECAUTIONS in the Prescribing Information for patient selection
considerations, including concomitant medications and dosing recommendations.

Physicians, families, and caregivers should monitor patients for suicidality
as well as anxiety, agitation, panic attacks, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness),
hypomania, mania, and other unusual changes in behavior.  All patients should
be closely monitored for these symptoms, especially at the beginning of
therapy, or with changes in dose and reported immediately to the patient's
healthcare provider. Please consult prescribing information for APLENZIN for
additional monitoring recommendations. There is concern that such symptoms may
be precursors to suicidality, although a causal link has not been proven. If
such symptoms occur, prescribers should consider changing or discontinuing
treatment. Patients should be screened for bipolar disorder prior to
initiating treatment with an antidepressant.

When treating patients with severe hepatic cirrhosis, extreme caution should
be exercised, and a reduced dosage and/or frequency is required to avoid
accumulation. Increased restlessness, agitation, anxiety, and insomnia,
especially shortly after initiation of treatment, have been associated with
treatment with bupropion.  Neuropsychiatric signs and symptoms, including
delusions, hallucinations, psychosis, concentration disturbance, paranoia, and
confusion have been reported with bupropion.  Anaphylactoid reactions
characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnea
requiring medical treatment have been reported in clinical trials with
bupropion. There have been reports of hypertension, in some cases severe, in
patients receiving bupropion alone and in combination with nicotine
replacement therapy.

The most common adverse reactions reported are dry mouth, nausea, insomnia,
dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor,
palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency and
rash.  Please see the full prescribing information for additional safety
information.

The full prescribing information is available at www.aplenzin.com. 

About sanofi-aventis
Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global
pharmaceutical company that discovers, develops and distributes therapeutic
solutions to help improve the lives of patients.  Sanofi-aventis is listed in
Paris (EURONEXT: SAN) and in New York (NYSE: SNY). 

For more information, www.sanofi-aventis.us or www.sanofi-aventis.com

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 financial 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 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,
2008.  Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
or statements.

    Contact:
    Susan Brooks
    sanofi-aventis U.S.
    (908)-981-6566
    susan.brooks@sanofi-aventis.com


US.BUP.09.02.024


SOURCE  sanofi-aventis

Susan Brooks, sanofi-aventis U.S., +1-908-981-6566,
susan.brooks@sanofi-aventis.com
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