Sanofi Announces Auvi-Q, the First and Only Voice-Guided Epinephrine Auto-Injector, is Now Available in the U.S.

Mon Jan 28, 2013 8:04am EST

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-- Breakthrough device design talks patients and caregivers through the
injection process --
BRIDGEWATER, N.J.,  Jan. 28, 2013  /PRNewswire/ -- Sanofi (EURONEXT: SAN and
NYSE: SNY) announced today that Auvi-Q  (epinephrine injection, USP) is now
available in U.S. retail pharmacies nationwide with a prescription from a
healthcare provider.

(Photo:   http://photos.prnewswire.com/prnh/20130128/NY48939  )

Auvi-Q is the first-and-only epinephrine auto-injector with audio and visual
cues for the emergency treatment of life-threatening allergic reactions in
people who are at risk for or have a history of anaphylaxis. The size and shape
of a credit card and the thickness of a smart phone, Auvi-Q is a breakthrough in
epinephrine auto-injector device design that talks patients and caregivers
step-by-step through the injection process.   

"Patient feedback was a critical component to the development process for
Auvi-Q,"  said  Anne Whitaker, President, North America Pharmaceuticals, Sanofi.
 "The availability of Auvi-Q represents an important step forward in our
continued innovation to meet the needs of people at risk for anaphylaxis and
their caregivers."  

Up to six million Americans may be at risk for anaphylaxis, although the precise
incidence is unknown and likely underreported. While guidelines emphasize the
importance of the life-saving role of epinephrine, two large surveys (n=600 and
n=651) show that two-thirds of patients and caregivers do not carry their
epinephrine auto-injectors as recommended, and nearly half worry that others
will not know how to use their or their child's epinephrine auto-injector
correctly during an emergency. Multiple studies have found an association
between delay in epinephrine administration and death from anaphylaxis. 

Life-threatening allergic reactions may occur as a result of exposure to
allergens including foods such as peanuts, tree nuts, fish, shellfish, dairy,
eggs, soy and wheat; insect stings; latex and medication, among other allergens
and causes.  

About Auvi-Q  

Auvi-Q provides users with audible and visual cues, including a five-second
injection countdown and an alert light to signal when the injection is complete.
Auvi-Q also features an automatic retractable needle mechanism to help prevent
accidental needle sticks.  

Available in two different dosages, Auvi-Q 0.3mg delivers 0.3mg epinephrine
injection and is intended for patients who weigh 66 pounds or more. Auvi-Q
0.15mg delivers 0.15mg epinephrine injection and is intended for patients who
weigh 33 - 66 pounds. Auvi-Q has not been studied in patients weighing less than
33 pounds. Each Auvi-Q pack contains two devices - containing one dose of
epinephrine each - and a non-active training device. Auvi-Q received U.S. Food
and Drug Administration approval in  August 2012.

Sanofi US licensed the  North America  commercialization rights to Auvi-Q from
Intelliject, Inc., which has retained commercialization rights for the rest of
the world.  Eric and Evan Edwards, twin brothers who suffer from
life-threatening allergies, and co-founders of Intelliject, Inc., developed
Auvi-Q with a team of world class engineers and scientists. The development
process incorporated real-world experiences and feedback from patients and
caregivers.  

Auvi-Q has been named an International CES Innovations 2013 Design and
Engineering Awards Honoree.  The prestigious Innovations Design and Engineering
Awards are sponsored by the Consumer Electronics Association (CEA)®, the
producer of the International CES and the world's largest consumer technology
tradeshow.  http://www.cesweb.org/Awards/CES-Innovations-Awards.aspx.  

Indication

Auvi-Q (epinephrine injection, USP) is used to treat life-threatening allergic
reactions (anaphylaxis) in people who are at risk for or have a history of these
reactions.

Important Safety Information  

Auvi-Q is for immediate self (or caregiver) administration and does not take the
place of emergency medical care. Seek immediate medical treatment after use.
Each Auvi-Q contains a single dose of epinephrine.  Auvi-Q should only be
injected into your outer thigh.  DO NOT INJECT INTO BUTTOCK OR INTRAVENOUSLY. If
you accidentally inject Auvi-Q into any other part of your body, seek immediate
medical treatment. Epinephrine should be used with caution if you have heart
disease or are taking certain medicines that can cause heart-related (cardiac)
symptoms.  

If you take certain medicines, you may develop serious life-threatening side
effects from epinephrine.  Be sure to tell your doctor all the medicines you
take, especially medicines for asthma. Side effects may be increased in patients
with certain medical conditions, or who take certain medicines. These include
asthma, allergies, depression, thyroid disease, Parkinson's disease, diabetes,
high blood pressure, and heart disease.  

The most common side effects may include increase in heart rate, stronger or
irregular heartbeat, sweating, nausea and vomiting, difficulty breathing,
paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness,
or anxiety. These side effects go away quickly, especially if you rest.  

Talk to your healthcare professional to see if Auvi-Q is right for you.  

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit  http://www.fda.gov/medwatch  or call 1-800-FDA-1088.

Please click  here  for full prescribing information.  

About Anaphylaxis  

The signs and symptoms of anaphylaxis can vary from person to person and from
one episode to the next. Some people may have hives/itching, facial or tongue
swelling, which makes it difficult to breathe or swallow, while others may
experience nausea and vomiting. These symptoms may begin within seconds, minutes
or hours after exposure to the allergen. The best prevention method for
anaphylaxis is avoidance of the specific allergen(s).

When a severe, life-threatening allergic reaction occurs, epinephrine should be
administered immediately and patients and caregivers should seek immediate
medical attention. Patients and caregivers should always carry and know how to
use an epinephrine auto-injector to treat emergency allergic reactions. Without
treatment, anaphylaxis can result in death within a matter of minutes.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs. Sanofi has core
strengths in the field of healthcare with seven growth platforms: diabetes
solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare,
emerging markets and animal health. Sanofi is listed in  Paris  (EURONEXT: SAN)
and in  New York  (NYSE: SNY).  

Sanofi is the holding company of a consolidated group of subsidiaries and
operates in  the United States  as Sanofi US, also referred to as Sanofi-aventis
U.S. LLC. For more information on Sanofi US, please visit  http://www.sanofi.us
or call 1-800-981-2491.

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
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's
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,
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 product candidates, the absence of
guarantee that the product 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,
trends in exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements"
in Sanofi's annual report on Form 20-F for the year ended  December 31, 2011.
Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.

SOURCE  Sanofi


Media Relations - Marisol Peron, +(33) 1 53 77 45 02, marisol.peron@sanofi.com,
Jack Cox, +1-908-981-5280, Jack.cox@sanofi.com, Lori Lukus, +1-908-981-3876,
Lori.lukus@sanofi.com; Investor Relations - Sebastien Martel, +(33) 1 53 77 45
45, ir@sanofi.com, or George Grofik, +1-908-981-6031, George.grofik@sanofi.com,
all for Sanofi

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