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Sanofi Pasteur Canada receives Health Canada Approval of Menactra® Meningococcal Conjugate Vaccine Indication for Infants

Sanofi Pasteur Canada receives Health Canada Approval of Menactra® 
Meningococcal Conjugate Vaccine Indication for Infants starting at 9 months 
Indication Provides Earlier Protection Against Meningococcal Disease 
TORONTO, Dec. 3, 2012 /CNW/ - Sanofi Pasteur, the vaccines division of the 
Sanofi Group (EURONEXT: SAN and NYSE: SNY), announced today that Health Canada 
has approved the expansion of the indication for Menactra(®) (Meningococcal 
[Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) 
down to infants nine months of age.(1) Menactra(®) is a vaccine for the 
prevention of meningococcal meningitis and meningococcal disease caused by 
strains A, C, Y and W-135 of the bacteria Neisseria meningitidis, in persons 
nine months through 55 years old.(2) 
Invasive meningococcal disease is an acute and serious illness caused by the 
bacterium Neisseria meningitidis.(3) In fatal cases, death can occur within 24 
to 48 hours after symptoms appear.(4) Of those who survive, some (11-19%) may 
suffer from permanent disabilities, including hearing loss, neurological 
damage, limb loss and paralysis.(5) Meningococcal disease most often occurs in 
children less than five years of age and peaks again in adolescence.(6) 
"Diagnosis of meningitis can be very difficult, as it mimics the symptoms of 
flu. Meningitis can lead not only to death, but lifelong health problems 
including brain damage, loss of limbs and developmental disorders," said Dr. 
Ron Gold, medical advisor for the Meningitis Research Foundation of Canada. 
"Approval for use of Menactra(®) vaccine as early as nine months of age 
expands our ability to prevent this potentially deadly disease in infants." 
Maureen Dennis, parenting expert and founder of WeeWelcome.ca, said, "After 
speaking with mothers who lost their children to meningitis, I became rather 
concerned and realized that there was much more to know about this preventable 
disease. It's unthinkable that an infant can quickly go from their crib to the 
ICU at Sick Kids, a fate no parent should experience. Parents need to know 
more about immunization and about meningitis in particular." 
Meningitis spreads through close, direct contact.(7) Coughing or sneezing, 
sharing eating utensils, kissing and close physical contact can spread the 
germs from person to person.(8) In Canada meningitis is most prevalent during 
winter and spring.(9) According to the Public Health Agency of Canada, between 
2005 and 2010, an average of 197 cases of invasive meningococcal disease was 
reported annually in Canada, with an average incidence of 0.60 cases per 
100,000 population.(10) 
About Menactra(®) Vaccine 
Menactra(®) (Meningococcal [Groups A, C, Y and W-135] Polysaccharide 
Diphtheria Toxoid Conjugate Vaccine) is a vaccine indicated for active 
immunization for the prevention of invasive meningococcal disease caused by N. 
meningitis strains A, C, Y and W-135 in persons age nine months through 55 
years of age.(11) 
Menactra(®) does not protect against disease caused by strain B, and is not a 
treatment for meningococcal infections or their complications.(12) The length 
of protection is currently not known.(13) As with any vaccine, Menactra(®) 
may not protect 100% of vaccinated individuals.(14) The amount of time it 
takes for your body to develop enough antibodies to protect you from 
meningococcal diseases can vary. It can take several days to a few weeks after 
your vaccination. Menactra(®) should not be used in persons with known severe 
allergy to any of its components or its container. Some persons may experience 
side effects, which are usually mild and go away within a few days, such as 
pain, redness or swelling at the injection site, headache, fatigue or 
drowsiness, lack of appetite.(15) Common side effects in infants also include 
fussiness, and increased crying.(16) Allergic reactions may occur.(17) A 
complete copy of the Product Monograph is available at www.sanofipasteur.ca. 
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, consumer healthcare, emerging 
markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) 
and in New York (NYSE: SNY). 
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion 
doses of vaccine each year, making it possible to immunize more than 500 
million people across the globe. A world leader in the vaccine industry, 
Sanofi Pasteur offers the broadest range of vaccines protecting against 20 
infectious diseases. The company's heritage, to create vaccines that protect 
life, dates back more than a century. Sanofi Pasteur is the largest company 
entirely dedicated to vaccines. Every day, the company invests more than $1.2 
million in research and development. For more information, please visit: 
www.sanofipasteur.ca 
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. 
____________________________
(1) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 5) 
(2) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 5) 
(3) Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(4) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 34) 
(5) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 34) 
(6)Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(7) Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(8) Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(9) Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(10) Public Health Agency of Canada. "Invasive Meningococcal Disease (IMD)" 
Available at: http://www.phac-aspc.gc.ca/im/vpd-mev/meningococcal-eng.php. 
Last accessed 14 November, 2012 
(11) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 5) 
(12) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 5) 
(13) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 29) 
(14) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 5) 
(15) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 39) 
(16) Sanofi Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 39) 
(17) Pasteur Canada MENACTRA® Product Monograph, June 2012 (page 39)   
Nancy Simpson, Sanofi Pasteur, Tel: 
416-667-2955,Nancy.simpson@sanofipasteur.com 
Jason Chennette, CASACOM, Tel: 416-894-0190,jchennette@casacom.ca 
Martine Venne, CASACOM, Tel: 514-286-2145,mvenne@casacom.ca 
SOURCE: Sanofi Pasteur 
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CO: Sanofi Pasteur
ST: Ontario 
-0- Dec/03/2012 10:59 GMT
 
 
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