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 (SAN) and in New York (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)
6Public 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)
SOURCE: Sanofi Pasteur
Contact:
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
