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- First marketing authorization of Dengvaxia® is a historic milestone paving the way to significantly impact dengue burden in endemic countries - 

Lyon, France - December 9, 2015 - Sanofi Pasteur, the vaccines division of Sanofi, announced today that the Mexican authorities have granted marketing authorization to Dengvaxia®, making it the first vaccine to be licensed in the world for the prevention of dengue.

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved Dengvaxia®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults, 9 to 45 years of age living in endemic areas.

“When Sanofi set out to develop a dengue vaccine 20 years ago together with local and global public health and scientific communities, it was with the intention of developing an innovative vaccine to tackle this global public health need,” said Olivier Brandicourt, MD, Chief Executive Officer, Sanofi. “Today, with this first marketing authorization of Dengvaxia®, we have achieved our goal of making dengue the next vaccine-preventable disease. This is a historic milestone for our company, for the global public health community and, most importantly, for half the world’s population who lives at risk of dengue.”

The COFEPRIS approval of Dengvaxia® is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries. Dengue-endemic regions of Mexico participated in all three phases of the clinical development program for the vaccine.

“Dengue is a growing health threat in Mexico and many other tropical and subtropical countries in Latin America and Asia. The first vaccine approved to prevent dengue fever is a major innovation and a public health breakthrough. Dengvaxia® will be a critical addition to the integrated dengue prevention and control efforts. It will be an essential tool to boost on-going community efforts to relieve the long-standing suffering that this disease continues to bring to people in endemic countries like ours,” asserts José Luis Arredondo García, Associate Director of Clinical Research in the National Institute of Pediatrics*.

Regulatory review processes for Dengvaxia® are continuing in other endemic countries. Manufacturing of Dengvaxia® has already started at vaccine facilities in France and first doses are already produced. Sanofi Pasteur remains committed to introducing Dengvaxia® first in countries where dengue is a major public health priority.

The World Health Organization (WHO) has called for development of a dengue vaccine as an essential part of the integrated dengue prevention effort needed to significantly lower the dengue burden globally. The WHO has called on endemic countries to reduce dengue mortality by 50% and morbidity by 25% by 2020. Disease impact modelling results indicate if you vaccinate 20% of the population in the 10 endemic countries that participated in the Phase III efficacy studies for Dengvaxia, in the ages 9 and above indication, you could potentially reduce your dengue burden by 50% in five years.1 Such a significant disease reduction in this large at-risk population would result in a smaller pool of infected individuals in a given country and, therefore, fewer mosquitoes capable of transmitting the disease, potentially leading to an overall lowering of transmission risk for all.

*Pediatrician specialized in infectious diseases and coordinator of the Medical Science Master and PHD programs in the UNAM (National Autonomous University of Mexico), campus National Institute of Pediatrics.


Dengue disease burden

According to the WHO, dengue is the fastest growing mosquito-borne disease in the world today, causing nearly 400 million infections every year.2 Factors such as increased urbanization, mobility of populations and climate changes that increase the range of the dengue mosquito vector have created a perfect storm for dengue expansion. In the last 50 years dengue has spread from being present in a handful of countries to being endemic in 128 countries, where about 4 billion people live, and dengue incidence has likewise increased 30-fold in this time period.3,4

The mosquito that transmits dengue feeds mainly at dawn and dusk and can breed in very small amounts of standing water, making it a formidable foe for public-health workers and endemic community residents alike. Dengue is a painful disease that is also known as ‘break bone’ fever due to the terrible bone and joint pain it causes. In addition to this human suffering, dengue also has the ability to break the back of local healthcare systems during outbreaks. Globally, dengue is estimated to cost 9 billion USD annually in direct and indirect costs.5

Although dengue affects people from all ages and walks of life, the greatest number of dengue cases worldwide occurs in the highly mobile and social segment of the population that includes preadolescent to adult ages.6


About Sanofi Pasteur's dengue vaccine

Sanofi Pasteur’s vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine. Dengvaxia® successfully completed phase III clinical studies in 2014 to evaluate the primary objective of vaccine efficacy.7, 8

Long-term follow-up studies of the vaccine, recommended by WHO for all dengue vaccines in development, are currently ongoing. Additional pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were recently published in The New England Journal of Medicine reconfirming the vaccine’s consistent efficacy and longer-term safety profile in populations 9 years of age and older. In a pooled efficacy analysis in volunteers aged 9-16 who participated in the two Phase III 25-month efficacy studies, Dengvaxia® was shown to reduce dengue due to all four serotypes in two-thirds of the participants. Furthermore, this pooled efficacy analysis showed that Dengvaxia® prevented 9 out of 10 cases of severe dengue and 8 out 10 hospitalizations due to dengue in this age group.9

Dengvaxia® is the first vaccine licensed for the prevention of dengue in the world. First doses of the vaccine have been produced and full scale production capacity will be reaching 100 million vaccine doses annually.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at


About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in 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 a broad 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 EUR 1 million in research and development. For more information, please or


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 initiatives 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, 2014. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.



Global Media Relations 
Alain Bernal 
T. +33-4-37-37-50-38


Investor Relations 
Sébastien Martel 
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Latin American Media Relations 
Eleonora Leone 
T. +52 55 39 93 48 47



1 Coudeville L, Baurin N. Potential impact of dengue vaccination: insights from the first large-scale efficacy trials. Poster presented at 64th ASTMH Annual Meeting - October 25-29, 2015, Philadelphia, Pennsylvania, USA. Poster #3234. 
2 WHO Dengue and severe dengue fact sheet #117 visited 10 August 2015 
3 Ibid. 
5 Shepard DS, Halasa YA, Undurraga EA, Stanaway J. Global economic cost of dengue illness. Poster presented at: American Society of Tropical Medicine and Hygiene Annual Meeting; Oct. 25-29, 2015, Philadelphia, PA, Poster 781 
6 Egger JR, Paul G. Coleman. Age and Clinical Dengue Illness. Emerg Infect Dis. 2007 June; 13(6): 924–927. 
San Martin JL, Brathwaite O, Zambrano B, et al. The epidemiology of dengue in the americas over the last three decades:a worrisome reality. Am J Trop Med Hyg 2010;82:128-35
7 Capeding M.R., Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial ; Volume 384, Issue 9951, 11–17 October 2014, Pages 1358–1365. 
8 Villar L, Dayan GH, Arredondo-Garcia JL, Rivera DM, Cunha R, Deseda C et al. Efficacy of a tetravalent dengue vaccine in children in Latin America. N Engl J Med. 2015. 
9 Hadinegoro, Sri Rezeki S., et al. Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease Integrated Analysis of Efficacy and Interim Long-Term Safety Data for a Dengue Vaccine in Endemic Regions. July 27, 2015DOI: 10.1056/NEJMoa1506223. 


View related file


News Release

L-R: John Helou, President, Pfizer Canada Inc.; Mark Lievonen, President, Sanofi Pasteur Limited; Russell Williams, President, Rx&D



Montreal, November 17, 2015 – On behalf of the Board of Directors of Canada’s Research-Based Pharmaceutical Companies (Rx&D), President Russell Williams has conferred a Honourary Life Achievement designation to Mark Lievonen, President of Sanofi Pasteur Limited for his service and leadership in the innovative pharmaceutical industry in Canada.

This designation recognizes Mr. Lievonen’ leadership, outstanding achievements in the pharmaceutical industry and unwavering dedication to sustainable healthcare in Canada, as an outward reflection of Rx&D’s spirit of innovation. The award was given at a ceremony at the Making Canada Better 2015 Conference.


Quick Facts

  • Mark Lievonen has been President of Sanofi Pasteur Limited for 17 years and has been appointed to the Order of Canada.
  • He is the Past Chair of Rx&D’s Board of Directors, Vice-Chair of the Ontario Institute for Cancer Research and serves on the Boards of the Public Policy Forum and BIOTECanada.
  • He holds a BBA in accounting and an MBA in finance and marketing from York University and has received an honourary doctorate of laws degree from York University.
  • He is the recipient of the Queen’s Golden and Diamond Jubilee Medals and has been named a Chevalier de l’Ordre National de Mérite by the government of France.


“I’m grateful and tremendously proud, honored and humbled to receive this honour from Rx&D. It’s very gratifying to work in an industry that seeks to improve the quality of life for all Canadians. I’m fortunate to have worked with many inspiring individuals along the way – strong, passionate colleagues who share a like-minded approach to creating an innovative and sustainable healthcare system in Canada.” – Mark Lievonen, President, Sanofi Pasteur Limited

“Mark Lievonen has dedicated his entire career to advancing Canada’s life sciences ecosystem and working to demonstrate the incredible value of vaccines to Canadian health and healthcare sustainability. This recognition speaks directly to his dedication and it is well deserved.” – Russell Williams, President, Rx&D

“The entire Board of Rx&D is proud to celebrate Mark Lievonen’s many achievements and bestow this honour upon him. Mark is a strong advocate for the life sciences sector and the pharmaceutical industry in Canada and has forged strong relationships with many different stakeholders. He is a role model in his approach to pursuing solutions to address the complex challenges of our healthcare system.” – John Helou, Chair, Rx&D Board of Directors and President, Pfizer Canada Inc.

– 30 –

For further information:

Sarah Douglas
Media Relations, Rx&D
Telephone: 613-883-7250

About Canada’s Research-Based Pharmaceutical Companies

Canada’s Research-Based Pharmaceutical Companies is the national association representing the voice of Canada’s innovative pharmaceutical industry. We serve our membership by advocating for policies that enable the discovery, development and delivery of innovative medicines and vaccines to improve the lives of all Canadians. We support our memberships’ commitment to being a valued partner in the Canadian healthcare system. We represent more than 50 companies investing over $1-billion in R&D annually, fuelling Canada’s knowledge-based economy, while contributing over $3-billion overall to Canada’s economy. Guided by our Code of Ethical Practices, we work with governments, private payers, healthcare professionals and stakeholders in a highly ethical manner.

Image with caption: L-R: John Helou, President, Pfizer Canada Inc.; Mark Lievonen, President, Sanofi Pasteur Limited; Russell Williams, President, Rx&D.
Photographer: Denis Drever


- Sixty-one per cent of Canadians surveyed say the availability of an influenza vaccine covering four strains instead of three
would make them more likely to get vaccinated this flu season -

TORONTOSept. 30, 2015 - Public Health authorities in Canada are taking steps to enhance influenza vaccination programs this season by offering access to four-strain quadrivalent influenza vaccines (QIV), an important measure to help prevent B-strain mismatch and reduce the impact of influenza in the population.  

For almost four decades, influenza vaccines have covered three strains. These vaccines, known as trivalent influenza vaccines, or TIV, have offered protection against two influenza A strains and one B strain.1 However, in the 1980s, the B virus split into two distinct lineages (B/Victoria and B/Yamagata), which now co-circulate worldwide.2,3 As a result, between 2001 and 2013, there has been a mismatch between the influenza B strain in the vaccine and the circulating B strain more than 50 per cent of the time (seven out of 12 seasons).4 QIV can help protect against four different influenza virus strains, including the two influenza A strains and two influenza B strains.  

"A mismatch occurs when the predicted influenza strains in the vaccine are different from those circulating in the community; these mismatches can cause unexpected health implications," said Dr. Wayne Ghesquiere, Infectious Diseases and Internal Medicine Consultant, Vancouver Island Health Authority, and Clinical Assistant Professor of Medicine, University of British Columbia. "The potential for a mismatch between the B lineages is the reason behind the development of QIV. QIV helps reduce the possibility of B strain mismatches, which could result in better health outcomes, helps enhance public confidence and potentially boost annual vaccine uptake."  

Influenza B is unpredictable with some seasons seeing infection rates as low as 0.8 per cent to as high as 67 per cent of all circulating influenza viruses in Canada.5,6 Approximately 15 to 25 per cent of influenza-related hospital admissions and deaths are attributable to influenza B virus strains.7

Despite universal influenza vaccination programs offered by most provinces, only 25 to 30 per cent of adults between 18 to 64 years of age get the influenza shot each year.8 According to a recent survey that looked at opinions among Canadians about influenza vaccination, 57 per cent of those surveyed did not get vaccinated during the 2014/2015 season. Of these, almost half (48 per cent) said that their primary reason was due to their belief that the influenza vaccine would not be effective. Interestingly, 61 per cent of Canadians surveyed say the availability of an influenza vaccine containing four strains instead of three would make them more likely to get vaccinated this season; this suggests that the availability of a vaccine covering more strains could increase immunization rates.9

"Children and adults living with chronic conditions like asthma are at high risk of severe illness and complications from influenza, and the annual influenza vaccination is our best defense," said Noah Farber, Acting President and CEO, Asthma Society of Canada. "Having greater access to advanced vaccines is an important step in helping reduce the burden of influenza and helping protect those who are most vulnerable. We need to ensure all Canadians have access to these vaccines, so we can help increase overall health for everyone."

Currently, publicly funded access to QIV varies by province. A full QIV annual universal influenza immunization program is currently accessible to the general population six months of age and older in ManitobaYukon Territory, and several Atlantic provinces. Individuals in Canada who are interested in QIV should inquire with their local Public Health authorities regarding vaccine availability in their respective province.

The World Health Organization (WHO) recommends that QIV be used where available.10 It is quickly becoming the standard of care in the U.S. for individuals six months and older.

In Canada, there are three manufacturers offering quadrivalent vaccines this fall: Sanofi Pasteur, GlaxoSmithKline and AstraZeneca.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in 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 a broad 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 EUR 1 million in research and development. For more information, please visit: or


1Sanofi Pasteur Introduces 4-Strain Influenza Vaccine in Canada. Sanofi Pasteur. Accessed August 31, 2015. Available at  

2Belshe, RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine 2010.

3Sanofi Pasteur Introduces 4-Strain Influenza Vaccine in Canada. Sanofi Pasteur. Accessed August 31, 2015. Available at

4An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI) – Statement on Seasonal Influenza Vaccine for 2014-2015. National Advisory Committee on Immunization (NACI) July 2014.


62011-2012 FluWatch: August 12 to August 25, 2012 (Weeks 33 & 34). Public Health Agency of Canada. Accessed August 21, 2015. Available at

7Literature Review on Quadrivalent Influenza Vaccines. National Advisory Committee on Immunization (NACI) July 2014. AccessedAugust 31, 2015. Available at

8Influenza Immunization by Province. CANSIM. Statistics Canada. Accessed August 31, 2015. Available at  

9Flu Vaccines Survey, June 29-July 2, 2015. Leger, The Research Intelligence Group. Data on file.

10Influenza (Seasonal) Fact Sheet N°211 March 2014. World Health Organization. Accessed August 31, 2015. Available at

SOURCE Sanofi Pasteur

Image with caption: "Four-Strain Influenza Vaccine Available this Flu Season in Public Health Programs (CNW Group/Sanofi Pasteur)". Image available at:

For further information: or to arrange an interview, please contact: Sanofi Pasteur, Nancy Simpson, Director, Communications, T. 416.667.2955,


Every year, Sanofi Pasteur works in collaboration with the Canadian Nurses Foundation (CNF) to award a $5,000 scholarship to a nursing student who is studying in the area of public health. The winner of the 2015-2016 Sanofi Pasteur Limited Scholarship in Public and Community Health Award is Georgia Dewart of the University of Alberta.

Georgia is researching ways to improve access to health services and prenatal care. Thanks to the Sanofi Pasteur/CNF scholarship, Georgia hopes to expand her skills and knowledge in both research methodology and community-based harm reduction, ultimately to help foster equitable access to health care across Canada for women and vulnerable populations.

Sanofi Pasteur appreciates the critical role nurses play in public health – both in terms of patient care and delivery of health services. Support of nursing research and education is an important way to further their development and recognize the essential work they do.


In an appointment announced by Rideau Hall on July 1, J. Mark Lievonen was named a Member of the Order of Canada, in recognition of his outstanding achievements, leadership and unwavering commitment to the pursuit of sustainable healthcare.

Mark’s appointment is made possible through nominations by close friends and colleagues, Dr. Calvin Stiller and York Centre MPP Monte Kwinter. Both commended Mark for his dedication to making a difference for all Canadians, citing his work with Sanofi Pasteur, the Sanofi Biogenius Challenge, and a number of organizations including the Markham-Stouffville Hospital, the Ontario Cancer Institute, and York University.

MPP Kwinter spoke of Mark’s “visionary leadership” and his drive to stimulate innovation, Canadian competitiveness and productivity. “Mark has transformed Sanofi Pasteur Canada – a vital manufacturing and R&D hub – into a global, billion-dollar biotechnology enterprise which stands as a symbol of Canadian talent, innovation and R&D excellence,” he said.

The Order of Canada is the country’s highest honour for lifetime achievement. Mark joins a list of deserving Canadians including scientists, doctors, educators, artists, etc. who have made a significant impact in their fields. Click here to see a full list of 2015 appointments in the July 1, edition of The Globe and Mail.

Congratulations on this great honour, Mark!