News Archives

08/13/2016
August 13th, 2016 



- First dengue immunization public program in the Americas starts today targeting broad age range of individuals at highest risk of disease consistent with recent WHO position - 

  

- Paraná state will lead Dengue prevention in Brazil launching benchmark public program to immunize 500,000 individuals with Dengvaxia® dengue vaccine over next three weeks - 


 

Paris, France - August 13th, 2016 - Sanofi and its vaccines global business unit Sanofi Pasteur announced that 500,000 doses of Dengvaxia® have been received in Paraná to support a large-scale public dengue immunization program initiated today in the State’s 30 most highly endemic municipalities. 

  

Paraná State, home to 10 million people, has seen a steep 3-fold increase in both dengue incidence and deaths in recent years. In the last year, there have been 55,000 cases reported, costing the State an estimated R$ 330 million (~91 M Euro) in related healthcare expenses. 



“For the public immunization program being launched today, we have used our extensive dengue surveillance data to ensure that we are targeting people at highest risk of disease. We will vaccinate all individuals 15-27 years of age in 28 municipalities and 9-44 years of age in the two municipalities with the top dengue burden in our State over the next three weeks,” said Michele Caputo Neto, Paraná Health Secretary.   



“Paraná has a good track record in vaccination coverage in general and successful implementation of this dengue immunization strategy could result in 74% reduction in disease burden in these highly impacted municipalities within 5 years, according to a dengue vaccine impact study published in the Brazilian Journal of Health Economics1,” Secretary Neto noted. 

  

Dr. Stephen J. Thomas, a physician-scientist at the Walter Reed Army Institute of Research in Silver Spring, Maryland who is an international dengue expert commented on the public immunization program initiated by Paraná State today. “Dengue remains one of the world’s most important mosquito transmitted diseases causing significant human suffering and financial cost. The strategic deployment of a safe and effective dengue vaccine offers the best hope of reducing dengue’s burden, especially in highly endemic countries like Brazil.”

  

Dengvaxia’s safety and efficacy have been documented in a large clinical study program involving more than 40,000 people in studies conducted in 15 countries around the world including Brazil which participated in both phases II and III of the clinical development of the vaccine. The safety, efficacy and public health value of the dengue vaccine has been independently endorsed by the World Health Organization (WHO) in position paper on Dengvaxia published on 29th July 2016 2, which is consistent with the earlier positive recommendation on the dengue vaccine issued by the WHO’s Strategic Advisory Group of Experts on Immunization last April. 

  

Guillaume Leroy, of Sanofi Pasteur, added “Introduction of the dengue vaccine first in endemic countries like Brazil has always been Sanofi Pasteur’s priority because this is where the vaccine can have the greatest impact on disease burden globally. Furthermore, successful implementation of Dengvaxia in a large-scale public program in Paraná will serve as a benchmark for dengue prevention efforts elsewhere in the country and in the world.”

  

Sanofi Pasteur will continue to address all supply demands coming from all clinics in Brazil, both public and private, as well as any additional requests from other countries supported by company’s ample dengue vaccine supply capacity from its production facility in France.




About Sanofi Pasteur commitment to public health in Brazil

Sanofi Pasteur is a leading vaccine provider in Brazil and a committed and longtime partner for public health in the country. Going back to 1974 the company produced and delivered 90 million doses of meningitis vaccine in record time to respond to an outbreak in Brazil. Sanofi Pasteur has partnered with the Butantan Institute in Brazil since 1999 to deliver seasonal influenza vaccines to the Brazilian population. In 2009 this partnership was instrumental in providing the pandemic A/H1N1 flu vaccine to the Brazilian government. In 2008, Sanofi Pasteur responded to a yellow fever outbreak in Brazil by delivering four million doses of yellow fever vaccine at the request of local health authorities and United Nation agencies. Since 2011, Brazilian infants have been receiving inactivated poliomyelitis vaccine provided via an agreement between Sanofi Pasteur and FIOCRUZ/ Biomanguinhos. 



About Sanofi Pasteur Dengue Vaccine

In addition to Brazil, Sanofi Pasteur Dengue Vaccine is also registered in Mexico, Philippines, El Salvador and Costa Rica to date. Regulatory review processes for Dengue Vaccine are continuing in other countries where dengue is a public health priority. 



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. 



A summary of the efficacy documentation on Dengvaxia for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two-thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.3



An integrated safety analysis was recently documenting Dengvaxia’s satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In addition, the results of this analysis documented that the vaccine provided beneficial protection against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination compared to placebo in the study population 9 years and older.4



Sanofi Pasteur Dengue Vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France. 



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



About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. 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 vaccines each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. 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: www.sanofipasteur.com or www.sanofipasteur.us



Sanofi 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, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.




Contacts:

Global Media Relations 

Jack Cox 

T. +33 (0)1 53 77 46 46

mr@sanofi.com


Global Sanofi Pasteur Communications 

Alain Bernal 

T. +33 (0)4 37 37 50 38 

alain.bernal@sanofipasteur.com

www.sanofipasteur.com


Investor Relations 

George Grofik  

Tel. +33 (0)1 53 77 45 45 

ir@sanofi.com


Brazil Media Relations 

Juliane Zaché 

T. +55 11 99 4035095

juliane.zache@sanofipasteur.com

www.sanofipasteur.com.br





1 Denizar V A, et al. Jornal Brasileiro de Economia da Saúde Brazilian Journal of Health Economics ABRIL 2016, VOLUME 8, NÚMERO 1 | APRIL 2016, VOLUME 8, NUMBER 1 

http://www.who.int/wer/2016/wer9130.pdf?ua=1

3 Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206 

4 Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials.Gailhardou et al PLoS Negl Trop Dis. 2016 Jul 14;10(7):e0004821. doi: 10.1371/journal.pntd.0004821 

 

07/07/2016
Paris, France – Le 6 juillet 2016 – Sanofi, et son entité mondiale vaccins Sanofi Pasteur,
annoncent aujourd’hui un accord de collaboration en matière de recherche et développement
(CRADA, pour Cooperative Research and Development Agreement) avec le Walter Reed Army
Institute of Resarch (WRAIR), concernant le codéveloppement d’un candidat vaccin contre le virus
Zika. D’après les termes de l’accord, le WRAIR cèdera à Sanofi Pasteur sa technologie relative au
vaccin purifié à base de virus Zika inactivé (ZPIV), ce qui ouvrira la voie à une collaboration plus
large avec le gouvernement américain.
 
L’accord inclut également la production de lots cliniques par Sanofi Pasteur, selon les bonnes
pratiques de fabrication (BPF), pour les essais de phase II, ainsi que l’optimisation du processus en
amont en vue d’améliorer la productivité, et la caractérisation du produit. Sanofi Pasteur établira
une stratégie en matière de développement clinique et de réglementation.

Le WRAIR partagera les données concernant le développement de tests immunologiques destinés
à mesurer les réponses en anticorps neutralisants suite à l’infection naturelle et à la vaccination
avec le vaccin Zika inactivé purifié, ainsi que les échantillons biologiques générés au cours des
études sur les primates non humains et les échantillons biologiques obtenus au cours des études
de tolérance et d’immunogénicité du vaccin Zika inactivé purifié chez les humains. Le WRAIR, le
National Institute of Allergy and Infectious Diseases (NIAID) [Institut national américain des
maladies allergiques et infectieuses - un des instituts nationaux de la santé des Etats-Unis] et la
Biomedical Advanced Research and Development Authority (BARDA) [Autorité responsable de la
recherche et du développement, rattachée au Bureau du secrétaire adjoint à la santé et aux
services sociaux pour la préparation et la riposte] ont coordonné le développement préclinique du
candidat vaccin, encouragés par les résultats des nouvelles études précliniques menées par le
WRAIR et le Beth Israel Deaconess Medical Center1. Le NIAID sera le promoteur d’une série
d’essais de phase 1 pendant que s’effectuera le processus de transfert de technologie.
« Nous avons recours à notre propre technologie, celle que nous utilisons pour le nouveau vaccin
contre la dengue, mais nous voulons étudier plusieurs pistes pour pouvoir tester cliniquement un
vaccin Zika dans les plus brefs délais. Cette collaboration passionnante avec le WRAIR devrait
ainsi nous permettre d’avancer rapidement, » a déclaré David Loew, Vice-Président Exécutif,
Sanofi Pasteur.

John Shiver, Docteur ès sciences, Senior Vice-Président R&D chez Sanofi Pasteur a expliqué que,
parallèlement aux travaux sur la technologie du WRAIR, Sanofi Pasteur effectue des études
précliniques fondées sur la technique déjà développée avec succès pour ses vaccins contre
l’encéphalite japonaise et contre la dengue. « Les virus de la maladie à Zika, de l’encéphalite
japonaise et de la dengue appartiennent tous à la même famille de virus (Flavivirus), sont transmis
par le même type de moustique et présentent des similitudes au niveau génétique, et nous avons
déjà homologué plusieurs vaccins contre ces flavivirus,» a-t-il souligné.

Mais comme l’a expliqué John Shiver, cette approche va demander plus de temps pour arriver au
stade des essais cliniques ; c’est pourquoi Sanofi Pasteur s’est tourné vers des partenariats avec
des experts extérieurs, de façon à disposer rapidement d’un candidat vaccin contre le virus Zika.
« Cette stratégie répond à la fois à des objectifs à court terme et à long terme : collaborer pour
arriver plus vite en phase d’essais cliniques et pouvoir proposer un vaccin dans la situation
d’urgence que nous connaissons actuellement, et adapter notre propre technologie pour pouvoir
assurer la production du vaccin pour les années à venir. »

A propos de Sanofi
Sanofi, un leader mondial de la santé, recherche, développe et commercialise des solutions
thérapeutiques centrées sur les besoins des patients. Sanofi possède des atouts fondamentaux
dans la prise en charge du diabète, les vaccins humains, les produits innovants, la santé grand
public, les marchés émergents, la santé animale et le nouveau Genzyme. Sanofi est coté à Paris
(SAN) et à New York (NYSE : SNY).
 
Sanofi Pasteur, la division vaccins de Sanofi, met à disposition plus de 1 milliard de doses de
vaccins chaque année, permettant de vacciner plus de 500 millions de personnes dans le monde.
Sanofi Pasteur est un leader mondial et produit des vaccins de haute qualité correspondant à ses
domaines d’expertise pour répondre à la demande de santé publique. L’expérience de Sanofi
Pasteur dans le domaine des vaccins remonte à plus d'un siècle. C’est aujourd'hui la plus
importante société entièrement dédiée au vaccin, qui investit plus d'un million d’euros par jour en
recherche et développement. Pour plus d'information, consulter le site: www.sanofipasteur.com/fr/default.aspx.

Déclarations prospectives

Ce communiqué contient des déclarations prospectives. Ces déclarations ne constituent pas des faits historiques. Ces
déclarations comprennent des projections et des estimations ainsi que les hypothèses sur lesquelles celles-ci reposent,
des déclarations portant sur des projets, des objectifs, des intentions et des attentes concernant des résultats financiers,
des événements, des opérations, des services futurs, le développement de produits et leur potentiel ou les performances
futures. Ces déclarations prospectives peuvent souvent être identifiées par les mots « s'attendre à », « anticiper », «
croire », « avoir l’intention de », « estimer » ou « planifier », ainsi que par d’autres termes similaires. Bien que la direction
de Sanofi estime que ces déclarations prospectives sont raisonnables, les investisseurs sont alertés sur le fait que ces
déclarations prospectives sont soumises à de nombreux risques et incertitudes, difficilement prévisibles et généralement
en dehors du contrôle de Sanofi, qui peuvent impliquer que les résultats et événements effectifs réalisés diffèrent
significativement de ceux qui sont exprimés, induits ou prévus dans les informations et déclarations prospectives. Ces
risques et incertitudes comprennent notamment les incertitudes inhérentes à la recherche et développement, les futures
données cliniques et analyses, y compris postérieures à la mise sur le marché, les décisions des autorités
réglementaires, telles que la FDA ou l’EMA, d’approbation ou non, et à quelle date, de la demande de dépôt d’un
médicament, d’un procédé ou d’un produit biologique pour l’un de ces produits candidats, ainsi que leurs décisions
relatives à l’étiquetage et d’autres facteurs qui peuvent affecter la disponibilité ou le potentiel commercial de ces produits candidats, l’absence de garantie que les produits candidats s’ils sont approuvés seront un succès commercial,
l’approbation future et le succès commercial d’alternatives thérapeutiques, la capacité du Groupe à saisir des
opportunités de croissance externe, l’évolution des cours de change et des taux d’intérêt, l’impact des initiatives de
maîtrise des coûts et leur évolution, le nombre moyens d’actions en circulation ainsi que ceux qui sont développés ou
identifiés dans les documents publics déposés par Sanofi auprès de l'AMF et de la SEC, y compris ceux énumérés dans
les rubriques « Facteurs de risque » et « Déclarations prospectives » du document de référence 2015 de Sanofi, qui a été
déposé auprès de l’AMF ainsi que dans les rubriques « Risk Factors » et « Cautionary Statement Concerning Forward-
Looking Statements » du rapport annuel 2015 sur Form 20-F de Sanofi, qui a été déposé auprès de la SEC. Sanofi ne
prend aucun engagement de mettre à jour les informations et déclarations prospectives sous réserve de la réglementation
applicable notamment les articles 223-1 et suivants du règlement général de l’Autorité des marchés financiers.

Contacts :
Relations Presse Monde                                          Relations Investisseurs
Alain Bernal                                                                George Grofik
Tél. +33 (0)4 37 37 50 38                                         Tél. +33 (0)1 53 77 45 45
alain.bernal@sanofipasteur.com                            ir@sanofi.com
07/06/2016

Paris, France, – July 6, 2016 – Sanofi and its vaccines global business unit Sanofi Pasteur

announced today a Cooperative Research and Development Agreement with the Walter Reed Army

Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. According to

the terms of the agreement, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine

technology to Sanofi Pasteur, opening the door for a broader collaboration with the U.S.

government.
 

The agreement also includes Sanofi Pasteur’s production of clinical material in compliance with

current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the

upstream process to improve production yields, and characterization of the vaccine product. Sanofi

Pasteur will also create a clinical development and regulatory strategy.
 

WRAIR will share data related to the development of immunologic assays designed to measure

neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic

samples generated during the performance of non-human primate studies, and biologic samples

generated during the performance of human safety and immunogenicity studies using ZPIV. WRAIR,

the National Institute of Allergy and Infectious Diseases (NIAID)--part of the U.S. National Institutes

of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA)--part

of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and

Response--have been coordinating pre-clinical development of the candidate encouraged by new,

pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center1. NIAID

will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring.

“In addition to exploring our own vaccine technology used in our new dengue fever vaccine, we are

looking at other pathways to get a Zika vaccine into the clinic as soon as possible. Therefore, this

exciting collaboration with the WRAIR creates the opportunity to rapidly move forward,” said David

Loew, Executive Vice President, Head of Sanofi Pasteur.

John Shiver, PhD, Sr. VP for R&D at Sanofi Pasteur, explained that while simultaneously working

on the WRAIR technology, Sanofi Pasteur is performing pre-clinical studies, utilizing a technology

previously and successfully developed for both its dengue fever and Japanese encephalitis

vaccines. “Zika, Japanese encephalitis, and dengue belong to the same family of viruses

(Flavivirus), are transmitted by the same type of mosquito, and share some similarities at the

genetic level, and we already licensed vaccines against those flaviviruses.”

 

However, he continued, since that pathway will take longer to get a Zika vaccine candidate into the

clinic, Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a

vaccine candidate. “We’re looking at this from both a short- and long-term perspective,

collaborating to get into the clinic quicker to provide a vaccine in response to the current emergency,

and adapting our own technology to ensure production capacity of a vaccine for years to come.”
 

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 produces a portfolio of high quality vaccines that matches its

areas of expertise and meets public-health demand. 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: www.sanofipasteur.com or www.sanofipasteur.us

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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Contacts:

Global Media Relations 
Alain Bernal 

Tel. +33 (0)4 37 37 50 38 

alain.bernal@sanofipasteur.com 

www.sanofipasteur.com 

U.S. Media Relations
Susan Watkins
Tel. + 570 957 2563
susan.watkins@sanofipasteur.com
www.sanofipasteur.com

 

Investor Relations

George Grofik

Tel. +33 (0)1 53 77 45 45

ir@sanofi.com

06/23/2016

New VaxigripTetra™ vaccine:

- A 4-strain influenza vaccine for people 36 months of age and older,

- Helps protect children, adults and seniors against both influenza B strains (B/Victoria and B/Yamagata),

- Newest addition to the Vaxigrip® family of influenza vaccines.

Lyon, France – June 23, 2016 – Sanofi Pasteur, the vaccines division of Sanofi, announced today that its quadrivalent influenza vaccine VaxigripTetra™ obtained a positive end of procedure from the German Reference Member State Paul Ehrlich Institute, as a conclusion of the European Decentralized Procedure. Marketing Authorizations can now be issued in the Reference Member State (Germany) and each of the Concerned Member States involved in this procedure. VaxigripTetra™ is a four-strain influenza vaccine, containing two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata), for use in individuals aged 36 months or older. VaxigripTetra™ is the newest addition to the Vaxigrip® family of influenza vaccines.

Currently, the majority of seasonal influenza vaccines are trivalent meaning that they protect against three strains: two A strains and a single B strain (B/Victoria or B/Yamagata). However, two distinct influenza B strains (B/Victoria and B/Yamagata) now co-circulate worldwide in varying and unpredictable proportions 1 . In recent years, influenza B viruses represented around 23% of the circulating strains around the world. These proportions can be as high as 90% during some seasons and are therefore an important cause of influenza disease2. Given this current virological situation with the co-circulation of the two B strains, influenza vaccines need to be adapted and to fit with the current virological situation to ensure broader level of protection. Because trivalent influenza vaccines only contain one B strain, this co-circulation makes the selection of the right strains to be included in the seasonal vaccine very difficult to predict. As an example in Europe in 2015 92%3 of the documented B influenza cases were caused by the B/Victoria strain not included in the vaccine. Adding the second B strain to VaxigripTetra™ will address the unpredictability issue.

“For over 60 years the expertise of Sanofi Pasteur has been committed to providing new immunization solutions for the prevention of influenza to better protect lives and help healthcare providers meet the specific immunization needs of all types of their patients. This new quadrivalent influenza vaccine, which includes both co-circulating B strains, completes our long line of Vaxigrip® family vaccines dedicated to fighting influenza infections and its complications. Once launched in Europe VaxigripTetra™ will offer broader protection for people from 36 months and older and support our public health ambition to constantly innovate to save lives worldwide” said David Loew, Executive Vice President Sanofi Pasteur.

The World Health Organization includes quadrivalent influenza vaccines in its recommendations, stating “Quadrivalent influenza vaccines that could potentially provide wider protection against influenza B viruses are becoming available and recommendations should not be limited to trivalent vaccine.” 4 From a public health perspective, using quadrivalent rather than trivalent influenza vaccines could have resulted in a further reduction of up to 1.6 million influenza cases, 37,300 influenza-related hospitalizations and 14,800 influenza-related deaths in the EU over a decade5.

Sanofi Pasteur supports influenza immunization policies and is committed to developing vaccine solutions that fit with the influenza epidemiology. VaxigripTetra™ is the newest formulation designed by Sanofi Pasteur, offering a quadrivalent influenza vaccine. VaxigripTetra™ includes two A strains and two B strains to help provide broader protection for all age groups as of 36 months. Sanofi Pasteur intends to progressively switch all its trivalent influenza vaccines to quadrivalent influenza vaccines worldwide.

 

About the evolution of influenza vaccines

Influenza viruses mutate often and the antigenic and ecological evolution results in the need to adapt the vaccine composition annually to ensure it remains effective 6.Each winter the strains for the seasonal influenza vaccines are selected from the influenza strains anticipated to circulate in the Northern Hemisphere during the approaching influenza season by WHO. Until 1978, seasonal influenza vaccines contained only two strains (one strain of type A influenza and one strain of type B influenza), when the decision was made to incorporate a second type A influenza strain to help provide protection against both A strains that were co-circulating7. Since then, influenza vaccines have been trivalent to help protect against three strains of influenza virus: a type A(H1N1), a type A(H3N2) and one type B.

However, since the 2001-2002 season, influenza B viruses have diverged into two antigenically distinct lineages (the Victoria and Yamagata lineages). Both B lineages have co-circulated with varying prevalence by season and region, supporting the need for extended protection with Quadrivalent influenza vaccines8.

 

About influenza and vaccination

Influenza is a serious respiratory illness9. Each year, 3 million to 5 million cases of severe illness are reported worldwide. Depending on virus virulence during the influenza season, influenza associated deaths can range from 250,000 to 500,000 people10 worldwide. In Europe, in the absence of vaccination, the annual burden related to influenza was estimated at 22 million cases, 3.5 million flu-associated hospitalizations and 171,000 flu-associated deaths11. Currently seasonal influenza vaccination prevents on average between 1.6 million and 2.1 million cases of influenza, 45,300 to 65,600 hospitalizations, and 25,200 to 37,200 deaths every year12.The World Health Organization recommends vaccination to help prevent influenza for everyone six months of age and older.

 

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 produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. 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: www.sanofipasteur.com or www.sanofipasteur.us

 

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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

Contacts:

Global Media Relations 

Alain Bernal

Tel. +33 (0)4 37 37 50 38

alain.bernal@sanofipasteur.com

www.sanofipasteur.com

 

Investor Relations

George Grofik

Tel. +33 (0)1 53 77 45 45

ir@sanofi.com

 

 

References

1 Hannoun, Expert rev. Vaccines 12(9), 1085‐1094 (2013)

2 Caini S et al, IORV 9 (supl 1), 3‐12 (2015)

3 http://ecdc.europa.eu/en/publications/Publications/ERLI‐Net%20report%20April%202016.pdf

4 http://www.who.int/wer/2012/wer8747.pdf?ua=1&ua=1

5 Public health and economic impact of seasonal influenza vaccination with quadrivalent influenza vaccines compared to

trivalent influenza vaccines in Europe, Human Vaccines & Immunotherapeutics, DOI: 10.1080/21645515.2016.1180490 ‐

http://www.tandfonline.com/doi/pdf/10.1080/21645515.2016.1180490

6 World Health Organization. Factsheet (Influenza). Available at:

http://www.who.int/mediacentre/factsheets/fs211/en/index.html. Accessed June 8, 2016

7 Hannoun, Expert rev. Vaccines 12(9), 1085‐1094 (2013)

8 Hannoun, Expert rev. Vaccines 12(9), 1085‐1094 (2013)

9 Centers for Disease Control and Prevention. Seasonal Influenza (Flu). Available at:

http://www.cdc.gov/flu/about/disease/index.html. Accessed October 11, 2013

10 World Health Organization. Factsheet (Influenza). Available at:

http://www.who.int/mediacentre/factsheets/fs211/en/index.html. Accessed June 8, 2016

11 Ryan et al. Vaccine 24 (2006) 6812–6822 :

12 Preaud et al. BMC Public Health 2014, 14:813:

06/21/2016

- Costa Rica is 5th country in the world to approve the dengue vaccine, which was recently endorsed by the WHO SAGE recommendations supporting the safety, efficacy and public health value of the dengue vaccine in endemic countries -

- Vaccine needed to address precipitous rise of dengue in Costa Rica, with greater than 500% increase in incidence in 2016 already compared to last year’s numbers -

 

Costa Rica – 21st June, 2016 - Today Sanofi Pasteur, Sanofi’s vaccine division, announced that the National Ministry of Health of Costa Rica has approved Sanofi Pasteur’s tetravalent dengue vaccine, Dengvaxia®to protect individuals 9 to 45 years of age living in endemic areas against all four serotypes of dengue.

This approval in Costa Rica is the fourth registration of the dengue vaccine in Latin America, and the fifth in the world. Sanofi Pasteur’s dengue vaccine has already been approved in Mexico, Brazil, El Salvador and the Philippines.

"Dengue is a disease that is beginning to hit us hard as a result of increased mobility and urbanization in the country. Already in 2016, we have recorded 7,711 cases of dengue at week 22 which is more than a 500% increase in incidence compared to last year,1” said Jorge Martinez, Pediatrician Member of the Pediatrician Society of Costa Rica. “Approval of the dengue vaccine gives us access to critical prevention tool against dengue to curb further spread of this debilitating disease in our country.”

In April 2016, the Strategic Advisory Group of Experts (SAGE) on immunization to the World Health Organization (WHO) recommended endemic countries to consider introduction of Dengvaxia® as part of integrated disease prevention including vector control and community mobilization.2 The WHO has set the objectives of reducing mortality by dengue by 50% and morbidity by 25% by 2020 in the endemic countries.3

“Dengue represents a growing and serious public health issue in many parts of the Americas with significant associated human and economic burden,” according to Cesar Mascareñas, Global Director of Medical Affairs for the Dengue Project, Sanofi Pasteur. “Approval of the dengue vaccine in Costa Rica will give the country’s healthcare providers access to the first clinical preventive tool against dengue, allowing them to better protect their patients against this threat.”

Public vaccinations against dengue began in the Philippines in April, with the goal of initiating the vaccination of 1 million fourth-grade students in highly-endemic regions of the country this year. Introduction of dengue vaccine in private and public immunization clinics in Brazil, Mexico and other countries in Central America are planned also to follow in coming months.

The global burden of dengue

According to the WHO, dengue is currently the fastest-growing mosquito-transmitted disease in the world, causing around 400 million infections every year. Over the last 50 years, dengue has spread; initially present in a handful of countries, it is now endemic in 128, inhabited by around 4 billion people. Also, the incidence of this disease has increased 30 times in this same period.4

Even though dengue affects people of all ages and lifestyles, the greatest number of dengue cases worldwide occurs in individuals 9 years of age and older, who represent a highly mobile and social segment of the community capable of contributing significantly to spread of the disease.5,6

About Sanofi Pasteur’s dengue vaccine

Besides Costa Rica, Sanofi Pasteur’s dengue vaccine has also been registered in Brazil, Mexico, El Salvador and the Philippines to date. Both private and public vaccinations against dengue have been successfully introduced in the Philippines and are being planned in other approval countries. The regulatory review process for the vaccine is continuing in other countries where dengue is a public health priority.

Sanofi Pasteur’s dengue vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in over 15 countries around the world. More than 40,000 volunteers participated in the dengue vaccine clinical study program (phase I, II and III), of whom 29,000 volunteers received the vaccine.7,8

Pooled efficacy and integrated safety analyses from the 25-month Phase III efficacy studies and the ongoing long-term studies, respectively, were published in The New England Journal of Medicine on July 27th, 2015, documenting the vaccine’s consistent efficacy and longer-term safety profile in a study population 9-16 years of age. In the pooled efficacy analysis in this age group, Sanofi Pasteur’s dengue vaccine was shown to reduce dengue caused by all four serotypes in two-thirds of the participants. Furthermore, this pooled analysis showed that Dengvaxia® prevented up to 93% of severe dengue cases and 8 out of 10 hospitalizations.9

Sanofi Pasteur’s dengue vaccine is the first and only vaccine licensed for the prevention of dengue in the world. The first vaccine doses have already been produced and shipped to countries in Asia and Latin America; the full-scale production capacity of the dedicated vaccine facility in France is 100 million vaccine doses annually.

Additional information about Sanofi Pasteur’s dengue vaccine is available on the web in Spanish at http://es.dengue.info/ or at www.dengue.info (in English).

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 provides a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. 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: www.sanofipasteur.com or www.sanofipasteur.us

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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts:

Global Media Relations

Alain Bernal

Tel. +33 (0)4 37 37 50 38

alain.bernal@sanofipasteur.com

www.sanofipasteur.com

 

Regional Media Relations

Marcela Jaramillo

Tel. +57 316466115

marcela.jaramillo@sanofipasteur.com

www.sanofipasteur.com

 

______________________________________________________________

1 Boletín epidemiológico No16-2016 Zika, Chikungunya y Dengue, 15 Jun. 2016

https://www.ministeriodesalud.go.cr/index.php/vigilancia-de-la-salud/analisis-de-situacion-de-salud/3055-boletinepidemiologico-no-16-2016-zika-chikungunya-y-dengue/file

http://www.who.int/immunization/sage/meetings/2016/april/en/. Last accessed 23 May 2016

3 World Health Organization. Global strategy for dengue prevention control 2012-2020. Geneva: WHO, 2012. Available at: http://apps.who.int/iris/bitstream/10665/75303/1/9789241504034_eng.pdf. Last accessed 23 May 2016

4 World Health Organization. Dengue and severe dengue. Factsheet No 117 http://www.who.int/mediacentre/factsheets/fs117/en/

5 Egger JR. Age and clinical dengue illness. Emerg Infect Dis. 2007;13:924-5

6 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 MR, et al. Lancet 2014;384:1358-65

8 Villar L, et al. N Engl J Med 2015;372:113-23

9 Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206

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