Sanofi: First Ever Dengue Vaccine Candidate To Show Efficacy Against Dengue Fever and Dengue Haemorrhagic Fever in Asia

 Sanofi: First Ever Dengue Vaccine Candidate To Show Efficacy Against Dengue
                 Fever and Dengue Haemorrhagic Fever in Asia

First Ever Dengue Vaccine Candidate To Show Efficacy Against Dengue Fever and
                      Dengue Haemorrhagic Fever in Asia

 - 88.5% reduction of Dengue Haemorrhagic Fever shown in detailed analyses of
       world's first phase III efficacy study published in The Lancet -

             - Two thirds reduction in hospitalization observed -
 - Favorable safety profile is consistent with safety documented in previous
                                  studies -

Lyon, France - July 11, 2014 - Sanofi Pasteur, the vaccines division of Sanofi
(EURONEXT: SAN and NYSE: SNY), today  announced the publication in The  Lancet 
of the  detailed  results of  its  first  landmark phase  III  dengue  vaccine 
efficacy study  conducted in  five  countries in  Asia. Results  show  overall 
efficacy against symptomatic dengue of 56.5%*  in children aged 2 to 14  years 
old after a  three-dose vaccination  schedule. Importantly,  analyses show  an 
88·5%* reduction  of dengue  haemorrhagic fever,  the severe  form of  dengue, 
according to the WHO criteria^1. The study also showed a clinically  important 
reduction in the  risk of  hospitalization due to  dengue by  67%* during  the 
study. The  favorable vaccine  safety  profile observed  during the  25  month 
follow up of the phase III study in Asia is consistent with the safety profile
documented in other studies (phase I, II, IIb).

Dengue is a threat to  nearly half the world's  population, and is a  pressing 
public health  priority in  many countries  in Asia  and Latin  America  where 
epidemics occur.  The study  confirmed  the very  high  burden of  disease  by 
revealing that  one in  twenty children  in the  control group  suffered  from 
dengue each year, which  was three-fold higher  than initially expected.  Each 
year, an  estimated 500,000  people, including  children, have  severe  dengue 
requiring hospitalization.^2 This  puts huge  strain on  hospitals and  health 
care systems during outbreaks.^2

"The results of this first phase III  study show the potential of the  vaccine 
to have a significant  impact on public health,"  commented Dr. Maria  Rosario 
Capeding,  study  principal  investigator,  Research  Institute  for  Tropical 
Medicine, the Philippines. "The threat  of severe dengue disease creates  fear 
in the community. The vaccine's impact on preventing dengue haemorrhagic fever
is noteworthy. A  vaccine that  is able to  avoid the  personal suffering  and 
reduce this significant health burden would change the lives of millions."

Safety analyses (solicited reactions,  unsolicited events and Serious  Adverse 
Events SAEs)  during the  study  showed similar  reporting rates  between  the 
vaccine and control  groups. SAEs  were consistent with  medical disorders  in 
this age group and were mainly infections and injuries. Safety is continuously
reviewed  by  an  independent  data  monitoring  committee.  To  date,  27,000 
children, adolescents and adults have been vaccinated with three doses of  the 
candidate dengue vaccine throughout the clinical studies.

"The high  efficacy  observed  against  severe dengue  and  the  reduction  of 
hospitalization by two thirds is an extremely important public health outcome.
Furthermore  this  dengue  vaccine  continues  to  meet  the  highest   safety 
expectations, which  is very  reassuring," commented  Professor Duane  Gubler, 
Professor and Founding Director of the Signature Research Program on  Emerging 
Infectious Diseases, Duke-NUS Graduate Medical School, Singapore, and Chairman
of the Partnership for Dengue Control.

"These pivotal phase III vaccine efficacy study results take us closer to  our 
ambition to bring the  first vaccine against dengue  to the world," said  John 
Shiver, Senior Vice  President, R&D  at Sanofi  Pasteur. "After  more than  20 
years of commitment in collaboration with the scientific community, we are  on 
course to make dengue the next vaccine-preventable disease. The  public-health 
implications of a future dengue vaccine are significant and these findings are
an important  stride towards  meeting the  WHO's strategic  goals of  reducing 
dengue mortality by half and morbidity by at least 25% by 2020."

The four  dengue virus  serotypes  have circulated  during  the study  with  a 
distribution representative of the epidemiology in Asia. The measured efficacy
of the vaccine  during the 25  months observation of  the study is  consistent 
across countries and  appears to vary  by dengue serotype  (between 34.7%  and 
72.4%) and by age. The results of this first, large-scale efficacy study  will 
be supplemented by results from a second, large-scale phase III study in Latin
America and the Caribbean, including more than 20,000 children and adolescents
aged 9 to  16 years  old from Brazil,  Colombia, Honduras,  Mexico and  Puerto 

* 56.5% (95% CI: 43.8-66.4); 88·5% (95% CI 58·2 to 97·9); 67.2% (95% CI:  50.3 
to 78.6).

About the Phase III clinical study conducted in Asia
The  Phase   III  clinical   study  conducted   in  Asia   is  a   randomized, 
observer-blind,  placebo-controlled  multicenter  trial.  A  total  of  10,275 
children aged 2 to 14 years from dengue endemic areas of Indonesia,  Malaysia, 
the Philippines, Thailand and Vietnam participated in the study from 2011-2013
and were randomized to either receive  three injections of the dengue  vaccine 
or a placebo (2  to 1 ratio)  at 6-month intervals.  The primary endpoint  was 
measured by  the number  of symptomatic  virologically-confirmed dengue  cases 
caused by any serotype. The study will continue with a long term follow up  of 
the study population until 2017. More information about the clinical study  is 
posted on under study code NCT01373281.

About Sanofi Pasteur's dengue vaccine program
Sanofi Pasteur has been working  on a dengue vaccine  for more than 20  years. 
The company's goal is to make dengue the next vaccine-preventable disease with
a safe and  effective dengue vaccine  accessible in all  regions of the  world 
where dengue is a public health issue. The company is committed to support the
WHO's ambition  to reduce  dengue mortality  by 50%  and morbidity  by 25%  by 

Sanofi  Pasteur's  dengue  vaccine  candidate  is  the  most  clinically  and 
industrially advanced vaccine candidate in development. Over 40,000 volunteers
are participating in the Sanofi Pasteur dengue vaccine clinical study  program 
(Phase I, II and III).

Two pivotal Phase  III efficacy  studies involve more  than 31,000  volunteers 
from Asia (Indonesia,  Malaysia, the  Philippines, Thailand  and Vietnam)  and 
Latin America (Brazil, Colombia, Honduras, Mexico and Puerto Rico). The  Phase 
III evaluations provide pivotal data  on efficacy, safety, and  immunogenicity 
of the vaccine candidate in  a broad population and different  epidemiological 
environments and assess the potential public  health impact of the vaccine  on 
the disease burden.

Additional information,  photos  and  videos  about  Sanofi  Pasteur's  dengue 
vaccine candidate are available  on the web  at and  at

About dengue
Dengue is caused by four  distinct virus serotypes transmitted by  mosquitoes. 
It is a threat to nearly half  of the world's population. Currently, there  is 
no specific treatment available  for dengue. It is  a health priority in  many 
countries of Latin America and Asia  where epidemics occur regularly. The  WHO 
estimates up to 100 million infections per year^2; however, the overall number
of people infected with dengue  globally is not fully  known. The WHO has  set 
the goal of  estimating the  true public health  burden of  dengue by  2015.^3 
Dengue is underreported  because the disease  is often misdiagnosed  due to  a 
large spectrum of  clinical symptoms  from mild non-specific  illness to  life 
threatening complications and because of  the limitations of the  surveillance 

Each year, an estimated 500,000 people, including children, with severe dengue
require hospitalization. About 2.5% affected  would die.3 Severe dengue  (also 
known as dengue haemorrhagic fever)  is a potentially deadly complication  due 
to plasma leakage, fluid accumulation, respiratory distress, severe  bleeding, 
or organ impairment.^2 Dengue places tremendous pressure on health systems and
straining medical  resources  resulting  in significant  economic  and  social 
impact. Timely access  to appropriate health  care is critical  to reduce  the 
risk of mortality  in case of  severe dengue. The  WHO has set  the target  to 
reduce dengue mortality by 50% and reduce morbidity by 25% by 2020.^3

About Sanofi
Sanofi, a  global  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 the new Genzyme. Sanofi is  listed in Paris (EURONEXT: SAN) and  in 
New York (NYSE: SNY).

Sanofi Pasteur,  the  vaccines division  of  Sanofi, provides  more  than  one 
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 EUR 1
million in  research  and development.  For  more information,  please  visit: or


1.World Health Organisation. Dengue haemorrhagic fever: diagnosis,
    treatment, prevention and control. 2nd edition. 1997.
    (accessed 7 June 2014 2014)
2.WHO Dengue and severe dengue fact sheet # 117 Updated March 2014
    Available at
3.World Health Organization (WHO). Global strategy for dengue prevention
    control: 2012-2020. Available at:
    Published 2012. Accessed April 3, 2014

^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,  2013. 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         Sanofi Investor Relations

Alain Bernal                  Sébastien Martel
T. +33-4-37-37-50-38          T. + 33 1 53 77 45 45

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