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) (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  Rico.  * 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 Clinicaltrial.gov 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  2020.^3  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 http://www.dengue.info and  at  http://asia.dengue.info/  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  systems.  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:  www.sanofipasteur.com or www.sanofipasteur.us  References  1.World Health Organisation. Dengue haemorrhagic fever: diagnosis,     treatment, prevention and control. 2nd edition. 1997.     http://www.who.int/csr/resources/publications/dengue/Denguepublication/en/     (accessed 7 June 2014 2014) 2.WHO Dengue and severe dengue fact sheet # 117 Updated March 2014     Available at http://www.who.int/mediacentre/factsheets/fs117/en/ 3.World Health Organization (WHO). Global strategy for dengue prevention     control: 2012-2020. Available at:     http://reliefweb.int/sites/reliefweb.int/files/resources/9789241504034_eng.pdf.     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.  Contacts:  Global Media Relations         Sanofi Investor Relations  Alain Bernal                  Sébastien Martel T. +33-4-37-37-50-38          T. + 33 1 53 77 45 45 alain.bernal@sanofipasteur.com ir@sanofi.com www.sanofipasteur.com  Link to PDF Version http://hugin.info/152918/R/1821032/630465.pdf  HUG#1821032  
Press spacebar to pause and continue. Press esc to stop.