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Sanofi Pasteur dengue vaccine research program

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					           LEADING DENGUE VACCINE CANDIDATE

                CHANGING THE LIVES OF MILLIONS


A GLOBAL PUBLIC HEALTH CHALLENGE


         Dengue fever, a mosquito-borne disease caused by
         four types of dengue viruses, is a threat for almost
         half of the world’s population(1).
         Dengue fever occurs mostly in tropical and
         subtropical countries (2) and is spreading to new
         parts of the globe each year. Many factors
         contribute to the spreading of dengue fever,
         including urbanization and increased travel which
         facilitate the dissemination and the circulation of           An Aedes Aegypti mosquito which
         this disease.                                                                 spreads dengue
         There is no specific treatment and vaccination is the only efficient means of fighting
         against dengue fever.
         Sanofi Pasteur, a world leader in vaccines, has taken on the challenge of providing
         the first dengue vaccine for individuals living in endemic areas and developing
         countries as well as for those who plan to travel to those areas.




   Key figures(1,3)…

   • 2.5 billion people at risk in
     over 100 countries
   • Estimated 220 million people
     infected annually
   • 2 million, mostly children,
     develop dengue hemorrhagic
     fever, a severe form of the
     disease




                                                    Source: WHO, Global Health Observatory Map Gallery, available on:
                                                    http://gamapserver.who.int/mapLibrary/Files/Maps/Global_DengueTransmission_I
                                                    THRiskMap.png




Vice President, Communications Sanofi Pasteur: Alain Bernal
Vice President, Media and Scientific Communications: Pascal Barollier +33 4 3737 5038
Vice President, U.S. Communications: Len Lavenda +1 570 957 0717
Sanofi Pasteur S.A. Headquarters - 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 - France
Sanofi Pasteur Inc. – Discovery Drive – Swiftwater, PA 18370-0187 – USA – www.sanofipasteur.com
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60 YEARS OF SCIENTIFIC ENDEAVOR

From early scientific discoveries ….

         1944: isolation and identification of the 1st serotype (in Hawaii, DEN1) and 2nd
         serotype (in N.Guinea, DEN2) by Sabin and Schelsinger(4).
         1944-45: first monovalent dengue vaccine, a live attenuated vaccine (LAV) DEN1,
         developed by Sabin and Schelsinger(4).
         1956: isolation and identification of the 3rd serotype (DEN3) and 4th serotype
         (DEN4) by W. Hammon(5).
         1970-1980: development of a tetravalent LAV DEN1, DEN2, DEN3, DEN4, by Pr
         Natth Bhamarapravati at the Mahidol University (Bangkok - Thailand). At this point,
         data from clinical investigations conducted in Thailand showed promise for a
         tetravalent dengue vaccine(6).

…. to the leading candidate dengue vaccine from Sanofi Pasteur

   « Sanofi Pasteur was the first vaccine company to invest in the research and
   development of a dengue vaccine, in the ‘90s. The scientific challenge for this vaccine
   was to choose the right approach to have a well tolerated vaccine that offers protection
   against the four serotypes of the dengue virus.” Jean Lang, MD, PhD, Head of the
   Dengue Vaccine program at Sanofi Pasteur.




Dengue virus under electronic microscope


Vice President, Communications Sanofi Pasteur: Alain Bernal
Vice President, Media and Scientific Communications: Pascal Barollier +33 4 3737 5038
Vice President, U.S. Communications: Len Lavenda +1 570 957 0717
Sanofi Pasteur S.A. Headquarters - 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 - France
Sanofi Pasteur Inc. – Discovery Drive – Swiftwater, PA 18370-0187 – USA – www.sanofipasteur.com
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   A long term commitment
       1994           Partnership between Sanofi Pasteur and the Vaccine Development Centre,
                      University of Mahidol (Bangkok - Thailand).

       2001           Proof of concept of a tetravalent live attenuated dengue vaccine in two doses
                      and a booster.
                      Start of the development of a second generation vaccine obtained by
                      recombinant technology.

       2004           Classical live vaccine approach abandoned due to reactogenicity and under-
                      attenuation of serotype 3. Sanofi Pasteur decides to adopt a new approach, with
                      a second generation live attenuated vaccine.

       2006           Partnership with PDVI (Pediatric Dengue Vaccine Initiative), a consortium
                      working to accelerate the introduction of a dengue vaccine for children in
                      endemic countries (supported by the Bill & Melinda Gates Foundation).

       2007           Positive results in phase II clinical studies; proof of concept.

       2009           Sanofi Pasteur dengue vaccine enters pediatric clinical efficacy study in
                      Thailand.

       June 2010 The U.S. FDA grants fast track status to Sanofi Pasteur candidate dengue
                 vaccine.

       Oct. 2010 Sanofi Pasteur dengue vaccine enters phase III clinical study.

       Feb. 2011 Partnership with the International Vaccine Institute to support the DVI (Dengue
                 Vaccine Initiative), a non-profit advocacy group focused on raising awareness of
                 dengue fever and supporting the introduction of dengue vaccination, funded by
                 the Bill & Melinda Gates Foundation.




Sanofi Pasteur dengue vaccine clinical study in Ratchaburi, Thailand



Vice President, Communications Sanofi Pasteur: Alain Bernal
Vice President, Media and Scientific Communications: Pascal Barollier +33 4 3737 5038
Vice President, U.S. Communications: Len Lavenda +1 570 957 0717
Sanofi Pasteur S.A. Headquarters - 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 - France
Sanofi Pasteur Inc. – Discovery Drive – Swiftwater, PA 18370-0187 – USA – www.sanofipasteur.com
                                                                                                        3
CLINICAL STUDIES: A PROGRAM TO COVER THE WORLD

         First vaccine to reach phase III
         clinical study, the ultimate steps in the
         clinical development of a vaccine before
         its introduction.
         15      endemic      and     non-endemic
         countries included in the Sanofi
         Pasteur global clinical study program
         (completed, ongoing and planned
         studies):
            • Studies     on-going     in  Mexico,      Dengue vaccine clinical study in Ratchaburi, Thailand
              Colombia, Honduras, Puerto Rico,
              Peru, the Philippines, Vietnam, Singapore, Australia, Thailand, Brazil and
              Indonesia.
         Globally, nearly 45,000 participants will be included in the Sanofi Pasteur clinical
         study program.
         Sanofi Pasteur dengue vaccine has been evaluated in clinical studies (Phase I, II) in
         adults and children in the United States, Asia and Latin America. A balanced immune
         response against all four serotypes was observed after three doses of the vaccine.
         The vaccine is well tolerated with a similar safety profile after each dose(7).
         Initial efficacy results from a Thai study are expected end of 2012.

   “Today, we are very excited to be in the last stage of clinical development. We are confident that
   we will be the first with a dengue vaccine within a few years. A dengue vaccine will fulfill an
   unmet medical need and change the lives of millions of people across the world.” Olivier
   Charmeil, President and CEO, Sanofi Pasteur.




           Countries hosting Sanofi Pasteur dengue vaccine clinical studies (completed and ongoing studies)
           Areas at risk of dengue: 2.5 billion people in over 100 countries
Vice President, Communications Sanofi Pasteur: Alain Bernal
Vice President, Media and Scientific Communications: Pascal Barollier +33 4 3737 5038
Vice President, U.S. Communications: Len Lavenda +1 570 957 0717
Sanofi Pasteur S.A. Headquarters - 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 - France
Sanofi Pasteur Inc. – Discovery Drive – Swiftwater, PA 18370-0187 – USA – www.sanofipasteur.com
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AN INDUSTRIAL PIONEER FOR GLOBAL HEALTH

In response to the global need for a dengue vaccine, Sanofi Pasteur is building a new
vaccine production center, located in France. The objective is to reduce the time necessary
to provide access to the vaccine once it is licensed.


      • 2009: start of construction
      • 2014: production site
        operational




                                                          Design of new dengue vaccine production site under construction




THE NEXT BATTLE:
ACCESS TO DENGUE VACCINATION FOR EVERYONE AT RISK

      Implementation of dengue vaccination
      programs face important challenges
      such as creating vaccination policies for
      the first dengue vaccine , as well as
      access and financing mechanisms for
      people most in need.
      It is urgent that the public health
      community work together to start
      preparing for vaccination programs.
      Sanofi Pasteur is joining efforts with
      international groups such as the DVI
      (Dengue Vaccine Initiative) to raise                Dengue vaccine clinical study in Ratchaburi, Thailand
      awareness and move dengue vaccination higher on the global health agenda.
      Collaboration efforts focus on accelerating the adoption and introduction of dengue
      vaccination and on making it accessible to those at highest risk of dengue.



(1)
    PDVI Newsletter N° 7, April 2010 available on: http://www.pdvi.org/PDVI_newsletter/newsletter.asp
(2)
    CDC - Outbreak Notice - Update: Dengue in Tropical and Subtropical Regions available on:
http://wwwnc.cdc.gov/travel/notices/outbreak-notice/dengue-tropical-sub-tropical.htm
(3)
    WHO - Dengue and dengue haemorrhagic fever, Fact sheet n°117, March 2009, available on:
http://www.who.int/mediacentre/factsheets/fs117/en
(4)
    Science 1945;101(2634):640-642
(5)
    Science 1960;131:1102-3
(6)
    AJTMH 2003;69(Suppl 6):5-11
(7)
    Saville et al, Clinical development of a tetravalent dengue vaccine for endemic areas, ICID Miami, March 2010;
Lang et al, Toward a tetravalent dengue vaccine in Brazil, Tropical Medicine meeting, Iguacu Falls, March 2010


Vice President, Communications Sanofi Pasteur: Alain Bernal
Vice President, Media and Scientific Communications: Pascal Barollier +33 4 3737 5038
Vice President, U.S. Communications: Len Lavenda +1 570 957 0717
Sanofi Pasteur S.A. Headquarters - 2, avenue Pont Pasteur - F-69367 Lyon cedex 07 - France
Sanofi Pasteur Inc. – Discovery Drive – Swiftwater, PA 18370-0187 – USA – www.sanofipasteur.com
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