Hexyon/Hexacima 6-in-1 pediatric vaccine approved in Europe

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission approved Sanofi Pasteur’s 6-in-1 pediatric vaccine HexyonTM/Hexacima® (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age.

HexyonTM/Hexacima® is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

The new vaccine will be commercialized under the brand name HexyonTM in Western European countries* by Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, and under the brand name Hexacima® in Eastern European countries by Sanofi Pasteur.

“Hexyon/Hexacima ready-to-use, 6-in-1 pediatric vaccine will raise the standard of care of vaccination for millions of children. It reduces the number of vaccination visits for infants and it is more convenient for parents to complete the recommended vaccination schedule and thus better protect their children against six major childhood diseases,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “We will introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs.”

Key benefits of HexyonTM/Hexacima® vaccine:

• HexyonTM/Hexacima® is a fully liquid, ready-to-use vaccine; no reconstitution is needed prior to administration, which improves convenience for healthcare professionals. It is available in vial and pre-filled syringe presentations.
• By combining six vaccines into one, HexyonTM/Hexacima® reduces the number of injections, which improves comfort and vaccination compliance for infants.
• The use of acP (acellular pertussis) antigens and IPV (inactivated poliovirus vaccine) improves safety and reduces reactogenicity as compared to wcP (whole cell pertussis)-containing vaccines and OPV (oral polio vaccine).

The EC decision follows the European Medicines Agency recommendation supported by the results of multi-center clinical studies involving approximately 5,000 infants. Phase III clinical studies comparing HexyonTM/Hexacima® to licensed combination vaccines demonstrated that HexyonTM/Hexacima® is safe and induces a robust immune response against all six targeted diseases.

HexyonTM/Hexacima® complements Sanofi Pasteur’s product family of acP-IPV (acellular pertussis vaccine, inactivated poliovirus vaccine) combination vaccines. The new 6-in-1 vaccine will be available in international markets under the trade name Hexaxim®. To date, more than 180 million doses of Sanofi Pasteur’s acP-IPV containing vaccines have been distributed in over 100 countries and have been included in the national immunization programs in over 30 countries. HexyonTM/ Hexacima® combines the same antigens included in the well-established vaccines Tetraxim®/Tetravac® (DTaP-IPV vaccine) and Pentaxim®/ Pentavac® (DTaP-IPV-Hib vaccine) with Sanofi Pasteur’s new hepatitis B antigen.

* France, Germany, UK, Spain, Italy, Belgium, Netherlands, Austria, Portugal, Switzerland, Norway, Sweden, Denmark, Finland, Ireland, Greece, Iceland, Luxembourg, Liechtenstein