European Medicines Agency recommends approval of Hexyon/Hexacima 6-in-1 pediatric vaccine

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended market approval for Sanofi Pasteur’s 6-in-1 pediatric vaccine HexyonTM/HexacimaTM (DTaP-IPV-Hib-HepB vaccine).

HexyonTM/HexacimaTM 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 HexacimaTM in Eastern European countries by Sanofi Pasteur.

“Availability of 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. “Upon licensure, we intend to introduce Hexyon/Hexacima vaccine in countries that are looking for improved and effective solutions for public immunization programs.”

Key benefits of HexyonTM/HexacimaTM vaccine:

• HexyonTM/HexacimaTM 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/HexacimaTM 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).

Upon licensure, HexyonTM/HexacimaTM would be indicated for primary and booster vaccination of infants from six weeks of age in accordance with official recommendations.

The CHMP positive opinion is supported by results of multi-center clinical studies involving approximately 5,000 infants. Phase III clinical studies comparing HexyonTM/HexacimaTM to licensed combination vaccines demonstrated that HexyonTM/HexacimaTM is safe and induces a robust immune response against all six targeted diseases.

HexyonTM/HexacimaTM 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/ HexacimaTM 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