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SANOFI : EMA Recommends Approval Of Sanofi Pediatric Vaccine Hexyon/Hexacima 6-in-1

02/22/2013 | 07:58am US/Eastern

PARIS--The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended market approval for Sanofi Pasteur's 6-in-1 pediatric vaccine, French drugs giant Sanofi (>> SANOFI) said Friday.

MAIN FACTS:

- Hexyon/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 Hexyon 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.

- The vaccine "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.

-Hexyon/Hexacima 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 Hexyon/Hexacima to licensed combination vaccines demonstrated that HexyonTM/HexacimaTM is safe and induces a robust immune response against all six targeted diseases.

-Write to Mimosa Spencer at mimosa.spencer@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

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