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

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02/22/2013 | 01:58pm CEST

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.


- 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 [email protected]

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

Stocks mentioned in the article : SANOFI
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Financials (€)
Sales 2017 36 340 M
EBIT 2017 9 642 M
Net income 2017 7 849 M
Debt 2017 5 108 M
Yield 2017 3,70%
P/E ratio 2017 13,37
P/E ratio 2018 17,40
EV / Sales 2017 3,00x
EV / Sales 2018 2,91x
Capitalization 104 B
Duration : Period :
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Average target price 86,2 €
Spread / Average Target 4,8%
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Elias A. Zerhouni President-Global Research & Development
Yong-Jun Liu Head-Global Research & Development
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