Ready to target GlaxoSmithKline, Sanofi wins 6-in-1 vaccine nod in EU

Sanofi Pasteur is ready to aim its new 6-in-1 infant vaccine at rival GlaxoSmithKline ($GSK). The vaccine maker won European approval for the immunization, putting Glaxo's Infanrix Hexa on notice for the first time since 2005.

That's when Sanofi Pasteur ran into trouble with their predecessor product Hexavac. The European Commission had suspended the product as part of a review of the efficacy of certain hepatitis B immunizations, and the company chose not to reintroduce it. As PMLive reports, the product's official clearance was withdrawn last year.

Meanwhile, Sanofi Pasteur was developing the new version, to be sold as Hexyon in Western Europe by Sanofi Pasteur MSD, a joint venture with Merck's international arm. In Eastern Europe, Sanofi Pasteur will market the shot under the name Hexacima. The vaccine protects infants against diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b.

Sanofi Pasteur will be trying to steal market share from the GSK shot, which is part of its $1 billion-plus Infanrix/Pediarix line. Its argument: Hexyon/Hexacima is easier to use, because it's available as a ready-to-use liquid, rather than a formula needing reconstitution. Sanofi needs that argument to work, because it's counting on the product to drive growth in its vaccines unit.

Meanwhile, GSK has had problems of its own with Infanrix Hexa; it had to recall several lots of the product last year on contamination worries.

- get the Sanofi Pasteur release (PDF)
- see the PMLive story