Sanofi won European Union regulatory backing for its six-in-one children’s vaccine, the French drugmaker’s second attempt at such a product and part of a plan to grow in a market dominated by GlaxoSmithKline Plc.
The vaccine, designed to protect children against diseases that include whooping cough and hepatitis B, was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use, Sanofi said in a statement today. The European Commission, the 27-nation EU’s executive arm, usually follows the panel’s recommendation.
Sanofi’s new vaccine will compete with Glaxo’s Infanrix Hexa, one of several Infanrix products sold by the U.K. competitor. Infanrix garnered 775 million pounds ($1.2 billion) in total worldwide sales last year. The EMA had in 2005 suspended the marketing authorization for Hexavac, a previous Sanofi version of such a shot, over doubts on the protection provided by its hepatitis B component.
“Right now, Glaxo has a monopoly in this area,” Eric Le Berrigaud, an analyst at Bryan Garnier & Co. in Paris, said in a telephone interview before the CHMP opinion was announced.
Shares in Sanofi traded 1.6 percent higher at 72.35 euros at 1:07 p.m. in Paris, where the drugmaker is based.
Sanofi’s new product is the only fully liquid and ready-to-use six-in-one children’s vaccine, meaning it doesn’t need to be reconstituted before injection, making the shot easier for doctors than the Glaxo one, according to Paris-based Sanofi. In clinical studies, it was compared to different vaccines already on the market, including Infanrix Hexa, and showed a “similar high immunogenicity profile for all antigens,” Sanofi Pasteur, the French drugmaker’s vaccine division, said in e-mailed comments yesterday.
In Europe, the new vaccine will be sold under two different brand names, Sanofi Pasteur said. In western Europe, it will be marketed by Sanofi Pasteur MSD, a joint venture between Merck & Co. and Sanofi Pasteur, under the brand name Hexyon. In eastern Europe it will be marketed only by Sanofi Pasteur, under the brand name Hexacima, the company said.
The new vaccine is expected to be a “key growth driver” for Sanofi Pasteur this year, Olivier Charmeil, the division’s head, said during a Feb. 7 conference call with analysts.
The new vaccine also protects against diphtheria, tetanus, poliomyelitis and invasive infections caused by Haemophilus influenzae type b, or HIB. HIB is a bacterium that can cause a wide range of diseases in infants, including meningitis and pneumonia.
Sanofi Chief Executive Officer Chris Viehbacher is developing new products to make up for lost sales from generic competition to some of Sanofi’s top-selling medicines, such as the blood-thinner Plavix and Avapro, a treatment for hypertension. Excluding the new children’s vaccine, Sanofi obtained nine regulatory approvals over the past year, for medicines such as Zaltrap, to treat cancer, and Aubagio, a treatment for multiple sclerosis, the company said Feb. 7.