Takeda's Hib vaccine gets Japanese approval

Large office building overlooking water at night

Almost 7 years after licensing it from Novartis, Takeda picked up a regulatory green light from Japan's Ministry of Health, Labour and Welfare for its Haemophilus influenzae type B (Hib) vaccine. The vaccine, Vaxem Hib, is approved for use in children aged two months to under 5 years.

The approval is based on positive results from a Phase III study that pitted Vaxem against an Hib vaccine licensed in Japan. The multicenter, double-blind study involved more than 400 Japanese children, Takeda said in a statement.

In 2009, Takeda acquired the rights to develop and commercialize Vaxem Hib vaccine in Japan, handing over ¥100 million ($844,000) up front. After Novartis ($NVS) closed on its multibillion-dollar asset deal last year that saw it hand its noninfluenza vaccines business over to GlaxoSmithKline ($GSK) in exchange for its oncology unit, GSK now owns Vaxem Hib. The British pharma was already marketing its Hib vaccine, Hiberix, in 78 countries, but until last week, it was only used as a booster in the U.S. to address a shortage.

Before Hib vaccines were available, Hib was the leading cause of pediatric bacterial meningitis. Hib meningitis can be fatal, Takeda said, but can be prevented via immunization.

Takeda has been active in the vaccines space of late, in November closing a $3.3 million equity investment in Belgium's Univercells to use the latter's platform to produce low-cost vaccines. And last May, along with Daiichi Sankyo, Takeda signed a distribution agreement with the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) to distribute one of the institute's seasonal flu shots. However, this was followed by a move to close multiple U.S. vaccine facilities and consolidate them in Cambridge, MA.

- here's the release