Takeda Pharmaceutical Company has announced the cancellation of its planned launch in Japan of Vaxem Hib, a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib).
This is the result of the discontinuation of the manufacture and supply of Vaxem Hib worldwide by the manufacturer GlaxoSmithKline (GSK) as part of an ongoing process by GSK to optimize its worldwide manufacturing footprint. This decision is accompanied by the termination of the distribution agreement with Takeda for Japan and discontinue manufacturing and supply of Vaxem Hib to Takeda. GSK is the only supplier of this vaccine to Takeda.
In January 2016, the Japanese Ministry of Health, Labour and Welfare approved Takeda’s New Drug Application (NDA) for Vaxem Hib in children aged from 2 months to under 5 years of age, to prevent infections caused by Hib. Hib frequently inhabits the nasopharynx (nose and throat) of individuals and can spread to other parts of the body, causing life threatening illness such as meningitis, pneumonia, or sepsis, particularly in young children. Hib meningitis can be fatal or result in long term disability, but can be prevented through immunization.
Takeda developed the vaccine for Japan in collaboration with Novartis and then GSK, following GSK’s acquisition of Novartis’ vaccine business in March 2015. Takeda had planned to launch the vaccine in Japan in early 2017. GSK recently made the decision to terminate global production and supply of Vaxem Hib, and subsequently informed Takeda of this decision. Takeda proposed alternatives to GSK to allow the launch of Vaxem Hib to proceed as planned, but GSK deemed these options not feasible.
Takeda remains dedicated to protecting the health of the Japanese population through the provision of important vaccines. Moving forward, Takeda will maintain its focus on vaccine development programs against significant infectious diseases such as dengue, zika, norovirus and polio.