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GSK ends Vaxem Hib production, costing Takeda a planned launch in Japan

may 10, 2017 By fiercepharma
Tag: GSK , vaccine

Takeda’s plan to launch a Haemophilus influenzae type B (Hib) vaccine in Japan has ended in smoke as manufacturer GlaxoSmithKline has terminated production of Vaxem Hib.

Takeda announced the termination of the Japanese launch of Vaxem Hib in a release, citing supply withdrawal from GSK. A GSK media aide confirmed the decision with FiercePharma and said that it's “part of the ongoing process to integrate our GSK and legacy Novartis product portfolios and to optimize our manufacturing footprint.” 

Vaxem Hib, manufactured at GSK's vaccines manufacturing site in Rosia, Italy, is currently marketed only in South Korea. The media aide said that “GSK is working with key stakeholders to ensure a smooth phasing out,” while also stressing that the withdrawal will have "no material impact on our business.”

Takeda acquired the rights to develop and commercialize Vaxem Hib in Japan through a deal with Novartis in May 2009. In March 2015, the vaccine, together with the contract, transferred to GSK in an asset swap through which the London drugmaker divested its oncology business for the Swiss pharma’s global vaccines business.

In January 2016, Japan’s health authorities approved Takeda’s application for Vaxem Hib in children aged 2 months to under 5 years of age. The company was ready to go ahead with its official launch until GSK recently decided to discontinue global production. GSK is the only manufacturer of the vaccine.

Takeda proposed other options, “but GSK deemed these options not feasible,” said Takeda in the release. 

This is not the first time GSK has pulled the plug on a Hib vaccine. Last October, the British drugmaker announced its decision to stop manufacturing MenHibrix, a shot that protects against meningococcal groups C and Y, and Hib, in the U.S.

With the move, GSK will continue to supply Hib vaccines including Infanrix and Hiberix. The latter vaccine first won U.S. approval in August 2009 as a fourth booster shot during a Hib vaccine shortage. In January 2016, the shot picked up an expanded approval to become a full-series, four-dose vaccination series.

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