Takeda has yet to file for approval of its vaccine candidate to treat dengue, but it now has a €130 million plant and 200 jobs relying on that nod.
The Japanese company today said it has opened the plant Singen, Germany, which will handle formulation, fill, finish and secondary packaging of the dengue vaccine candidate, starting with the packaging line.
Takeda said it selected the Singen site for its first vaccine plant outside of Japan because of employees’ “vast experience in lyophilization technology.” The $143 million sterile manufacturing plant, which was started in 2016, incorporates digital and data-driven technologies with “state-of-the-art” automation, according to Takeda. It has said it expects up to 200 people to work there.
“This new production facility expands Takeda’s global footprint in vaccine manufacturing beyond Hikari, Japan and reinforces our capability to manufacture at scale and meet the global demand that we anticipate for this vaccine,” Rajeev Venkayya, Takeda president of global vaccines, said in a statement.
The World Health Organization estimates the mosquito-borne viral disease, infects 390 million people and results in 20,000 deaths a year.
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The live-attenuated tetravalent dengue vaccine candidate is in Phase 3 trials. Initial data for the candidate, dubbed, TAK-003, was effective in preventing dengue fever caused by any of the four serotypes of the virus. Additional data released this week confirmed its effectiveness.
Rather than take TAK-003 first to regulators in the U.S. and Europe which see few cases of the disease, Takeda has indicated it will seek approvals first in countries where the virus is endemic.
That was the strategy used by Sanofi, which brought its Dengvaxia, the first vaccine approved for dengue, to market in 2015 after two decades of development. The French drugmaker had projected the shot would generate $1 billion in sales once established, but Sanofi has run into issues after determining that Dengvaxia can cause more serious cases of dengue if given to people who haven’t had a prior infection.
The finding led the Philippines, a dengue-endemic country that had launched a national Dengvaxia immunization program, to rescind its approval and demand refunds from the drugmaker.
The FDA earlier this year approved Dengvaxia, but only in a more limited age range than Sanofi had sought. The agency has asked for additional data.