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Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.
Takeda Pharmaceuticals Company will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany, the company announced on Nov. 29, 2016. The decision follows the successful initiation of a global Phase III clinical trial to evaluate the efficacy of a two-dose schedule of Takeda’s dengue vaccine candidate. According to the World Health Organization, dengue is the fastest-spreading mosquito-borne viral disease, and 40% of the world’s population lives under the threat of the dengue virus. The plant will help meet important unmet needs in dengue prevention.
“Our colleagues in Singen have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine finished product,” noted Thomas Wozniewski, Global Manufacturing & Supply officer at Takeda, in a press release. Initial construction activities will start immediately, and the facility should be ready for production in 2019.
On Sept. 7, 2016, Takeda vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES). TIDES is now enrolling approximately 20,000 healthy children between the ages of four and 16 years living in dengue-endemic countries in Latin America and Asia. The study is a Phase III double-blind, randomized, placebo-controlled trial of Takeda’s live-attenuated tetravalent dengue vaccine candidate. The study is evaluating the efficacy of the vaccine candidate to protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus. The study is also evaluating vaccine safety and immunogenicity, with two doses of the vaccine candidate or placebo administered 90 days apart.
“This dengue vaccine production facility is another strong indication of Takeda’s long-term commitment to vaccines,” said Dr. Rajeev Venkayya, president of Takeda Vaccines, in the press release. “The progress of the dengue TIDES clinical trial, our partnership with the Bill & Melinda Gates Foundation to eradicate polio, the recent initiation of the world’s first field efficacy trial for a norovirus vaccine, and our work with the US Government to develop a Zika vaccine, together demonstrate how Takeda is dedicated to developing and providing vaccines to protect people in need wherever they are.”