KONSTANZ, Germany & OSAKA, Japan - Wednesday, November 30th 2016 [ME NewsWire]
- Decision follows the successful initiation of TIDES, the global Phase 3 clinical trial to evaluate the efficacy of a two-dose schedule of Takeda’s dengue vaccine candidate
- 40% of the world’s population lives under the threat of the dengue virus
- Manufacturing plant is major step towards meeting important unmet needs in dengue prevention
“This manufacturing plant investment reinforces Takeda’s strong support for our global vaccine strategy in general, and dengue in particular. The new plant will provide millions of people with access to a medicine that addresses a huge unmet medical need. It underlines our commitment to improve the lives of people worldwide,” says Dr. Thomas Wozniewski, Global Manufacturing & Supply Officer at Takeda.
“Our colleagues in Singen have vast experience in lyophilisation technology, which is key for the manufacturing process of Takeda’s dengue vaccine finished product,” notes Thomas Wozniewski. Initial construction activities will start immediately, and the facility should be ready for production in 2019.
On September 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 3 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.
Dr. Rajeev Venkayya, President of Takeda Vaccines, adds “This dengue vaccine production facility is another strong indication of Takeda’s long-term commitment to vaccines. 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 U.S. 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.”
About the Dengue Vaccine Candidate (TAK-003)
Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four vaccine viruses. Takeda’s dengue vaccine is being developed to support the protection of populations and individuals at risk for dengue across geographies whether or not they have had previous exposure to dengue virus, including: children and adults, travelers and those living in endemic areas.
About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
Additional information about Takeda is available through its corporate website, www.takeda.com.
Takeda Pharmaceutical Company Limited
Tsuyoshi Tada, +81 (0) 3-3278-2417