Takeda Unveils New Dengue Vaccine Manufacturing Plant in Germany
5.11.2019 17:00:00 EET | Business Wire | Press release
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the opening of its new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003. The Singen vaccine plant will be utilized for formulation, fill, finish and secondary packaging of the dengue vaccine candidate starting with the packaging line. Takeda invested more than 130 million Euro and will employ up to 200 employees in the vaccine plant.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191105005718/en/
Takeda senior leaders are joined by honored guests and employees at the grand opening of Takeda’s dengue vaccine manufacturing plant in Singen, Germany. (Photo: Business Wire)
According to the World Health Organization (WHO), dengue is the fastest spreading mosquito-borne viral disease, which is estimated to cause approximately 390 million infections and 20,000 deaths globally each year.2
“This project is one of our most significant investments within our global manufacturing network. We are proud to open this new, state of the art sterile manufacturing plant, which combines a high degree of automation with the most advanced digital and data-driven technologies,” said Thomas Wozniewski, Global Manufacturing and Supply Officer. “Our Singen site has been selected for this investment as our employees have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine candidate.”
“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,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda.
Initial construction activities started at the end of 2016 and the plant is now ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure.
Takeda’s dengue vaccine candidate is currently being investigated in the pivotal Phase 3, multi-centered, global, double blind, randomized, placebo-controlled trial to evaluate the efficacy, safety and immunogenicity of a tetravalent dengue vaccine administered subcutaneously in healthy children aged four to 16 years old. Takeda announced the trial met the primary efficacy endpoint in January 2019. The first interpretable results of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the investigational live-attenuated tetravalent dengue vaccine was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. The TIDES trial is ongoing and additional results will be published later this year, along with results from other Phase 3 studies. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.
About Takeda’s Dengue Vaccine Candidate (TAK-003)
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.3 Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well tolerated.4,5,6,7
About Takeda’s Commitment to Vaccines
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.8 For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, Zika and norovirus. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs. For more information, visit www.TakedaVaccines.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
References
1ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). 2017. Retrieved September 2019.
2World Health Organization. Dengue and Severe Dengue. 2019. Retrieved September 2019.
3Huang, C. Y.-H., et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for Tetravalent Dengue Vaccine (DENVax). PLoS Neglected Tropical Diseases. 2013. Retrieved September 2019.
4Sáez-Llorens, X., Tricou, V., et al. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine: Interim results of a long-term phase 2, randomized, placebo-controlled pediatric trial in Asia and Latin America. The Lancet Infectious Diseases. 2017. Retrieved September 2019.
5Osorio, J.E., et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. The Lancet Infectious Diseases. 2014. Retrieved September 2019.
6Wallace, D. Persistence of neutralizing antibodies one year after two doses of a candidate recombinant tetravalent dengue vaccine in subjects aged from 1.5 to 45 years. Presented at 6th Annual Meeting, American Society of Tropical Medicine and Hygiene. 2015.
7Saez-Llorens, X., et al. Phase II, double-blind, controlled trial to assess the safety and immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and <18 years and living in dengue endemic countries in Asia and Latin America. Presented at 5th Pan-American Dengue Research Network Meeting. 2016.
8World Health Organization. Immunization. 2019. Retrieved September 2019.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191105005718/en/
Contact information
Japanese Media
Kazumi Kobayashi
Kazumi.Kobayashi@takeda.com
+81 (0) 3-3278-2095
Global Manufacturing and Supply
Alexander Kandt
Alexander.Kandt@takeda.com
(office) +41.445.551.605
(mobile) +41.798.934.226
Vaccine Business / Global Media
Rachel Wiese
rachel.wiese@takeda.com
(office) +1.617.444.1452
(mobile) +1 917.796.8703
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 01:10:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of ORZEYFUL marks a new chapter for the narcolepsy type 1 community, as we introduce an entirely new class of medicine that will potentially redefine how this disease is managed and howpeople feel on treatment,” said Julie Kim, president and chief executive officer of Takeda. “We are proud to have discovered and developed this orexin treatment innovation and will bring it to adults living with NT1 as quickly as possible.” NT1 is a rare, chronic neurological disease d
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 23:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
Clinilabs Announces Medical Leadership Appointments5.8.2026 17:05:00 EEST | Press release
Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership, and operational excellence with a track record of execution from first-in-human studies through regulatory
Interactive Brokers Adds Brazilian Futures through Brazil’s B3 Exchange5.8.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that eligible clients outside of Brazil can now trade Brazilian futures in addition to equities through the B3 exchange. Interactive Brokers was the first broker to provide international investors with streamlined, low-cost access to B3. Offering Brazilian futures and equities alongside products across more than 170 markets worldwide underscores IBKR’s commitment to broadening global market access and giving clients efficient, cost-effective ways to diversify through a single, unified platform. Access to B3 provides exposure to one of Latin America’s most active and liquid markets, providing long-term growth potential across multiple sectors and another way for investors to pursue emerging market opportunities. "Global investors deserve seamless, low-cost access to the world's most compelling markets, including emerging economies shaping tomorrow's financial landscape," said Milan Galik, Chief Executive Off
Speech Processing Solutions Launches Philips SpeechLive Legal AI Assistant for Faster, More Accurate Legal Document Creation5.8.2026 16:37:00 EEST | Press release
Speech Processing Solutions, the global leader in AI-assisted professional dictation and documentation solutions sold under the Philips brand, today announced the Philips SpeechLive Legal AI Assistant. The new solution transforms voice recordings, dictation and uploaded sources into structured, ready-to-review legal documents, helping legal professionals work faster while retaining control of the final draft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805997413/en/ The new Philips SpeechLive Legal AI Assistant is designed for turning conversations into ready-to-review legal document drafts. SpeechLive Legal significantly reduces the time needed to transform voice input into structured legal documentation, delivering consistent and high-quality drafts and featuring SpeechLive's built-in integrations with leading case management platforms such as Actionstep, Clio, iManage and NetDocuments, supporting existing billing, e
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom