Business Wire

Takeda Unveils New Dengue Vaccine Manufacturing Plant in Germany

Share

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)

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.

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

Data Security Innovator, Secure Channels, Chooses Thales to Provide Key Management and Software Licensing Platform For IoT Security Solution22.1.2020 10:00:00 EETPress release

Thales has announced its encryption key management and software licencing platforms have been chosen by Secure Channels to protect its quantum-resilient encryption keys for its IoT-enabled devices. By using Thales’ key management platform, both companies’ customers will benefit from increased data protection no matter the connected device, even if there is no current security protection in place. In addition, Thales’ software licensing platform will enable easy access to Secure Channels’ cybersecurity software technology for customers and manufacturers, thus ensuring all IoT devices can be protected easily either at source or retrospectively. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200121005189/en/ (Photo: Thales) “Thales’s Sentinel Entitlement Management Software has enabled the first generation of truly secure connected devices,” said Secure Channels Chief Executive Officer Richard Blech. “With the vast increase in

Jefferies to Hold Asia Pacific Trading Day in Support of Australia Wildfires Relief Today, January 2222.1.2020 10:00:00 EETPress release

Jefferies announced that today is the firm’s trading day to support relief efforts caused by the recent wildfires in Australia. Jefferies will offer investors the opportunity to join efforts to assist those affected by the devastation of this event by trading with Jefferies. As previously announced, Jefferies will donate net trading commissions from today, Wednesday, January 22 for all trading in Asia Pacific securities, including equities, fixed income and FX, by the firm’s clients globally. Simultaneously, all of the firm’s global employees will also be given the opportunity to personally donate to the relief effort. Jefferies will match all client trading commissions generated today, as well as match all employee donations from across the firm. The total contribution will then be donated to relief organizations directly involved in the rescue and recovery efforts in Australia. Rich Handler, CEO, and Brian Friedman, President, of Jefferies commented: "All of us at Jefferies, includin

Naspers Limited: Results of the Sale by Naspers Limited of 22 Million N Ordinary Shares of Prosus N.V. Through an Accelerated Bookbuild Offering to Institutional Investors22.1.2020 09:30:00 EETPress release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH OFFERS OR SALES WOULD BE PROHIBITED BY APPLICABLE LAWs and REgulations. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE IN ANY JURISDICTION, INCLUDING THE UNITED STATES, CANADA, AUSTRALIA OR JAPAN. NEITHER THIS ANNOUNCEMENT NOR ANYTHING CONTAINED HEREIN SHALL FORM THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR COMMITMENT WHATSOEVER IN ANY JURISDICTION. Naspers Limited (JSE: NPN; LSE: NPSN) ("Naspers") has sold 22 million N ordinary shares (the "Prosus N Ordinary Shares") in Prosus N.V. ("Prosus"), corresponding to c. 1.4% of the issued Prosus N Ordinary Shares, at a price per Prosus N Ordinary Share of €67.50, resulting in gross proceeds of approximately €1.5 billion for Naspers. The sale was effected through an accelerated bookbuild offering to institutional investors (the "Placin

CollabNet VersionOne and XebiaLabs Combine to Create Integrated Agile DevOps Platform22.1.2020 05:10:00 EETPress release

CollabNet VersionOne (CollabNet), a leading provider for Agile planning and collaborative development, and XebiaLabs, the leader in release orchestration, deployment, and continuous delivery, announced today that the two companies have merged. The combination, which was backed by TPG Capital, unites CollabNet’s upstream Agile planning and enterprise version control functionality with XebiaLabs’ downstream release orchestration and deployment automation capabilities to create an Agile, end-to-end, DevOps platform for enterprises. In connection with the transaction, Ashok Reddy, an accomplished industry veteran and former Broadcom executive, has joined the combined company as CEO. He replaces Flint Brenton, who is stepping aside to focus on family and personal interests after nearly five years of successful stewardship. Derek Langone, current CEO of XebiaLabs, will serve as President of the combined company. Stephen Gregorio, EVP and CFO of XebiaLabs, will serve as the combined company’s

Gilead Sciences to Release Fourth Quarter and Full Year 2019 Financial Results on Tuesday, February 4, 202022.1.2020 01:30:00 EETPress release

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2019 financial results will be released on Tuesday, February 4, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s fourth quarter and full year 2019 financial results and will provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 9634129 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, February 6, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (intern

Bermuda Further Enhances Its International Appeal as Incorporated Segregated Accounts Companies Legislation Comes Into Effect22.1.2020 01:10:00 EETPress release

Bermuda’s Incorporated Segregated Accounts Companies Act 2019 (ISAC Act) came into effect on January 15, 2020, providing multiple industries with yet another compelling reason for choosing to domicile their business on island. The ISAC Act, a stand-alone piece of legislation and a companion statute to the Segregated Accounts Companies Act 2000, further enhances Bermuda’s legislative framework by introducing a new and innovative company structure to cater to the needs of existing and prospective businesses. ISACs enable the creation of corporate group structures to operate multiple businesses or ‘accounts’, each ring-fenced with its own separate legal identity, under one umbrella. As such, each account has the capacity, rights, powers and privileges of a natural person, including the right to enter into contracts with other accounts under the ISAC and with the ISAC itself. There are no limits on the number of accounts an ISAC may establish. This structure not only offers greater flexibi

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