Business Wire

Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

Share

Takeda Pharmaceutical Company Limited(TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.

“Submission of regulatory filings for our dengue vaccine candidate, TAK-003, marks an important development for people who are living in or traveling to communities burdened by the threat of dengue,” said Derek Wallace, VP, Dengue Global Program Leader at Takeda. “Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support evaluation of our submissions and achieve access for TAK-003.”

Takeda is participating in the EMA’s first-ever parallel assessment of a medicinal product for use in the European Union (EU), and through the EU-M4all (previously Article 58) procedure for countries outside of the EU. Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. Takeda is also seeking approval of TAK-003 in dengue-endemic countries that are not participating in the EU-M4all procedure.

Regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. Takeda intends to present and publish details of the 36-month data at a scientific meeting and in a peer-reviewed journal this year.

Takeda also intends to submit regulatory filings in the United States, followed by additional countries in Asia and Latin America.

EU-M4all1

EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. Through the EU-M4all procedure (previously known as the Article 58 procedure), the EMA, in cooperation with the World Health Organization (WHO), can provide scientific opinion on medicines and vaccines for public health priority diseases that are intended for markets outside of the EU.

About 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.2 Clinical Phase 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, which persisted through 48 months after vaccination, and the vaccine was found to be generally safe and well tolerated.3 Thepivotal Phase 3 TIDES trialmet its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) at 12 months follow-up and all secondary endpoints at 18 months follow-upfor which there were a sufficient number of dengue cases, including VE against hospitalized dengue and VE in baseline seropositive and baseline seronegative individuals.4,5 Efficacy varied by serotype. The results demonstrated TAK-003 was generally well tolerated, and there have been no important safety risks observed to date.

About the Phase 3 TIDES (DEN-301) Trial

The double-blind, randomized, placebo-controlled Phase 3 TIDES trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents.4 The TIDES trial is Takeda’s largest interventional clinical trial to date and enrolled over 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas. Study participants were randomly assigned to receive either TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and Day 90.4 The study is comprised of five parts. Part 1 and the primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 15 months after the first dose (12 months after the second dose).4 Part 2 continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and disease severity, including VE against hospitalized dengue.4 Part 3 is evaluating VE and long-term safety by following participants for an additional two and a half to three years.6 Part 4 will evaluate safety for 13 months following booster vaccination and Part 5 will evaluate long-term safety for one year after completion of Part 4.6

The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.4 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.

About Dengue

Dengue is the fastest spreading mosquito-borne viral disease and was one of the WHO’s top 10 threats to global health in 2019.7,8 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.9 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.

Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental United States and Europe.10,11 Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year.10,12 The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.10

Takeda’s Commitment to Vaccines

Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.13 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, COVID-19, Zika and norovirus. Takeda’s 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 discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). 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. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/ reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

###


1The European Medicines Agency. Medicines for use outside the EU — EU-M4all. July 2020. Retrieved March 2021.

2 Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.

3Tricou, V, Sáez-Llorens X, et al. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020. doi:10.1016/S0140-6736(20)30556-0.

4 Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. N Engl J Med. 2019; 2019;381:2009-2019.

5 Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomized, placebo controlled, phase 3 trial. Lancet. 2020. 2020;395:1423-1433.

6 ClinicalTrials.Gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved March 2021.

7 World Health Organization. Factsheet. Dengue and Severe Dengue. April 2019. Retrieved February 2021.

8 World Health Organization. Ten threats to global health in 2019. 2019. Retrieved February 2021.

9 Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.

10 Knowlton K, et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved February 2021.

11 Chan E, et al. Using web search query data to monitor dengue epidemics: a new model for neglected tropical disease surveillance. PLoS Negl Trop Dis. 2011;5:e1206.

12 Centers for Disease Control and Prevention. About Dengue: What You Need to Know. May 2019. Retrieved February 2021.

13 UNICEF. Vaccination and Immunization Statistics. 2019. Retrieved February 2021.

Contact information

Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media Outside Japan
Rachel Wiese
rachel.wiese@takeda.com
+1 917-796-8703

About Business Wire

Business Wire
Business Wire



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

BridgeTower Capital Launches Security Token Pre-Offering and Announces Global Expansion With Key Partners15.4.2021 18:00:00 CEST | Press release

BridgeTower Capital, a tokenized global private equity firm, has launched a private Security Token Pre-Offering (STO) culminating 12 months of work to purposefully assemble a team of world-class partners to participate in the blockchain infrastructure and services marketplace in the rapidly growing world of decentralized finance (DeFi). BridgeTower also announced it has formed a Zurich-based entity to further expand its current offering of blockchain infrastructure products and services. BridgeTower launched its Private -STO campaign earlier this week, which provides an opportunity for accredited investors to purchase shares in the company in the form of a digital security. BridgeTower has received active participation already and is seeking to raise $200 million in this initial raise. “We are seeing a global confluence of public and private digital finance markets being fueled by the adoption of blockchain technologies. This is creating unique opportunities for those who can assemble

Cryptology Asset Group p.l.c. successfully completes a share capital increase and sale of treasury shares and reviews options for financing further growth15.4.2021 16:49:00 CEST | Press release

Cryptology Asset Group p.l.c. (ISIN: MT0001770107; Ticker: CAP), a leading European investment company for blockchain- and crypto-related business models, has successfully completed its cash capital increase by issuing 128,375 new shares and the additional sale of the entire amount of 31,625 treasury shares to institutional investors. At a fixed price of EUR 200.00 per share each, the Company will receive total gross proceeds of EUR 32.0 million, which will be used to invest in new portfolio companies from the Cryptology pipeline. The Company is also exploring the possible acquisition of crypto assets, such as Bitcoin, as part of its treasury management strategy. To finance further growth, Cryptology is also currently reviewing various options to raise additional capital, such as through the issuance of a convertible or a straight bond. ICF BANK AG has been commissioned to conduct a market review. Management will make the final financing decision based on investor feedback and the prev

Cryptology Asset Group p.l.c. resolves a cash capital increase and sale of treasury shares15.4.2021 16:45:00 CEST | Press release

The Board of Directors of Cryptology Asset Group p.l.c. (ISIN: MT0001770107; Ticker: CAP) today resolved to increase the share capital of the Company by 128,375 new shares and to sell 31,625 treasury shares which is the entire position Cryptology holds of own shares after the buyback done over the last months. Shareholders' subscription rights to the new shares and the treasury shares are excluded. The Company has entered into binding subscription agreements for the entire amount of in total 160,000 shares with several institutional investors. Closing of the transaction is expected for end of April 2021. The capital increase will be carried out in cash contributions and by partially utilizing the existing authorized capital. The share capital of the Company is to be increased from EUR 2,732,500 to EUR 2,860,875 by issuing 128,375 new bearer shares of the Company ("New Shares"). The New Shares will be issued with a pro rata amount of capital stock of EUR 1.00 per share and with full div

A Digital Transformation: Mary Kay Inc. Launches Immersive Virtual Experience Platform Suite 13 TM15.4.2021 15:03:00 CEST | Press release

Global beauty brand Mary Kay Inc. and its Mary Kay Global Design Studio present Suite 13TM, an innovative virtual beauty experience that leverages the use of virtual reality to digitize Mary Kay's first virtual pop-up showroom. Designed with the latest virtual reality technology, the new Suite 13TM offers Mary Kay Independent Beauty Consultants and their customers a 360-degree, 3D beauty experience where users can virtually browse the beauty brand’s portfolio of skin care as well as explore the company and its founder Mary Kay Ash’s history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005306/en/ The new Suite 13™ offers Mary Kay Independent Beauty Consultants and their customers a 360-degree, 3D beauty experience. (Photo: Mary Kay Inc.) The new Suite 13TM invites users to tour through virtual “rooms”. Upon entering the “Lobby”, users can learn about the Company’s global legacy. The other virtual rooms include the “P

Conviva Works With ServiceNow to Provide Next Generation Customer Service for Streaming Customers15.4.2021 15:00:00 CEST | Press release

Conviva, the intelligence cloud for streaming media, today announced that its streaming insights data will be integrated with ServiceNow telecom and media industry solutions. This new integration will enable streaming providers to offer more reliable streaming services and personalized customer care experiences to drive user acquisition, reduce operational costs and increase customer lifetime value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005156/en/ Conviva and ServiceNow Provide Next Generation Customer Service For Streaming Customers (Graphic: Business Wire) Conviva’s integration with ServiceNow extends ServiceNow’s offerings within the telecom and media industry and will help streaming customers to automate proactive case creation and ticket generation to identify and diagnose incidents across the entire video delivery supply chain. Adding this additional layer of automation to root cause analysis delivers im

Thales IoT SAFE to Secure Cloud Connectivity for New Internet of Things Services in Canada15.4.2021 15:00:00 CEST | Press release

Thales technology is at the heart of a new Canadian IoT project that is enabling instant, secure and scalable cloud connectivity for SIM/eSIM-enabled IoT. Working alongside TELUS, a leading Canadian wireless network operator, and the Canadian Internet Registration Authority (CIRA), the project’s certification partner, Thales is supplying SIMs and the IoT server, both compliant with the GSMA IoT SAFE specifications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005017/en/ (Photo: Thales) The Thales IoT SAFE service offers an interoperable framework enabling swift deployment of IoT applications. Delivered in a plug & play SaaS mode, it benefits minimal integration effort. It creates a scalable and automatic environment for cloud data security of SIM-equipped devices with a remote management feature. TELUS continues its IoT expansion with devices across Canada, offering enterprises an innovative system that eliminates th

First Patient Enrolled in PROTECT IV Randomized Controlled Trial of Impella15.4.2021 14:03:00 CEST | Press release

Abiomed (NASDAQ:ABMD) announced today that the first patient has been enrolled in PROTECT IV, a large, prospective, multi-center randomized controlled trial (RCT) that is designed to provide the level of clinical evidence needed to achieve a Class I guideline recommendation for Impella in high-risk percutaneous coronary intervention (HRPCI). The first patient was enrolled at Ascension St. John Hospital in Detroit by Dr. Ted Schreiber, chief of cardiology at Ascension St. John Macomb-Oakland Hospital and Dr. Amir Kaki, interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210415005234/en/ Impella Clinical Pathway to Class I Guideline (Graphic: Business Wire) The two-arm trial will compare the benefits of HRPCI with Impella versus HRPCI without Impella support. The primary endpoint of the study is the composite of all-cause deat

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