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Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate

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Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial, approximately 15 months after Takeda received a contract to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).1

The randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the investigational vaccine candidate in 240 male and female subjects between the ages of 18 and 49. The Phase 1 trial also will assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.2 The trial will take place in the continental U.S. and U.S. territories and is being conducted under a U.S. Investigational New Drug (IND) application.

“We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda. “This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”

Takeda was selected by BARDA in September 2016 to develop a vaccine to support the Zika response effort in the U.S. and affected regions around the world.

In recent years, the Zika virus has had a devastating impact, spreading across more than 84 countries, territories or subnational areas, including the U.S.3 In February 2016, the World Health Organization (WHO) declared the Zika outbreak to be a Public Health Emergency of International Concern (PHEIC)4 and the Centers for Disease Control and Prevention (CDC) elevated its response efforts to its highest level (Level 1).5 Although WHO has since declared an end to the PHEIC,6 Zika continues to pose a significant threat to public health, especially for pregnant women, and a vaccine is still needed.

Given the public health threat posed by Zika, Takeda mobilized a multifunctional team immediately following signature of the contract with BARDA and has prioritized all aspects of the development program, enabling the Phase 1 trial to start within 15 months of funding.1 Initial data from ZIK-101 are expected in 2018, and, if available Phase 1 data support it, Takeda will work toward initiating Phase 2 studies as soon as possible.2

“BARDA remains committed to making available safe and effective Zika vaccines,” said Rick Bright, Ph.D., BARDA Director. “Takeda’s Phase 1 clinical study is an important step toward this goal.”

Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio.

Acknowledgment of Federal Funding
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.

About Takeda’s Zika Virus Vaccine Candidate (TAK-426)
Takeda’s Zika virus vaccine candidate (TAK-426) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine. The candidate is being developed as part of a broader effort to prevent the spread of the Zika virus in susceptible populations around the world.

Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health.7 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, norovirus and polio. 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.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for 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 its 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.

Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; the transaction may not be consummated; the anticipated benefits of the transaction may not be realized; the transaction could disrupt relationships with employees, licensees, customers and other business partners or governmental entities; future sales could be adversely affected by competition or other factors; and integration costs may exceed current expectations. In addition, the combined business could be adversely affected by industry, economic or political conditions outside of BARDA or Takeda’s control, including general economic conditions in Japan, the United States and worldwide; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither BARDA nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

1 Takeda Newsroom: Takeda to develop Zika Vaccine with up to $312 million in funding from US Government. Accessed November 2017 from https://www.takeda.com/newsroom/newsreleases/2016/Takeda-to-develop-Zika-Vaccine-with-up-to-$312-million/
2 ClinicalTrials.gov. Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants. 2017. Accessed November 2017 from https://www.clinicaltrials.gov/ct2/show/NCT03343626?term=ZIK-101&recrs=ab&rank=1
3 WHO Zika virus and complications: 2016 Public Health Emergency of International Concern. Accessed November 2017 from http://www.who.int/emergencies/zika-virus/en/
4 WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations. Accessed November 2017 from http://www.who.int/mediacentre/news/statements/2016/1st-emergency-committee-zika/en
5 CDC Emergency Operations Center moves to highest level of activation for Zika response. Accessed November 2017 from https://www.cdc.gov/media/releases/2016/s0208-zika-eoca-activation.html
6 Fifth meeting of the Emergency Committee under the International Health Regulations (2005) regarding microcephaly, other neurological disorders and Zika virus. Accessed November 2017 from http://www.who.int/mediacentre/news/statements/2016/zika-fifth-ec/en
7 UNICEF Immunization Facts and Figures April 2013. Accessed November 2017 from https://www.unicef.org/immunization/files/UNICEF_Key_facts_and_figures_on_Immunization_April_2013(1).pdf

Contact information

Takeda Pharmaceutical Company Limited
For media outside of Japan:
Elissa Johnsen
TEL: +1-224-554-3185
elissa.johnsen@takeda.com
or
For Japanese media:
Tsuyoshi Tada
TEL: +81-3-3278-2417
tsuyoshi.tada@takeda.com

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