Takeda’s Zika Vaccine Candidate Receives U.S. FDA Fast Track Designation

Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions and that fill an unmet medical need. The Fast Track process allows more frequent interactions with the FDA, rolling reviews of the Biologic License Application (BLA), and eligibility for a priority review if relevant criteria are met.

Zika can cause congenital Zika syndrome (CZS), including microcephaly and other congenital brain abnormalities, in infants born to mothers infected during pregnancy.¹ The virus has also been associated with neurological complications, including Guillain-Barre Syndrome (GBS), in the general population. The Zika virus has spread in recent years to more than 84 countries, territories or subnational areas, including the U.S.² There is currently no vaccine or medicine for Zika.³

“We recognize the public health threat posed by the Zika virus,” said Laurence De Moerlooze, PhD, Global Zika Program Lead. “As soon as Takeda received funding from BARDA, we mobilized a team and prioritized development of this vaccine candidate, initiating a Phase 1 trial within 15 months of contract signature. With Fast Track designation, the ongoing support of BARDA, and the abilities of our organization, we are confident that we will continue to make expedient progress. We look forward to continuing to work closely with the FDA and BARDA, as well as other health authorities across the world, on the development of this important vaccine candidate.”

Takeda’s Zika vaccine candidate is currently being studied in a Phase 1 trial (ZIK-101) under a U.S. Investigational New Drug (IND) application. If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.

Beyond Zika, Takeda is pursuing several vaccine programs to address high-priority infectious diseases, including dengue, norovirus and polio. Takeda’s dengue vaccine candidate, TAK-003, was also granted Fast Track designation and is currently being evaluated in a pivotal Phase 3 efficacy study, with initial data expected this year.

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 Zika
Zika is caused by a virus transmitted primarily by Aedes aegypti mosquitoes.¹ Symptoms of Zika may include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache.¹ According to the World Health Organization (WHO), Zika virus can cause serious birth defects called congenital Zika syndrome, including microcephaly.¹ Zika is also a cause of an uncommon sickness of the peripheral nervous system called Guillain-Barré syndrome. ¹ Links to other complications are also being investigated.¹ In February 2016, 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.⁵ Although WHO has since declared an end to the PHEIC,⁶ Zika remains a public health concern.⁴

About Clinical Trial ZIK-101
ZIK-101 is a randomized, placebo-controlled, double-blind trial designed to evaluate the safety and immunogenicity of Takeda’s investigational Zika vaccine candidate (TAK-426) in 240 male and female subjects between the ages of 18 and 49.⁷ The Phase 1 trial is designed to assess several dose levels of the vaccine candidate to support the progression of TAK-426 into future studies.⁷ The trial is taking place in the continental U.S. and U.S. territories and being conducted under a U.S. Investigational New Drug (IND) application.⁷
(Clinicaltrials.gov identifier: NCT03343626)

Takeda’s Commitment to Vaccines
Vaccines prevent more than two 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, 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, 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 neuroscience therapeutic area plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries.
For more information, visit https://www.takeda.com/newsroom/.

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.

References

1. World Health Organization. Zika Virus Fact Sheet. Retrieved January 2018.
2. World Health Organization. Zika Virus and Complications: 2016 Public Health Emergency of International Concern. Retrieved January 2018.
3. Centers for Disease Control and Prevention. Zika Virus: About Zika. Retrieved January 2018.
4. World Health Organization. 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. Retrieved January 2018.
5. Centers for Disease Control and Prevention. CDC Emergency Operations Center Moves to Highest Level of Activation for Zika Response. Retrieved January 2018.
6. World Health Organization. Fifth meeting of the Emergency Committee under the International Health Regulations (2005) regarding Microcephaly, Other Neurological Disorders and Zika Virus. Retrieved January 2018.
7. ClinicalTrials.gov. Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants. Retrieved January 2018.
8. UNICEF. Immunization Facts and Figures April 2013. Retrieved January 2018.

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Contact information

Takeda Pharmaceutical Company Limited
For media outside of Japan:
Amy Atwood, +1-617-444-2147
amy.atwood@takeda.com
or
For Japanese media:
Kazumi Kobayashi, +81 3 3278 2095
kazumi.kobayashi@takeda.com