OSAKA, Japan -Tuesday, November 28th 2017 [ AETOS Wire ]
Takeda’s investigational Zika virus vaccine candidate (TAK-426) progresses into Phase 1 clinical trial
The clinical trial (ZIK-101) will evaluate safety and immunogenicity of
TAK-426 in 240 subjects between the ages of 18 and 49 across the
continental U.S. and U.S. territories
Takeda’s Zika program is
funded 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
(BARDA), under Contract No. HHSO100201600015C
(BUSINESS WIRE)--
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20171128005803/en/
Contacts
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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