Pharmaceutical

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. Initial funding from BARDA, which is a division of the Office …

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited [TSE:
4502
], (“Takeda”) today announced that BARDA, the Biomedical
Advanced Research and Development Authority, has selected Takeda’s
Vaccine Business Unit to develop a vaccine to support the Zika response
in the US and affected regions around the world. Initial funding from
BARDA, which is a division of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the US Department of Health and
Human Services, is for $19.8 million to cover the vaccine development
through Phase 1, with potential funding of up to $312 million if
ASPR/BARDA exercises all options to take the vaccine through Phase 3
trials and filing of the Biologics License Application (BLA) in the US.
On February 1, 2016, the World Health Organization declared the Zika
outbreak to be a Public Health Emergency of International Concern. On
February 8, 2016 the Centers for Disease Control and Prevention (CDC)
elevated its Zika response efforts to its highest response level, Level
1. There is no vaccine or medicine for Zika2, and infection
during pregnancy can cause a serious birth defect called microcephaly
and other severe fetal brain defects. Current research suggests
that Guillain-Barre syndrome (GBS), which is an uncommon sickness of the
nervous system, is strongly associated with Zika; however, only a small
proportion of people with recent Zika virus infection get GBS. Many
people infected with Zika will have no symptoms or mild symptoms that
last several days to a week. The virus has spread in recent years into
more than 60 countries and territories including the US.
Dr. Rajeev Venkayya, Corporate Officer and President of the Global
Vaccine Business Unit at Takeda, said: “The Zika emergency demands swift
action by governments, public health agencies, medical and scientific
communities, industry and others, and partnerships are essential for
success. Working with BARDA, Takeda is deploying its world-class
expertise and capabilities in vaccine development for emerging
infectious diseases, and our outstanding team and manufacturing
facilities in Hikari, Japan. This Zika vaccine program joins our work in
dengue, norovirus, our partnership with the Japanese Government on
pandemic influenza, and the recently announced partnership with the Bill
& Melinda Gates Foundation to help eradicate polio. These efforts to
develop a vaccine against the Zika virus reinforce Takeda’s commitment
to the health of people everywhere, including the most vulnerable
populations that are threatened by Zika.”
Given the Japanese Government’s commitment to preparedness for outbreaks
of infectious diseases, recently reinforced by Prime Minister Abe at the
G7 Summit in Ise-Shima, Japan, Takeda is in discussions with the Cabinet
Secretariat of the Prime Minister Office regarding potential
participation of Japanese health agencies in this collaboration. Takeda
is working with ASPR/BARDA and the Japanese Government to explore these
opportunities further.
Under the agreement, Takeda will develop an inactivated, adjuvanted,
whole Zika virus vaccine. The objectives of the first stage of the work
include developing and producing the investigational vaccine and
completing pre-clinical studies, submission of an Investigational New
Drug Application (IND) to the US Food and Drug Administration, and
execution of a Phase 1 clinical trial. Manufacturing of the vaccine will
occur at Takeda’s facilities in Hikari, Japan.
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have
transformed global public health. For 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.
1http://www.who.int/emergencies/zika-virus/en/
2http://www.cdc.gov/zika/

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