Takeda Initiates World’s First Norovirus Vaccine Field Trial

Vaccine candidate will target the leading cause of acute
gastroenteritis around the globe

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:
), (“Takeda”) today announced that it has dosed the first
subject in a Phase 2b field efficacy trial of Takeda’s norovirus vaccine
candidate (TAK-214), the only norovirus vaccine candidate in human
clinical trials.

The Phase 2b, double-blind, randomized, placebo-controlled trial
involves healthy male or female adults aged 18 – 49 years. It will
evaluate the efficacy of intramuscular administration of Takeda’s
norovirus vaccine candidate against moderate or severe acute
gastroenteritis (AGE) due to norovirus, a common intestinal infection
marked by watery diarrhea, vomiting, abdominal cramps, nausea and
sometimes fever that may lead to clinically significant dehydration.1,2

Norovirus is recognized as the leading cause of acute gastroenteritis
across the age spectrum.3 It is estimated that norovirus
causes nearly 700 million cases of illness3 with significant
morbidity and social burden worldwide. More than 200,000 deaths per year
are estimated to result from norovirus illness, primarily in low-income

“We are excited to be on the frontline of development of a vaccine
against norovirus,” said Rajeev Venkayya, MD, President of Takeda
Vaccines. “The progress of our norovirus program, along with our efforts
in dengue, polio and hand foot and mouth disease, demonstrates our
commitment to tackling important infectious diseases that affect
populations everywhere.”

The vaccine candidate uses virus-like particle (VLP) antigens, which are
proteins that precisely mimic the outer surface of norovirus. The
vaccine includes antigens from genotypes GI.1 and GII.4, to represent
both of the genogroups that cause the majority of human illness.
Virus-like particle vaccines against human papilloma virus and hepatitis
B virus have been licensed by major regulatory bodies including the U.S.
Food and Drug Administration,5,6 the European Medicines Agency7,8
and the Japanese Ministry of Health, Labour and Welfare.9
Results from Phase 1 and Phase 2 studies of Takeda’s norovirus vaccine
candidate showed the vaccine is generally well-tolerated and was
associated with a reduction in disease symptoms and severity in a human
challenge study, which evaluated healthy adults’ responses following
exposure to live norovirus.

“Together with our collaborators, Takeda has dedicated a substantial
scientific effort to understand the best ways to prevent norovirus
illness through vaccination,” said Robert Goodwin, PhD., Vice President
and Global Norovirus Program Head for Takeda Vaccines. “This trial moves
us one step closer to putting an important tool for prevention in the
hands of individuals, families and public health systems around the

About the Norovirus Vaccine Candidate (TAK-214)

The norovirus intramuscular GI.1 and GII.4 VLP vaccine candidate is
designed to cover the two genogroups that cause the majority of illness
in humans. It is the only clinical-stage vaccine against norovirus under
investigation at this time. Takeda has published
results of a Phase 1/2 challenge study, which showed that the candidate
vaccine is generally well-tolerated, and had a clinically relevant
impact on the symptoms and severity of norovirus illness after challenge.

About Norovirus

Norovirus causes approximately 90 percent of epidemic non-bacterial
outbreaks of acute infectious gastroenteritis around the world.
Norovirus is a common intestinal infection marked by watery diarrhea,
vomiting, abdominal cramps, nausea and sometimes fever.1,2
Notably, most cases are endemic, occurring separate from outbreaks.
According to U.S. Centers for Disease Control and Prevention (CDC)
estimates, on average, people will experience four to five episodes of
norovirus in their life10. The virus typically is transmitted
by the fecal-oral route, by aerosol or the environment, and by
person-to-person contact, either directly or through contaminated food
or water. Wherever people gather there is an increased risk. This
includes the military, travelers, students living in dormitories,
infants in child care, restaurants, hospitality and health care
environments. Norovirus gastroenteritis can have a significant impact in
all age groups, but most importantly in older adults and young children,
and may lead to severe complications including death. 4
Currently, there is no commercially available vaccine for norovirus.

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

Takeda Pharmaceutical Company Limited 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.

1 Centers for Disease Control and Prevention, Norovirus
Symptoms, Accessed June 15, 2016, from http://www.cdc.gov/norovirus/about/symptoms.html

2 Centers for Disease Control and Prevention, Norovirus
Clinical Overview. Accessed June 15, 2016, from https://www.cdc.gov/norovirus/hcp/clinical-overview.html

3 Aron J. Hall, Roger I. Glass & Umesh D. Parashar (2016):
New insights into the global burden of noroviruses and opportunities for
prevention, Expert Review of Vaccines, DOI: 10.1080/14760584.2016.1178069

4 Bartsch, S.M., Lopman, B.A., et.al. (2016). Global Economic
Burden of Norovirus Gastroenteritis. PLoS One (2016)

5 FDA, FDA Approves New Vaccine for Prevention of Cervical
Cancer, Accessed February 25, 2016, from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187048.htm

6 FDA, Highlights Of Prescribing Information, Engerix-B,
Accessed February 25, 2016, from https://laprensafl.files.wordpress.com/2016/06/ucm224503.pdf

7 EMA, Gardasil 9 offers wider protection against cancers
caused by human papillomavirus (HPV), Accessed February 25, 2016, from http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/03/news_detail_002295.jsp&mid=WC0b01ac058004d5c1

8 EMA, Engerix B, Accessed February 25, 2016, from http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Engerix_B/human_referral_000098.jsp

9 Press release issued by Merck. CORRECTING and REPLACING
Merck Receives Approval to Market GARDASIL®, ZOLINZA® and CUBICIN® in
Japan. Accessed March 2016, from http://www.businesswire.com/news/home/20110701005336/en/CORRECTING-REPLACING-Merck-Receives-Approval-Market-GARDASIL%C2%AE

10 CDC Norovirus In The United States. Accessed March 2016,
from https://laprensafl.files.wordpress.com/2016/06/eid_9-13_norovirusintheunitedstates.pdf


Takeda Pharmaceutical Company Limited
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TEL: +1 224-554-3185
Japanese media:
Tsuyoshi Tada
TEL: +81-3-3278-2417