Takeda Initiates World's First Norovirus Vaccine Field Trial

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

Osaka, Japan, June 20, 2016 – Takeda Pharmaceutical Company Limited [TSE: 4502], (“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 countries.⁴

“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 Agency^7,8 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 globe.”

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 life.¹⁰ 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.

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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 http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/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 http://www2c.cdc.gov/podcasts/media/pdf/EID_9-13_NorovirusInTheUnitedStates.pdf