Tokyo, June 23, 2016 - the Institute of Medical Science, the University of Tokyoand Astellas Pharma Inc. today announced that they have signed a new collaborative development agreement on the rice-based oral vaccine “MucoRice-CTB” (“MucoRice”) against cholera and enterotoxigenic Escherichia coli (E coli) caused diarrheal diseases.

MucoRice is a rice-based oral vaccine expressing cholera toxin B subunit (CTB) in the intrinsic storage protein of rice using genetic engineering, which was developed by Prof. Hiroshi Kiyono, Project researcher Yoshikazu Yuki and their colleagues at International Research Development Center for Mucosal Vaccines (IMSUT).

In developing countries, diarrhea caused by pathogenic bacteria such as Vibrio cholerae and enterotoxigenic E coli, is one of the major causes of death among infants. At present, the challenges of the cholera vaccines used in developing countries are the need for the cold chain and the ineffectiveness against enterotoxigenic E coli. MucoRice is stable at room temperature and easily produced, therefore it is expected to meet the unmet medical needs of existing cholera vaccines. Under the MEXT (Ministry of Education, Culture, Sports, Science and Technology) and the AMED (Japan Agency for Medical Research and Development) Translational Research Network Program, an investigator-initiated phase 1 trial of this vaccine is nearing completion at IMSUT hospital (Principal investigator, Assoc. Prof. Osamu Hosono) in Japan. Data from this trial is now being analyzed.

Under the contract, IMSUT provides clinical trial materials and trial data, etc. which are necessary for the phase 1 and phase 2 trials of MucoRice for cholera and enterotoxigenic E coli., and Astellas is responsible for conducting and managing the clinical trials.

Through the collaborative development, IMSUT and Astellas will develop vaccines against infectious diseases affecting developing countries and hope we can address Access to Health issues.

About the Institute of Medical Science, the University of Tokyo

The Institute of Medical science, the University of Tokyo (IMSUT) was founded by Prof. Shibasaburo Kitasato in 1892 as “The Institute of Infectious Disease”. IMSUT with its own affiliated hospital is Japan's foremost university-associated research institute for medical and life science. Focusing on infectious disease, cancer and immunological diseases, our mission is to translate basic research findings directly to novel medical therapies. Thus, research environment of IMSUT is represented by the "bed to bench and bench to bed" inheriting the Kitasato’s DNA of “Wisdom and Practice” for medical science leading to the next generation of Genome-based medicine, Antibody-drugs, .Mucosal Vaccines, Gene-therapy and Regenerative medicine.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.