Radiopharmaceutical Synthesis Device (MPS200Aβ) Receives Medical Device Approval

October 02, 2015

Sumitomo Heavy Industries, Ltd.
Eli Lilly Japan, K.K.

Achieves synthesis of “florbetapir(18F) Injection Solution”, a radiolabeled compound that allows for the visualization of amyloid beta plaque in the brain, one of the main reasons for Alzheimer’s disease type dementia, using a PET scan

Sumitomo Heavy Industries Limited (Head Office: Shinagawa-ku, Tokyo, Japan; President and CEO: Shunsuke Betsukawa; hereinafter referred to as “SHI” or the “Company”) and Eli Lilly Japan K.K. (Head Office: Kobe-City, Hyogo Prefecture; President and Representative Director: Patrik Jonsson; hereinafter referred to as “Eli Lilly Japan”) announced today that SHI’s radiopharmaceutical synthesis device called MPS200Aβ that produces the radiolabeled compound “florbetapir(18F) Injection Solution” received approval for medical device sales and distribution effective October 2, 2015 (Medical Device Sales and Distribution Approval No. 27700BZX00277000). This development is significant because “florbetapir(18F) Injection Solution” allows for the visualization of amyloid beta plaque present in the brains of patients with cognitive impairment who are suspected of having Alzheimer’s-disease type dementia.

One factor behind Alzheimer’s disease type dementia is said to be a protein called amyloid beta in the brain that clumps together to form amyloid beta plaque. This plaque accumulates around areas of the brain that relates to memory and activity, reducing neurons in the brain, and consequently decreasing brain function or causing atrophy, ultimately leading to cognitive impairment. “florbetapir(18F) Injection Solution” is a radiolabeled compound that is used in a PET (Positron Emission Tomography) scan to allow for the visualization of amyloid plaque in the brain. It was approved in the United States on April 6, 2012 and has been made commercially available since.

SHI holds the largest domestic share of the cyclotron market, which are used to make radioisotopes which forms the raw material for “florbetapir(18F) Injection Solution”. In addition, it has built up significant experience in the field of radiopharmaceutical synthesis devices utilized in PET scans. This radiopharmaceutical synthesis device that can be used in PET scans to detect amyloid beta plaque in the brain is the first domestically manufactured device approved for sale and distribution as a medical device. SHI plans to start selling the MPS200Aβ, along with engineering services including facility environment management that is required to manufacture “florbetapir(18F) Injection Solution”, on November 1, 2015.

Through the cooperation between SHI and Eli Lilly Japan to develop technologies relating to and distribute radiopharmaceutical synthesis devices for the production of “florbetapir(18F) Injection Solution”, the two companies aim to build on corporate efforts to contribute towards the appropriate diagnosis of Alzheimer’s disease type dementia.

*About PET (Positron Emission Tomography) scan
PET scan is a method in which an external “PET camera” is used to visualize and examine the behavior of an injected positron-emitting test drug that moves inside the body and concentrates on various places of the brain and other organs. It can be used to diagnose the brain, the heart and cancer through the use of different test drugs selected in accordance with test purposes.

** About the “florbetapir (18F) Injection Solution”
“florbetapir (18F) Injection” is a diagnostic radiopharmaceutical used in PET imaging to detect amyloid beta plaque density in the brains of patients with cognitive impairment and confirm if their impairment is caused by Alzheimer’s disease or any other causes. The “florbetapir (18F) Injection” should be used in conjunction with a clinical evaluation.

About Sumitomo Heavy Industries, Limited
Sumitomo Heavy Industries Limited is an integrated manufacturer and distributor of various industrial equipment ranging from general machinery to cutting-edge precision control equipment and components. In the field of medical equipment, SHI contributes towards the development of medical technologies through the provision of medical devices that utilizes accelerator technologies such as boron neutron capture therapy (BNCT) systems, proton radiation-based cancer therapy equipment, and pharmaceutical synthesis devices that produces injections for use in PET (positron emission tomography) scans. For further details, please visit SHI’s website at

About Eli Lilly Japan K.K.
Eli Lilly Japan K.K. is a subsidiary of Eli Lilly and Company and is celebrating the 40th anniversary of its foundation this year. It contributes to medical treatment in Japan through the development, manufacture, import and sale of innovative pharmaceutical products that allow people to live longer, healthier, and more fulfilling lives. Lilly provides therapeutic agents for schizophrenia, depression, bipolar disorder, attention deficit disorder / hyperactivity disorder (AD/HD), cancer (non-small cell lung cancer, pancreatic cancer, biliary tract cancer, malignant pleural mesothelioma, urothelial carcinoma, breast cancer, ovarian cancer, malignant lymphoma and gastric cancer), diabetes, mellitus, growth deficiencies, osteoporosis, etc. Lilly is also developing diagnostic agents and therapeutic agents for Alzheimer-type dementia, rheumatoid arthritis, psoriasis, hypercholesterolemia, and other ailments. For more details, please visit our website at