Notice Regarding a Collaboration Agreement of a Pharmaceutical Synthesizing Device for “florbetapir (18F) Injection”*, a Diagnostic Agent for Alzheimer’s Disease-Type Dementia

August 07, 2013

Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; President and CEO: Shunsuke Betsukawa; hereinafter called “SHI” or the “Company”) and Eli Lily Japan K.K. (Head Office: Kobe City, Hyogo Prefecture; President and Representative Corporate Officer: Alfonso G. Zulueta; hereinafter called “ELJ”) today announced that the two companies have signed a collaboration agreement of SHI’s pharmaceutical synthesizing device for “florbetapir (18F) Injection” with the aim to achieve domestic regulatory approval of the device. “florbetapir (18F) Injection” is a radioactive diagnostic agent for use in the test to detect Alzheimer’s disease-type dementia in patients with cognitive decline.

In Alzheimer’s disease-type dementia, a decline in cognitive function is considered to occur as a result of stagnant activity and atrophy of the brain triggered by a protein called amyloid beta which accumulates in the entire brain as amyloid beta plaques, and subsequently reduces the number of the nerve cells. The “florbetapir (18F) Injection” is a radioactive diagnostic agent used to visualize amyloid beta plaque in the brain through a Positron Emission Tomography (PET)** imaging test. First approved and launched in the United States in 2012, the diagnostic agent was also approved for use in the European Union in January of this year. In Japan, ELJ submitted an application to request approval for a pharmaceutical synthesis device for producing the diagnostic drug in May of this year***.

Under the agreement, SHI and ELJ will work together to submit an application to request approval for a pharmaceutical synthesis device, developed by SHI, that produces “florbetapir (18F) Injection”. The aim of the joint corporate effort is to contribute towards the accurate diagnosis of Alzheimer’s disease-type dementia***.

* About the “florbetapir (18F) Injection”
“florbetapir (18F) Injection” is a diagnostic radiopharmaceutical used in PET imaging to detect beta-amyloid 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 PET Imaging
PET Imaging 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.

*** Separately from this agreement, ELJ has submitted an application for the “NEPTIS plug-01”, a pharmaceutical synthesis device in May of this year.