Oxford 21 May 2015 - Blue Earth Diagnostics Ltd (“BED”), a private diagnostics company, has entered into an exclusive agreement with Siemens’ PETNET Solutions for the U.S. manufacture and distribution of anti-1-amino-3-F-18-fluorocyclobutane-1-carboxylic acid (F-18 FACBC) or, fluciclovine (18F), an investigational positron emission tomography (PET) radiopharmaceutical.
Fluciclovine (18F) is being investigated for the imaging of various cancers in the U.S., Japan, Italy, Norway, Sweden and Finland. Siemens’ PETNET Solutions will facilitate the geographical distribution of the F-18 based radiopharmaceutical, with a 110 minute half-life, to clinical trial sites in the USA and then to clinical imaging centers, once the product gains Food & Drug Administration (FDA) approval.
The majority of patients included in clinical studies to date were men with biochemically recurrent prostate cancer. Prostate cancer is the second leading cause of cancer in men worldwide. Approximately one third of prostate cancer patients receiving radical first line treatment will subsequently experience recurring disease not detectable on conventional imaging, but accompanied by rising prostate specific antigen (“PSA”) levels, which is known as biochemical recurrence.
Jonathan Allis, CEO of Blue Earth Diagnostics said:
“This U.S. distribution deal is the first we have signed, and with its large commercial radiopharmacy network in the USA, Siemens’ PETNET Solutions is an ideal partner to facilitate fluciclovine’s geographical distribution to U.S. clinical trial sites conducting clinical trials and then hopefully to clinical imaging centers after FDA approval. Approximately 1000 patients have been imaged to date, including comparisons to agents already in use in imaging of biochemically recurrent prostate cancer, and we expect it will yield valuable clinical information with the potential to provide clinical benefit to prostate cancer patients.”
Barry Scott, CEO of Siemens’ PETNET Solutions commented
Siemens’ PETNET Solutions is at the forefront of providing leading PET imaging solutions to fight against society’s most challenging diseases. Blue Earth Diagnostics are at the cutting edge of developing PET imaging solutions for prostate cancer and we are committed to giving physicians greater access to PET radiopharmaceuticals which yield valuable clinical information to support proper treatment decisions.”
Blue Earth Diagnostics Ltd. was formed in March 2014 with a £12.8 million investment from Syncona Partners LLP, a subsidiary of the Wellcome Trust. The Company licensed the PET imaging agent fluciclovine (18F), also known as FACBC, from GE Healthcare.
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