Oxford 2 December 2015 - Blue Earth Diagnostics Ltd. (“BED”), a private diagnostics company, announced that a New Drug Application (NDA) filing for Fluciclovine has been accepted by the U.S. Food and Drug Administration (FDA) for priority review.
BED is seeking U.S. marketing approval of Fluciclovine for lesion detection and localisation for prostate cancer patients experiencing biochemical recurrence. If approved, Siemens’ PETNET Solutions, Inc., will be responsible for the manufacture, distribution and sale of the product to clinical imaging centers in the United States.
Fluciclovine (18F) is a synthetic amino acid investigational positron emission tomography (PET) radiopharmaceutical being investigated in the imaging of various cancers by BED, with its lead product being in prostate cancer. The NDA submission for Fluciclovine is based on data from more than 700 prostate cancer patients, most with biochemical recurrence and some with high risk primary disease, imaged in the United States, Norway and Italy.
Jonathan Allis, CEO of Blue Earth Diagnostics Ltd., said:
“Blue Earth Diagnostics’ mission is to transform the clinical management of cancer through the development of new molecular imaging technologies and the NDA filing of Fluciclovine marks an important step forward for the future of this imaging agent. We are pleased that the FDA has recognised the high unmet medical need in prostate cancer patients and granted the product a priority review, setting the stage for us to bring this important imaging agent to market in the quickest possible time frame.”
Barry Scott, Head of Siemens’ PETNET Solutions, Inc., commented:
“As the nation’s largest commercial manufacturer and distributor of PET radiopharmaceuticals, we are delighted to work with Blue Earth Diagnostics to provide access to imaging agents for the evaluation of cancer. We are committed to offering PET radiopharmaceuticals that yield valuable clinical information to help physicians make effective treatment decisions. We look forward to the potential approval of Fluciclovine and to supporting diagnostic imaging options for prostate cancer patients.”
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.
Blue Earth Diagnostics Ltd. was formed in March 2014 and is funded by Syncona Partners LLP. The Company licensed the PET imaging agent Fluciclovine (18F), also known as FACBC, from GE Healthcare.
