PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA Inc., has signed an agreement with UK-based Blue Earth Diagnostics Ltd. for the exclusive US commercial manufacturing and distribution of Fluciclovine (18F).
The investigational positron emission tomography and computed tomography (PET/CT) radiopharmaceutical is being studied for prostate imaging in clinical trials conducted in the United States, Japan, Italy, Norway, Sweden, and Finland. The imaging agent has a long half-life, which may facilitate its geographical distribution to clinical trial sites and then to clinical imaging centers upon approval from the Food and Drug Administration (FDA).
Prostate cancer is the second-leading cause of cancer in men worldwide, with 220,800 men expected to be diagnosed in 2015 in the United States alone.¹ At this time, approved diagnostic options for prostate cancer include PET/CT scans using an injectable radiopharmaceutical to evaluate the extent of metastatic disease specifically for soft tissues and bony anatomy.
With its large domestic commercial radiopharmacy network, Siemens’ PETNET Solutions offers wide access to PET radiopharmaceuticals for oncology, cardiology, and neurology to imaging physicians and patients. Blue Earth Diagnostics Ltd. is a private diagnostics company backed by Syncona Partners LLP, a subsidiary of the Wellcome Trust that is developing and commercializing PET agents for cancer.
“Siemens’ PETNET Solutions is pleased to announce its US-wide agreement with Blue Earth Diagnostics Ltd. to distribute its Fluciclovine (18F) PET radiopharmaceutical in the United States once it gains FDA approval,” said Barry Scott, chief executive of Siemens’ PETNET Solutions. “This agreement is further proof that Siemens is at the forefront of providing solutions that address society’s most challenging diseases. Our continued investment in our network enables us to offer physicians greater access to PET radiopharmaceuticals, which yield valuable clinical information to support proper treatment decisions.”
“We are pleased that more than 1,000 subjects have now been imaged with Fluciclovine (18F), ” said Jonathan Allis, CEO of Blue Earth Diagnostics Ltd. “Working with Siemens’ PETNET Solutions, we look forward to setting up the infrastructure to prepare for regulatory filing in the USA, and ultimately to bring this product to patients in the USA.”
For more information, visit PETNET Solutions.