· Agreement with Blue Earth Diagnostics Ltd. grants U.S. rights for clinical trial supply and for exclusive commercial manufacturing and distribution of PET imaging agent upon FDA approval
Siemens’ PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA Inc., has entered into a nationwide agreement with U.K.-based Blue Earth Diagnostics Ltd. for the exclusive commercial manufacturing and distribution of Fluciclovine (18F), an investigational positron emission tomography and computed tomography (PET/CT) radiopharmaceutical. Fluciclovine (18F) is being studied for prostate imaging in clinical trials conducted in the U.S., Japan, Italy, Norway, Sweden, and Finland. The F-18-based radiopharmaceutical has a long half-life, which may facilitate its geographical distribution to clinical trial sites and then to clinical imaging centers once it gains 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 U.S. alone.1 Currently, 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/or bony anatomy.
With its large commercial radiopharmacy network in the U.S., Siemens’ PETNET Solutions provides wide access to PET radiopharmaceuticals for oncology, cardiology and neurology to imaging physicians and patients. Blue Earth Diagnostics Ltd. is a private U.K.-based diagnostic 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 U.S.-wide agreement with Blue Earth Diagnostics Ltd. to distribute its Fluciclovine (18F) PET radiopharmaceutical in the United States once it gains FDA approval,” says Barry Scott, CEO 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). Working with Siemens’ PETNET Solutions, we look forward to setting up the infrastructure to prepare for regulatory filing in the U.S.A., and ultimately to bring this product to patients in the U.S.A.,” says Jonathan Allis, CEO of Blue Earth Diagnostics Ltd.
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Siemens AG Healthcare
Phone: 610-448-1477; E-mail: jeffrey.t.bell@siemens.com
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2014, which ended on September 30, 2014, Siemens generated revenue from continuing operations of €71.9 billion and net income of €5.5 billion. At the end of September 2014, the company had around 357,000 employees worldwide. Further information is available on the Internet at www.siemens.com.
About Blue Earth Diagnostics Ltd.
BED is a private, UK-based diagnostics company focused on the development and commercialization of PET agents. The BED team is made up of industry experts in the field of imaging, chemistry, clinical development, regulatory affairs and commercialization of nuclear medicine products. The company’s lead investor, Syncona LLP, an independent subsidiary of the Wellcome Trust, is an evergreen investment company, taking an active role in identifying, supporting and developing technologies with the potential to significantly impact the healthcare market of the future. For further information, please visit www.blueearthdiagnostics.com.
