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Siemens' PETNET Solutions receives U.S. rights to prostate PET/CT agent

by Gus Iversen, Editor in Chief | May 21, 2015
Business Affairs Molecular Imaging Rad Oncology
According to the American Cancer Society, prostate cancer is the second leading cause of cancer in men worldwide. In the U.S. alone, over 220,000 men are expected to be diagnosed this year.

An investigational positron emission tomography and computer tomography (PET/CT) radiopharmaceutical called Fluciclovine (18F) may play an important role in the future of that diagnosis.

Blue Earth Diagnostics (BED) is a private company based in the U.K., backed by Syncona Partners LLP, a subsidiary of the Wellcome Trust, that is developing and commercializing PET agents. In a just-announced agreement, it has granted manufacturing and distribution rights for Fluciclovine to Siemens' PETNET Solutions.
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Although not yet FDA approved, there are clinical trials underway in the U.S. and several other countries to further understand the medical value of the isotope. Once the FDA approval is complete, Siemens' PETNET Solutions will be the nation's exclusive distributor.

“This agreement is further proof that Siemens is at the forefront of providing solutions that address society’s most challenging diseases... Siemens’ PETNET Solutions is pleased to announce its U.S.-wide agreement with BED to distribute its Fluciclovine PET radiopharmaceutical in the United States once it gains FDA approval,” said Barry Scott, CEO of Siemens’ PETNET Solutions, in a statement.

“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., and ultimately to bring this product to patients in the U.S.,” said Jonathan Allis, CEO of BED.

Fluciclovine has a long half-life which is an important consideration in the distribution of radiopharmaceuticals, which deteriorate over time.

The announcement comes just weeks in advance of the annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), a major international event for people and organizations looking to advance the capabilities and availability of cutting edge nuclear science.

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