On December 5, 2019 Zionexa, a radiopharmaceutical company specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) biomarkers, reported that they have entered into an exclusive agreement for the manufacturing and distribution of Zionexa’s new PET diagnostic drug, Fluoroestradiol (FES), which is pending approval by the Food and Drug Administration (FDA) (Press release, Zionexa, DEC 5, 2019, View Source [SID1234551977]).
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Fluoroestradiol (FES) is currently only approved for use in France for the characterization of estrogen receptor status in metastatic breast cancer.
"The Zionexa team is very excited to partner with PETNET in order to produce and distribute FES in the United States and ensure patients with metastatic breast cancer have access to this major innovation," said Bernard Landes, President & CEO Zionexa, "We are proud to work with the world-class team at PETNET to get this important diagnostic biomarker into the hands of clinicians. Studies have shown a high correlation between in-vitro immunohistochemistry assessment of estrogen receptor status and imaging findings using this biomarker. This new biomarker can provide clinicians with additional information to make more informed therapeutic decisions," said Peter Webner Zionexa CEO USA.
Barry Scott, Head of PETNET Solutions, added, "We are delighted to work with Zionexa to provide access to a new PET radiopharmaceutical that yields valuable clinical information to help physicians make treatment decisions. This agreement also allows PETNET to add to our portfolio of oncologic biomarkers and truly enable healthcare providers to practice precision medicine."’