Blue Earth Diagnostics Ltd. announced a new distribution partnership for fluciclovine (18F) with Norsk medisinsk syklotronsenter AS
30.3.2016 12:04 | Norsk medisinsk syklotronsenter
Blue Earth Diagnostics Ltd. (“BED”), a private diagnostics company, announced that it agreed a new distribution partnership for fluciclovine (18F) with Norsk medisinsk syklotronsenter AS (“NMS”) to cover the Norwegian territory.
BED has submitted an application to the European Medicines Agency (EMA) for an EU/EEA marketing authorisation for fluciclovine (18F) for lesion detection and localisation for prostate cancer patients experiencing biochemical recurrence. If granted, NMS, will be responsible for the manufacture, distribution and sale of the product to clinical imaging centers in Norway.
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.
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. It is an exciting time in the Company’s development with this Norwegian distribution partnership with NMS coming soon after the U.S. Food and Drug Administration (FDA) acceptance of our New Drug Application (NDA) filing for Fluciclovine (18F). The EU/EEA markets are large and attractive markets for us and this collaboration with NMS in Norway is the first step in setting up the distribution network in these important territories.”
Thor Audun Saga, CEO of NMS, commented:
“NMS is committed to expanding the range of PET products available to patients in Norway. We look forward to developing a strong partnership with BED and supporting them in the development and distribution of new PET tracers.”
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 LLP. The Company licensed the PET imaging agent Fluciclovine (18F), also known as FACBC, from GE Healthcare.
Blue Earth Diagnostics
+44 (0) 20 7611 5734
JW Communications Julia Wilson
+44 (0) 781 8430877
Om Norsk medisinsk syklotronsenter
Postboks 4950 Nydalen
Norsk medisinsk syklotronsenter AS produserer radiofarmaka for Positron emisjonstomografi (PET) til klinisk og forskningsrettet bruk, samt driver utleie av PET/CT scannere til helseforetakene.
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