Blue Earth Diagnostics Continues to Expand Access to Axumin® (fluciclovine (18F)) with First Commercial Supply in Slovakia, Europe

OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics Ltd, a Bracco company focused on molecular imaging diagnostics, today announced expanded access to Axumin® (fluciclovine (18F)) in Europe. The first commercial delivery of Axumin was made in Slovakia in April 2020. This was possible through the Blue Earth Diagnostics’ distribution partner in Slovakia, MGP, spol. s r. o. Axumin is a PET imaging agent approved in the European Union for use in men with suspected recurrence of prostate cancer. Axumin is commercially available in Belgium, Luxembourg, Italy, France, Norway, the Czech Republic, The Netherlands, Austria and, now, Slovakia, with further European countries set to follow soon.

Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “We are very pleased that Axumin is now available in Slovakia. Expansion of supply into this new European country demonstrates the productive relationships that we have with our manufacturing and distribution partners, and supports our mission to make Axumin commercially available to clinicians and their patients across Europe.”

Karel Zeleny, Chief Executive Officer of MGP commented, “We are proud of our continuing partnership with Blue Earth Diagnostics, and are happy to be able to distribute Axumin to another new market, contributing to the management of patients with prostate cancer recurrence.”

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Formed in 2014, Blue Earth Diagnostics is led by recognized experts in the clinical development and commercialization of innovative nuclear medicine products. The company’s first approved and commercially available product is Axumin® (fluciclovine (18F)), a novel molecular imaging agent approved in the United States and European Union for use in PET imaging to detect and localize prostate cancer in men with a diagnosis of biochemical recurrence. Fluciclovine (18F) has a broad range of other potential applications in cancer imaging and Blue Earth Diagnostics is investigating the molecule for other cancers including in neuro-oncology. The company's pipeline includes innovative Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid ("rh") agents, which are a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer. Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging. For more information, visit: www.blueearthdiagnostics.com.

This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe. The approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label at www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004197/human_med_002100.jsp&mid=WC0b01ac058001d124 for complete information or contact Blue Earth Diagnostics.