Blue Earth Diagnostics Announces Addition of Axumin® (fluciclovine (18F)) to EAU Guidelines for imaging in patients with biochemical recurrence in Prostate Cancer

OXFORD, England--()--Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that Axumin (fluciclovine (18F)) has recently been added to the European Association of Urology (EAU) 2019 Clinical Practice Guidelines in Oncology for Prostate Cancer (PCa). The EAU PCa Guidelines assist clinicians in making informed decisions, taking into consideration the scientific data available and individual circumstances of patients. These updated EAU PCa Guidelines state that “18F – Fluciclovine has been approved in the US and Europe, and therefore is currently the only PCa-specific radiotracer widely commercially available.”

Axumin is the first and only novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize recurrent prostate cancer. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics said “We are delighted that Axumin has been included in the EAU Guidelines as it is an important recognition of the clinical value of our product. Inclusion in these guidelines can help facilitate increased access, in concurrence with our commitment to maximize access to Axumin to patients and clinicians in Europe.”

Prostate cancer is a leading cause of cancer death in men in Europe, with around 450,000 new cases diagnosed each year1.

The European Association of Urology (EAU) is the leading authority within Europe on urological practice, research and education, with a mission to raise the level of urological care throughout Europe and beyond.

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 F 18), 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. The company’s pipeline includes Prostate Specific Membrane Antigen (PSMA)-targeted radiohybrid (“rh”) agents. rhPSMA is a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer. Blue Earth Diagnostics is backed by Syncona, an investment company listed on the London Stock Exchange (LON: SYNC). 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.

1. Ferlay J, et al. Eur J Cancer. 2018;103:356-387

https://reader.elsevier.com/reader/sd/pii/S0959804918309559?token=4632C43C716E60CDE8DA9BCB133FEB92582CFDA73CDA888CBDE61F901D17F54B851B3A06178775B1CB33F32346D411E7

Contacts

Blue Earth Diagnostics (Europe)
Georgina Mowatt
Communications Manager
Tel: +44 (0) 7810 355 912
g.mowatt@blueearthdx.com

Media inquiries:
Sam Brown Inc. (for Blue Earth Diagnostics)
Mike Beyer
Tel: +1 312-961-2502
mikebeyer@sambrown.com

Contacts

Blue Earth Diagnostics (Europe)
Georgina Mowatt
Communications Manager
Tel: +44 (0) 7810 355 912
g.mowatt@blueearthdx.com

Media inquiries:
Sam Brown Inc. (for Blue Earth Diagnostics)
Mike Beyer
Tel: +1 312-961-2502
mikebeyer@sambrown.com