First production and administration of Axumin® (fluciclovine (18F)) in Italy.

OXFORD, England–(BUSINESS WIRE)–Blue
Earth Diagnostics
, a leading molecular imaging diagnostics company,
today announced that the first commercial production of Axumin®
(fluciclovine (18F)) in Italy occurred recently, with the
first Italian patients being dosed. Axumin is a novel molecular imaging
agent approved in the European Union for use in PET imaging to detect
and localize prostate cancer in men experiencing suspected recurrence
based on elevated blood prostate specific antigen (PSA) levels after
primary curative treatment. Axumin is the first and only PET imaging
agent approved by the European Commission for use in men with suspected
recurrent prostate cancer in all European Union member states as well as
in Iceland, Liechtenstein and Norway. 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.

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, “Detection and localization of recurrent prostate cancer is a
significant unmet medical need, and Blue Earth is committed to
maximizing access to Axumin to clinicians and their patients across
Europe. Today’s announcement is key milestone towards our goal.”

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
.

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