Blue Earth Diagnostics Announces Presentations on Axumin® (Fluciclovine F 18), 18F-Fluciclovine and 18F-rhPSMA at Upcoming American Urological Association’s 2019 Annual Meeting

BURLINGTON, Mass. & OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced upcoming presentations at the American Urological
Association’s 2019 Annual Meeting, AUA2019, being held May 3 – 6, 2019,
in Chicago, Ill. Presentations on Axumin^® (fluciclovine F 18)
Injection include additional analyses from the LOCATE clinical trial
(NCT02680041), a prospective, U.S., multicenter, open-label study
investigating the impact of ¹⁸F fluciclovine PET/CT imaging
on patient management of biochemically recurrent prostate cancer after
initial prostate cancer treatment and negative or equivocal findings on
standard-of-care imaging.

Additional presentations include an investigational use of ¹⁸F-fluciclovine
and initial clinical experience by the Technical University of Munich
with ¹⁸F-rhPSMA-7, a Prostate Specific Membrane
Antigen-targeted radiohybrid PET imaging agent representative of the
family of rhPSMA agents that the company licensed in 2018. Details of
the presentations to be made by Blue Earth Diagnostics collaborators are
listed below.

Blue Earth Diagnostics invites participants at AUA2019 to attend the
above presentations and to learn more about the company at Booth 3040.

NOTE: Axumin^® (fluciclovine F 18) injection is FDA-approved
for positron emission tomography (PET) imaging in men with suspected
prostate cancer recurrence based on elevated blood prostate specific
antigen (PSA) levels following prior treatment. Presentations noted by
“*” discuss results of investigational studies or experiences with an
investigational agent for which the safety and efficacy have not been
established by the FDA.

U.S. Indication and Important Safety
Information About Axumin

INDICATION

Axumin^® (fluciclovine F 18) injection is indicated for
positron emission tomography (PET) imaging in men with suspected
prostate cancer recurrence based on elevated blood prostate specific
antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with Axumin PET imaging. A
  negative image does not rule out recurrent prostate cancer and a
  positive image does not confirm its presence. The performance of
  Axumin seems to be affected by PSA levels. Axumin uptake may occur
  with other cancers and benign prostatic hypertrophy in primary
  prostate cancer. Clinical correlation, which may include
  histopathological evaluation, is recommended.
• Hypersensitivity reactions, including anaphylaxis, may occur in
  patients who receive Axumin. Emergency resuscitation equipment and
  personnel should be immediately available.
• Axumin use contributes to a patient’s overall long-term cumulative
  radiation exposure, which is associated with an increased risk of
  cancer. Safe handling practices should be used to minimize radiation
  exposure to the patient and health care providers.
• Adverse reactions were reported in ≤ 1% of subjects during clinical
  studies with Axumin. The most common adverse reactions were injection
  site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1
(1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin^® (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for
use in positron emission tomography (PET) imaging to identify suspected
sites of prostate cancer recurrence in men. Recurrence of prostate
cancer is suspected by an increase in prostate specific antigen (PSA)
levels following prior treatment. PET imaging with Axumin may identify
the location and extent of such recurrence. Axumin was developed to
enable visualization of the increased amino acid transport that occurs
in many cancers, including prostate cancer. It consists of a synthetic
amino acid that is preferentially taken up by prostate cancer cells
compared with surrounding normal tissues, and is labeled with the
radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at
Emory University in Atlanta, Ga., with much of the fundamental clinical
development work carried out by physicians at Emory University’s
Department of Radiology and Imaging Sciences. Axumin was approved by the
U.S. Food and Drug Administration in May 2016, following Priority
Review, and is the first product commercialized by Blue Earth
Diagnostics, which licensed the product from GE Healthcare. The molecule
is being investigated by Blue Earth Diagnostics for other potential
cancer indications, such as glioma.

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.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan
Vice
President, Corporate Communications
(M) (781) 799-7917
[email protected]

Media
Sam Brown Inc.
Mike Beyer
(M) (312) 961-2502
[email protected]

For Blue Earth Diagnostics (UK)
Georgina Mowatt
Communications
Manager
Tel: +44 (0) 7810 355 912
[email protected]