PRESS RELEASE

Blue Earth Diagnostics and Seibersdorf Laboratories Announce Manufacturing and Distribution Agreements for Axumin® (fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer

Oxford, UK – [date] 2017 – Blue Earth Diagnostics, a molecular imaging diagnostics company, and Seibersdorf Laboratories, a leading developer and manufacturer of radiopharmaceuticals, today announced that they have entered into an exclusive distribution agreement and a non-exclusive manufacturing agreement for the supply of Blue Earth Diagnostics’ Positron Emission Tomography (PET) imaging product Axumin® (fluciclovine (18F)) in certain European countries.  Under the terms of the agreements, Seibersdorf Laboratories will become the exclusive distributor of Axumin in Austria, and will manufacture for the supply of Axumin to Austria, Czech Republic, Croatia, Germany, Hungary, Slovakia and Slovenia.  Axumin is indicated in Europe for use in PET imaging to detect recurrence of prostate cancer in adult men with a 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. Following receipt of marketing authorization for Axumin from the European Commission on May 22, 2017, Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe.

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “We’re delighted to announce these agreements, which mark another significant step towards our goal of making Axumin commercially available right across Europe.  Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to maximizing access to Axumin for clinicians and their patients.  The central European location of Seibersdorf will enable us to serve imaging centres and hospitals in seven additional countries, bringing the potential benefits of Axumin to clinicians and their patients over a greatly increased geographical area.  We look forward to working with the team at Seibersdorf.”

Dr Martina Schwaiger, General Manager of Seibersdorf Laboratories said, “We are very proud that our team will be a partner in the European network for production and distribution of Axumin, which is a valuable contribution to the healthcare. Our cooperation with Blue Earth is a future-oriented project and we are looking forward with confidence to develop an excellent partnership.”


About Blue Earth Diagnostics
Blue Earth Diagnostics is a 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 the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. The Company is backed by Syncona Limited, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdiagnostics.com.

About Seibersdorf Laboratories
Seibersdorf Labor GmbH is spezialized in high quality laboratory and analysis work, application-oriented research and development as well as consulting and training.
The teams of Seibersdorf Laboratories are service, know-how and technology provider and cover a broad area of scientific expertise: development, production and quality control of radiopharmaceuticals, anti-doping and forensic analysis, radiation protection, ionizing and non-ionizing radiation, radio frequency engineering and electromagnetic compatibility.
The experts of Seibersdorf Laboratories represent Austria on various international committees.
For more information, visit: www.seibersdorf-laboratories.at



*This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe.  Please be aware that the approval status and product label for Axumin varies by country worldwide.  Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.

Contacts:

Blue Earth Diagnostics (Europe)
Dr. Val Jones
Val Jones PR Ltd
Tel: +44 (0) 7917 175 192
v.jones(at)blueearthdx.com 

Blue Earth Diagnostics (USA)
Priscilla Harlan
Vice President, Corporate Communications
Tel: +1 781-799-7917
p.harlan(at)blueearthdx.com

Seibersdorf Laboratories
Gerd-Peter Mitterecker
Communications
Tel: +43 50 550 2500
gerd-peter.mitterecker(at)seibersdorf-laboratories.at 

 

ABBREVIATED PRESCRIBING INFORMATION FOR AXUMIN IN EUROPE

▼Axumin 1600 MBq/ml solution for injection/ Axumin 3200 MBq/ml solution for injection (fluciclovine, (18F))

Indication: Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.

Dosage:  370 MBq fluciclovine (18F)

Method of use: Diagnostic use only.  I.V. administration. Refer to SmPC for dilution instructions prior to dosing and information on image acquisition.

Contraindications: Patients with hypersensitivity to active substance or excipients.

Common Adverse Reactions (reported in ≥ 1/100 to < 1/10 patients):  Injection site reactions, dysgeusia and parosmia.

Special Warnings and Precautions:  Individual benefit/risk justification: Radiation exposure of patient must be justifiable by likely benefit.  Consider possible increased radiation exposure risk in patients with renal impairment.  PSA value may affect the diagnostic performance.

Patient preparation:  Patients should avoid exercise for at least a day before and not eat or drink for at least 4 hours prior to administration.  Afterwards, encourage patients to drink water and void as often as possible during first hours to reduce radiation exposure of the bladder. Restrict close contact with infants and pregnant women for 12 hours after administration.

Interpretation of fluciclovine (18F) images and limitations of use:  Images should be interpreted visually by appropriately trained personnel.  Suspicion of cancer is based on fluciclovine (18F) uptake in comparison with tissue background. For small lesions (<1 cm diameter) focal uptake greater than blood pool should be considered suspicious for cancer. For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for cancer. Image interpretation errors can occur; fluciclovine (18F) uptake is not specific for prostate cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia. False-positive cases have been described with inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy. Clinical correlation, which may include histopathological evaluation, should be considered where appropriate.  Iodinated CT contrast or oral contrast media is not required to interpret images.  Detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.

Specific warnings: Contains up to 39 mg sodium per dose; to be taken into consideration by patients on a controlled sodium diet.  Not indicated for use in women or children.

MA Number: EU/1/17/1186/001-002

MA Holder: Blue Earth Diagnostics Ltd, 215 Euston Road, London, NW1 2BE UK.

POM

Date of Preparation: May 2017


>> Blue Earth Diagnostics