Advanced Accelerator Applications and Blue Earth Diagnostics Announce European Manufacturing and Distribution Agreements for Axumin™ (Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer

Published 30 May 2017

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA), an international specialist in Molecular Nuclear Medicine, and Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, today announced that they have entered into a non-exclusive manufacturing agreement and an exclusive distribution agreement for the supply of Blue Earth Diagnostics’ PET imaging product Axumin™ (fluciclovine (18F)) in France, Germany, Spain, Italy, and Portugal.

Axumin is indicated in Europe for use in 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.*

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.

Stefano Buono, Chief Executive Officer of AAA stated, “These agreements with Blue Earth Diagnostics reinforce our position as a leading partner in the highly specialized PET manufacturing and distribution market. With our broad network of 15 PET production sites in five countries, we are one of only two companies with both the specialist manufacturing skills and capacity for large-scale PET production in Europe. We look forward to working with Blue Earth Diagnostics and to further expanding our portfolio of PET products.”

Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “With its broad network, deep sector expertise and shared commitment to delivering innovative molecular imaging agents for patients and their physicians, AAA is an ideal partner for us. The agreements mark a significant step forward in making Axumin commercially available across Europe, and we look forward to working with the team at AAA.”

*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.

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 funded by Syncona Limited, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdiagnostics.com.

About Advanced Accelerator Applications S.A.

Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, lutetium Lu 177 dotatate (Lutathera®), is a novel MNM compound in development for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 21 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and more than 500 employees in 13 countries (France, Italy, the UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the US and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com.

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Contacts

AAA Corporate Communications
Rachel Levine
Director of Communications
Tel: + 1-212-235-2395
rachel.levine@adacap.com

AAA Investor Relations
Jordan Silverstein
Director of Investor Relations
Tel: + 1-212-235-2394
jordan.silverstein@adacap.com

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

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

Media inquiries

Makovsky & Company (for AAA)
Lee Davies
Tel: +212-508-9651
ldavies@makovsky.com

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

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 paraosmia.
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

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