SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2017
Commission File Number: 001-36826
ADVANCED ACCELERATOR APPLICATIONS S.A.
(Exact name of registrant as specified
in its charter)
20 rue Diesel
01630 Saint Genis Pouilly, France
(Address of principal executive office)
Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F:
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant
is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
||ADVANCED ACCELERATOR APPLICATIONS S.A.|
||/s/ Heinz Mäusli|
||Chief Financial Officer|
Date: May 30, 2017
ADVANCED ACCELERATOR APPLICATIONS S.A.
||Press Release dated May 30, 2017 titled “Advanced Accelerator Applications and Blue Earth Diagnostics Announce European Manufacturing and Distribution Agreements for Axumin™ (Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer”|
Accelerator Applications and Blue Earth Diagnostics Announce European Manufacturing and Distribution Agreements for Axumin™
(Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer
Saint-Genis-Pouilly, France and Oxford,
UK – May 30, 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
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.”
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
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.
Cautionary Statement Regarding Forward-Looking
Statements for AAA
This press release may contain forward-looking
statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding
the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives
of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "target," "potential,"
"will," "would," "could," "should," "continue," and similar expressions are intended
to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking
statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and
uncertainties that may cause actual results, events or developments to be materially different from any future results, events
or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing
market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory
approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse
events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary
supplies and raw materials for lutetium Lu 177 dotatate (Lutathera®) and other chemical compounds acceptable for
use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product
candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the
rate and degree of market acceptance and the clinical utility of lutetium Lu 177 dotatate (Lutathera®) and our other
products or product candidates; our estimates regarding the market opportunity for lutetium Lu 177 dotatate (Lutathera®),
our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our
products; our ability to implement our growth strategy including expansion in the US; our ability to sustain and create additional
sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in
countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory
actions or litigation; and general economic, political, demographic
and business conditions in Europe, the US
and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
AAA Corporate Communications
Director of Communications
Tel: + 1-212-235-2395
AAA Investor Relations
Director of Investor Relations
Tel: + 1-212-235-2394
Blue Earth Diagnostics (US)
Vice President, Corporate Communications
Tel: + 781-799-7917
Blue Earth Diagnostics (Europe)
Dr. Val Jones
Val Jones PR Ltd
Tel: +44 (0) 7917 175 192
Makovsky & Company (for AAA)
Sam Brown Inc. (for Blue Earth Diagnostics)
Tel: + 312-961-2502
ABBREVIATED PRESCRIBING INFORMATION FOR AXUMIN IN EUROPE
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.
Date of Preparation: May 2017