AND EXCHANGE COMMISSION
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month
of October 2016
File Number: 001-36826
ACCELERATOR APPLICATIONS S.A.
(Exact name of registrant as specified
in its charter)
Saint Genis Pouilly, France
of principal executive office)
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
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 authorized.
||ADVANCED ACCELERATOR APPLICATIONS S.A.|
||/s/ Heinz Mäusli|
||Chief Financial Officer|
October 17, 2016
ACCELERATOR APPLICATIONS S.A.
||Press Release dated October 17, 2016 titled “Advanced Accelerator Applications Announces
Positive EMA Opinion on Application for SomaKit TOC”|
Advanced Accelerator Applications Announces Positive EMA Opinion on Application for SomaKit TOC
Saint-Genis-Pouilly, France – October 17, 2016 – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA”
or “the Company”), an international specialist in molecular nuclear medicine, today announced that the European Medicines
Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40 µg, a
kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography
(PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic
neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases.
Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months. Once
marketing authorization is granted, SomaKit TOC will benefit from 10-year orphan market exclusivity in the European territory.
believe our diagnostic products offer significant benefits to NET patients, including enhanced accuracy and
alleviating patient burden,” said Stefano Buono, Chief Executive Officer of AAA. “We look forward to making
SomaKit TOC available to the European market following approval by the EC.”
Neuro Endocrine Tumors (NETs)
Tumors, also known as NETs, are a group of tumors originating in the neuroendocrine cells of many different organs. NETs can remain
clinically silent for years delaying the diagnosis in a large number of patients. These cancers are rare but they are the second
most common type of gastrointestinal malignancy and their incidence is increasing. The estimated incidence of NETs for the combined
populations of the United States and the European Union is approximately 47,300. Even though NETs have historically been considered
as rare tumors (orphan disease) their incidence has grown over 500% over the last 3 decades. NETs are classified as orphan diseases
by European and U.S. regulatory authorities, meaning that they affect a relatively small population of individuals in the relevant
jurisdiction. In the United States, orphan drugs are defined as drugs that treat diseases or conditions that affect 200,000 or
fewer individuals in the country. In the European Union, orphan drugs are defined as drugs that treat diseases or conditions that
affect fewer than five out of 10,000 individuals in the European Union.
About Advanced Accelerator Applications
Accelerator Applications (AAA) is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular
Nuclear Medicine (MNM) products. AAA’s lead therapeutic product candidate, Lutathera®, is a novel MNM compound
that AAA is currently developing for the treatment of Neuro Endocrine Tumors, a significant unmet medical need.
Founded in 2002,
AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture
both diagnostics and therapeutic MNM products, and has over 450 employees in 13 countries (France, Italy, UK, Germany, Switzerland,
Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015
(+26.8% vs. 2014) and sales of €54.6 million for 1H 2016 (+26.9% vs. 1H15). AAA is listed on the Nasdaq Global Select Market
under the ticker “AAAP”. For more information, please visit: www.adacap.com.
Molecular Nuclear Medicine (“MNM”)
Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images
of organs and lesions and to treat various diseases, such as cancer. The technique works by injecting targeted radiopharmaceuticals
into the patient’s body that accumulate in the organs or lesions and reveal specific biochemical processes. Molecular Nuclear
Diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single
Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer,
cardiovascular diseases, neurological disorders and other diseases in their early stages.
Statement Regarding Forward-Looking Statements
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 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 Lutathera® and our
other products or product candidates; our estimates regarding the market opportunity for 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 U.S.; 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; and general
economic, political, demographic and business conditions in Europe, the U.S. 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
Axess Public Relations (Italy)
Tel: +39 3488818029