AND EXCHANGE COMMISSION
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
the month of January, 2016
File Number: 001-36826
ACCELERATOR APPLICATIONS S.A.
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.|
||Chief Financial Officer|
Date: January 11, 2016
ACCELERATOR APPLICATIONS S.A.
Release dated January 11, 2016 titled “Advanced Accelerator Applications Signs Exclusive License Agreement With
Johns Hopkins University to Develop PSMA Receptor Ligand in Prostate Cancer”
Advanced Accelerator Applications Signs
Exclusive License Agreement With Johns Hopkins University to Develop PSMA Receptor Ligand in Prostate Cancer
Company broadens pipeline with PSMA-SR6,
which could be used to treat, image, monitor and stage prostate cancer utilizing a clinical
development strategy similar to Lutathera and Somakit
2016, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the
Company”), an international specialist in molecular nuclear medicine, today announced an exclusive license agreement with
Johns Hopkins University in Baltimore, Maryland to develop and market PSMA-SR6, a receptor ligand of Prostate-Specific Membrane
Antigen (PSMA) for clinical therapeutic and diagnostic purposes. AAA will focus on developing this treatment and its companion
diagnostic for prostate cancer through novel molecular nuclear medicine techniques similar to those implemented for the development
of Lutathera and Somakit. Prostate cancer affects nearly 1 in 7 men during their lifetime worldwide.
of the agreement include payment to Johns Hopkins of an upfront licensing fee, as well as certain
milestone and royalty payments.
licensing agreement is the first step toward broadening our development pipeline by leveraging a formula that we have already
successfully applied to develop our lead therapeutic and diagnostic candidates Lutathera and Somakit. We plan to radiolabel PSMA-SR6,
to develop a 177Lu-PSMA-SR6 to treat and monitor prostate cancer and a 68Ga-PSMA-SR6, which will help to
diagnose and stage disease. The PSMA expression pathway has been widely investigated with labelled antibodies, but we believe
that a small molecule, with very high specificity and rapid uptake into tumors and clearance from non-targeted organs could be
the ideal candidate for a full theragnostic approach. We are very pleased to partner with the Johns Hopkins University as they
have been pioneering and leading this new field for many years,” says Stefano Buono, Chief Executive Officer of AAA.
license agreement with AAA extends Johns Hopkins University’s research leadership in PSMA to benefit patients,”
says Neil Veloso, Executive Director of Johns Hopkins Technology Ventures. "We are very pleased that AAA has selected
PSMA-SR6 for full development for commercial applications in an area of significant patient need."
AAA is planning
to support a proof-of-concept study in humans that may start in 2016 for both diagnostic and therapeutic applications of PSMA-SR6.
is a unique second-generation selective prostate cancer PSMA receptor ligand developed by Dr Martin Pomper at Johns Hopkins University.
PSMA-SR6 has a unique structure and is selective for PSMA expressed on prostate cancer tumor cells. It belongs to a new class
of PSMA receptor ligands with high potential as diagnostic and therapeutic markers for prostate cancer. Studies have consistently
demonstrated PSMA expression in all types of prostate tissue and an increased PSMA expression in cancer tissue.
Advanced Accelerator Applications
Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 that develops innovative diagnostic and therapeutic
products. AAA’s main focus is in the field of molecular imaging and targeted, individualized therapy for patients with serious
conditions (“Personalized Medicine”). AAA currently has 17 production and R&D facilities able to manufacture both
diagnostics and therapeutic MNM products, and has over 400 employees in 11 countries (France, Italy, UK, Germany, Switzerland,
Spain, Poland, Portugal, Israel, U.S. and Canada). In 2014, AAA reported sales of €69.9 million (+29.9% vs. 2013). 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.
About Johns Hopkins Technology
Johns Hopkins Technology Ventures (JHTV) serves Johns Hopkins researchers and inventors as
a licensing, patent and technology commercialization office and acts as an active liaison to parties interested in leveraging
university research or materials for academic or corporate endeavors. JHTV helps develop new discoveries and inventions into products
and services that benefit society and transform the world. In 2014, JHTV secured more than $16 million in licensing revenue, possessed
more than 2,000 active issued patents and created 13 new startup companies. For more information about Johns Hopkins Technology
Ventures, opportunities to collaborate, start a technology venture or license a technology, visit http://ventures.jhu.edu/
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 Media Relations
Head of Corporate Communications
Tel: +33 (0)6 86 65 73 52
Tel: +33 (0)4 50 99 30 70
AAA Investor Relations
Director of Investor Relations
Tel: + 1-212-235-2394
Tel: +39 02 4678754 - +39 366