Transaction expands global supply chain in preparation for the
commercial launch of Lutathera
7 January 2016, Saint-Genis-Pouilly, France – Advanced Accelerator Applications S.A. (“AAA” or
“the Company”) (Nasdaq: AAAP), an international specialist in Molecular Nuclear Medicine (“MNM”),
announced today that it has acquired 100% of the shares of the IDB Group. The IDB Group includes
IDB Holland bv, IDB Radiopharmacy bv and Beheermaatschappij Weelde bv and is a leading
manufacturer of Lutetium 177 (Lu-177). IDB produces, markets and sells Lu-177 under the brand
name LuMark®, and has established this product as the leading brand of Lutetium 177 worldwide.
LuMark® is the only Lu-177 product to have received European Marketing Authorization.
Acquiring the IDB Group will enable AAA to own one of its two providers of Lu-177 for Lutathera and
build its own Lu-177 manufacturing business. This acquisition strengthens AAA’s leadership position
in European MNM and is in-line with the Company’s vertical integration strategy. Owning the IDB
Group will help AAA maintain a reliable supply of Lu-177 for the production of Lutathera and AAA’s
future product candidates.
Stefano Buono, Chief Executive Officer of AAA commented: “We believe that our key product
candidate Lutathera (177Lu-DOTATATE) has the potential to dramatically shift the treatment
paradigm for patients with progressive neuroendocrine tumors and improve the standard of care for
this disease. With this shift in treatment, Lu-177 chloride has a significant opportunity to be
recognized as an important radiopharmaceutical precursor.”
Lu-177 is an emitter of high-energy beta particles (particles used for many years in radiation
oncology to treat solid cancers) that can be effectively used to deliver toxic effects to metastatic
cancers, using a targeted radiopharmaceutical approach similar to Lutathera. A small gamma
emission ensures the possibility to visualize and measure the quantity of drug that is delivered both
to the target lesions and to the rest of the body to facilitate the safe use of this class of drugs.
“We intend to use Lu-177 chloride extensively in the development of other product candidates for
other indications. This acquisition uniquely positions AAA with the ability to independently produce
this critical radionuclide for our own use, while possibly creating new avenues of development for our
expansion into a unique and uncovered territory for our existing and forthcoming portfolio products,”
The IDB Group is located in Baarle-Nassau, The Netherlands. It is an international franchise in
isotope manufacturing and sale. In 2014 the IDB Group net sales represented approximately 7
million Euros. The IDB Group’s key assets include a business with historically increasing revenue,
and an experienced leadership team with a lean and efficient management structure. Products
distributed by IDB include a Ge-68/Ga-68 generator, which is used in state-of-the-art PET peptide
imaging such as Somakit.
Gérard Ber, Chief Operating Officer of AAA added: “Acquiring the IDB Group enables AAA to gain
the potential to expand the Company’s presence to the Netherlands for both our current portfolio of
F-18 products as well as our product candidates Somakit and Lutathera. AAA will continue to serve
IDB clients around the world and further expand and improve our services. This acquisition provides
AAA with a key strategic asset allowing the Company to build an independent Lu-177 manufacturing
business, while helping to expand the current presence of its F-18 portfolio, Lutathera, and Somakit,
in the Netherlands.”
About Lutathera and Somakit
Lutathera (or 177Lu-DOTATATE) is a Lu-177-labeled somatostatin analogue peptide currently under
development for the treatment of GastroEntero Pancreatic Neuroendocrine Tumors (GEP-NETs).
This novel compound has received Orphan Drug Designation from the European Medicines Agency
(EMA) and the US Food and Drug Administration (FDA). Lutathera was also granted fast-track
designation by the FDA in April 2015 for the treatment of inoperable progressive midgut NETs. The
FDA provides fast-track designation to product candidates that treat serious conditions and fill an
unmet medical need in order to facilitate their development and expedite their review. Lutathera is
also currently administered on a compassionate use and named patient basis for the treatment of
NETs in ten European countries.
Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy
(“PRRT“), which involves targeting carcinoid tumors with radiolabeled somatostatin analogue
peptides. Currently at the end of its Phase 3 development in its pivotal NETTER-1 study, Lutathera is
the most advanced candidate in development for PRRT.
The Phase 3 NETTER-1 study evaluating Lutathera in patients with advanced midgut
neuroendocrine tumors met its primary endpoint by demonstrating that treatment with Lutathera was
associated with a statistically significant and clinically meaningful risk reduction of 79% in disease
progression or death versus a treatment with a double dose of Octreotide LAR (hazard ratio 0.21,
95% CI: 0.13-0.34; p<0.0001). The results were presented on 27 September 2015 at the European
Cancer Congress in Vienna during Presidential Session II.
Lutathera’s companion PET diagnostic Somakit is a patented Kit for the preparation of 68Ga-
DOTATATE for injection, which is in development to help diagnose and manage somatostatin
receptor-positive NET patients using Positron Emission Tomography (“PET“). We believe that
Somakit has the potential to significantly improve the accuracy of diagnosis while reducing radiation
exposure for patients.
About Neuro Endocrine Tumors (NETs)
Neuro Endocrine 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, for example, 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 was approximately 47,300 in 2013.
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
Advanced 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 390 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
About Molecular Nuclear Medicine (“MNM”)
Molecular 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.
Cautionary Statement Regarding Forward-Looking Statements
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 forwardlooking
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 forwardlooking
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 9134595