Cardinal Health to Prepare NETSPOT™ Doses for Advanced Accelerator Applications

SAINT-GENIS-POUILLY, France, June 09, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that it has selected Cardinal Health, Inc. (NYSE:CAH), a healthcare services company operating the largest radiopharmaceutical network in the United States, to supply gallium 68 (Ga 68) dotatate doses prepared with a novel kit to U.S. hospitals and imaging centers.

NETSPOTTM (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“).

Cardinal Health’s extensive U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver NETSPOTTM patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated. This partnership makes Cardinal Health the second radiopharmacy network that will participate in the NETSPOTTM supply chain, after the announcement of the Zevacor Pharma partnership earlier this year.

We believe that NETSPOTTM has the potential to improve the accuracy of diagnosis while reducing radiation exposure for patients compared to the existing standard,” said Stefano Buono, Chief Executive Officer of AAA. “We are pleased to have signed this non-exclusive agreement with Cardinal Health for the preparation and delivery of NETSPOTTM. We believe that Cardinal Health’s extensive footprint, and deep expertise in preparation of kit based products, will make it an excellent partner in creating broad availability of this innovative product. We believe the establishment of broadly available doses of Ga 68 radiopharmaceuticals will also mark an important milestone in the development of PET imaging, a development similar to the establishment of unit dose supply of Fluorine-18 labeled radiopharmaceuticals in the early 2000’s.”


NETSPOTTM is a novel patented kit developed by AAA for the preparation of gallium Ga 68 dotatate for injection, for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients using Positron Emission Tomography (“PET“). The kit has been designated as an orphan drug by the EMA and the FDA. For full prescribing information for NETSPOTTM please refer to: http://go.usa.gov/cSywA.

About Advanced Accelerator Applications

Advanced 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 20 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 440 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 €26.9 million for 1Q 2016 (+29.6% vs. 1Q15). 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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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 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.

Contacts: AAA Media Relations Véronique Mermet Communications Officer info@adacap.com Tel: +33 (0)4 50 99 30 70 AAA Investor Relations Jordan Silverstein Director of Investor Relations jordan.silverstein@adacap.com Tel: + 1-212-235-2394 Media inquiries FTI Consulting Shauna Elkin shauna.elkin@fticonsulting.com Tel: +1-212-850-5613 Axess Public Relations (Italy) Dario Francolino dario.francolino@axesspr.com Tel: +39 3488818029

Source: Advanced Accelerator Applications