Advanced Accelerator Applications Receives 2017 Industry Innovation Award from National Organization for Rare Disorders for NETSPOT®, a Diagnostic Drug for Neuroendocrine Tumors

SAINT-GENIS-POUILLY, France, May 18, 2017 (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 will receive a 2017 Industry Innovation Award from the National Organization for Rare Disorders (NORD®) for NETSPOT® (gallium Ga 68 dotatate), a diagnostic drug for the localization of neuroendocrine tumors (NETs) using a positron emission tomography (PET) scan, at the NORD Rare Impact Awards ceremony taking place in Washington, D.C. this evening. NORD is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them. Each year, NORD’s Rare Impact Awards program recognizes individuals and organizations that have made a positive impact on patients’ lives.

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 many patients. Symptomatology may also vary widely, further complicating accurate diagnosis of NETs. These cancers are rare, but due to their indolent nature and the generally long life expectancy of NET patients, they are the second most common type of gastrointestinal malignancy in the US, and their incidence is increasing.1,2

NETSPOT®, a first-in-class drug, was approved by the US Food and Drug Administration (FDA) in June 2016, 23 months after the pre-Investigational New Drug meeting with the Agency. NETSPOT® has been designated as an orphan drug by the FDA and European Medicines Agency. AAA and its radiopharmacy partners around the US have delivered approximately 1,200 doses of NETSPOT® to patients in the first quarter of 2017, and are currently delivering doses at a rate of approximately 800 per month.

Stefano Buono, Chief Executive Officer of AAA stated, “We are honored to be recognized by NORD for the innovation NETSPOT® is bringing to the NET community. We believe NETSPOT® offers superior sensitivity and accuracy compared to previously available diagnostics for NET patients. In a clinical study, NETSPOT® demonstrated the ability to change patient management decisions in 71% of cases imaged with the previously available standard of care.3

In March 2016, NETSPOT® was included in the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology update for the evaluation of NETs.

In December 2016, the Centers for Medicare & Medicaid Services (CMS) granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. The same Healthcare Common Procedure Coding System (HCPCS) “A Code” may be used on claims to private payers.

1 Dasari A, et al. JAMA Oncol. 2017
2 Yao JC, et al. J Clin Oncol. 2008
3 Srirajaskanthan R, et al. J Nucl Med. 2010


NETSPOT® (gallium Ga 68 dotatate) is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. There are no Contraindications for use. Warnings and Precautions include gallium Ga 68 dotatate contributing to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. The safety of gallium Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. No serious adverse reactions were identified. NETSPOT® is available in two forms: As a drug kit for reconstitution using a Ga 68 generator, and as a ready-to-use injection delivered from local radiopharmacies in select metropolitan areas. NETSPOT® has been designated as an orphan drug by the FDA and European Medicines Agency. For full prescribing information for NETSPOT® please refer to:

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 that AAA is currently developing 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 has 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:

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