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.