Products

Advanced Accelerator Applications (AAA) is a leader in the development of molecular nuclear medicine diagnostics and therapeutics.

Our expertise is built on a 15-year legacy of manufacturing and commercializing a portfolio of PET and SPECT products for a number of indications in oncology, neurology, cardiology and infectious & inflammatory diseases.

AAA produces and delivers both commercial drugs and research products for clinical or pre-clinical studies. AAA laboratories are GMP certified for the manufacturing of Investigational Medical Products (IMP).

AAA has one of the broadest commercial PET portfolios in Europe (GLUSCAN®, SOMAKIT TOC®, FLUOROCHOL, DOPAVIEW®, CARDIOGEN-82®), as well as third party manufacturing agreements; and has a growing presence in SPECT, with its own products (MIBITEC and LEUKOKIT®) and distributor agreements (NEUROLITE®). AAA’s first PET product in the United States, NETSPOT® (gallium Ga 68 dotatate) was approved in 2016. In 2017, AAA’s first therapeutic product, LUTATHERA® (USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide) was approved in Europe in 2017 and in the United States in 2018.

Product Description Disease Marketing Authorization

LUTATHERA® (US only)

Our brand name for lutetium Lu 177 dotatate

For more information, please visit www.LUTATHERA.com

United States

Our brand name for lutetium Lu 177 dotatate

For more information, please visit www.LUTATHERA.com

United States

LUTATHERA® (EU only)

Our brand name for lutetium (177Lu) oxodotreotide

For more information, please visit www.LUTATHERA.com

All EU countries, Norway, Iceland, Liechtenstein

Our brand name for lutetium (177Lu) oxodotreotide

For more information, please visit www.LUTATHERA.com

All EU countries, Norway, Iceland, Liechtenstein

NETSPOT®

Kit for the preparation of gallium Ga 68 dotatate injection

For more information, please see US patient brochure

United States

Kit for the preparation of gallium Ga 68 dotatate injection

For more information, please see US patient brochure

United States

SOMAKIT TOC®

Kit for the preparation of gallium (Ga 68) edotreotide solution

For more information, please see Summary of Product Characteristics

All EU countries, Norway, Iceland, Liechtenstein

Kit for the preparation of gallium (Ga 68) edotreotide solution

For more information, please see Summary of Product Characteristics

All EU countries, Norway, Iceland, Liechtenstein

Gluscan / Gluscan 500 / Barnascan

AAA brand names for FDG (most widely used PET tracer)

Oncology
Cardiology
Neurology
Infectious and inflammatory diseases

Gluscan: Belgium, France, Germany, Italy, Luxemburg, Portugal, Spain, Switzerland
Gluscan 500: France, Germany, Poland, Portugal, Spain
Barnascan: Spain

GLUSCAN®, which includes GLUSCAN® 500 and Barnascan, is our leading PET product. Its active ingredient is FDG-18, or FDG, the most widely used PET tracer. GLUSCAN® contains a radioactive marker that enables the detection of a number of conditions in oncology, neurology, cardiology and inflammatory and infectious disease.

We manufacture and organize distribution for GLUSCAN® from our production sites in France, Italy, Portugal, Spain, Germany and Poland.

We are a leading supplier of FDG in Europe, and develop, manufacture and distribute our FDG products in an integrated fashion through our operating facilities, enabling reliable production, service and delivery to nuclear medicine end-users.

AAA brand names for FDG (most widely used PET tracer)

Oncology
Cardiology
Neurology
Infectious and inflammatory diseases

Gluscan: Belgium, France, Germany, Italy, Luxemburg, Portugal, Spain, Switzerland
Gluscan 500: France, Germany, Poland, Portugal, Spain
Barnascan: Spain

FLUOROCHOL / AAACHOLINE / CHOLSCAN

AAA brand name for [18F]-choline (FCH)

Oncology

Fluorochol: Austria, France, Germany, Poland
AAACholine: Switzerland
Cholscan: Italy, Spain

This drug is purely for diagnostic use. 18F-choline (FCH) is intended for Positron Emission Tomography (PET). Both FLUOROCHOL and AAACHOLINE are indicated for imaging in patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced choline influx of specific organs or tissues is the diagnostic target. The main indication is the initial staging and restaging of prostate cancer in case of biochemical recurrence. In addition, FLUOROCHOL is indicated for the localization of lesions of proven and well-differentiated hepatocellular carcinoma, and the characterization and/or staging of hepatocellular carcinoma, when FDG PET is non-conclusive and/or when surgery is scheduled.

AAA brand name for [18F]-choline (FCH)

Oncology

Fluorochol: Austria, France, Germany, Poland
AAACholine: Switzerland
Cholscan: Italy, Spain

DOPAVIEW

AAA brand name for 6-fluoro-[18F]-L-DOPA, a DOPA analog

Neurology
Oncology

Belgium, France, Italy, Luxemburg, Netherlands, Portugal, Spain, Switzerland, UK

6-fluoro-(18F)-L-DOPA, is an analogue of DOPA, an aromatic amino acid that accumulates rapidly in target tissues particularly the striatum of human brain and is transformed into dopamine, a neurotransmitter from the catecholamine group.   This drug is purely for diagnostic use. In neurology, PET with DOPAVIEW® is indicated for detection of a functional loss of dopaminergic nerve endings in the striatum. It can be used for diagnosing Parkinson's disease and for the differentiation between essential tremor and parkinsonian syndromes. In oncology, among the various imaging studies, PET with DOPAVIEW® enables a functional approach to pathologies, organs or tissues in which increased intracellular transport and decarboxylation of the amino acid dihydroxyphenylalanine (DOPA) is being investigated.   The following indications have been documented in the greatest detail:

  • Diagnosis, localization, staging and detection of recurrences or residual disease of pheochromocytomas and paragangliomas,
  • Diagnosis and localization of beta-cell hyperplasia in cases of hyperinsulinism in infants and children,
  • Staging and detection of recurrences or residual disease of well-differentiated midgut neuroendocrine tumors,
  • Detection of recurrences or residual disease of cerebral gliomas, medullary thyroid cancer and other digestive neuroendocrine tumors when the imaging of somatostatin receptors is negative.

AAA brand name for 6-fluoro-[18F]-L-DOPA, a DOPA analog

Neurology
Oncology

Belgium, France, Italy, Luxemburg, Netherlands, Portugal, Spain, Switzerland, UK

CARDIOGEN-82®

Closed system used to produce rubidium Rb 82 chloride for intravenous use

Cardiology

Switzerland
License to distribute in Europe

CARDIOGEN-82® (rubidium Rb-82) is a myocardial perfusion PET imaging agent for the detection and evaluation of coronary artery disease with Myocardial Perfusion Imaging. It offers a safe, non-invasive alternative to angiography and provides excellent detection of the disease, improved efficiency, lower radiation exposure, fewer attenuation artefacts and improved resolution. AAA has the exclusive distribution license for CARDIOGEN-82® in Europe. CARDIOGEN-82® is approved for use in the U.S. where it is manufactured by Bracco Diagnostics Inc.

Closed system used to produce rubidium Rb 82 chloride for intravenous use

Cardiology

Switzerland
License to distribute in Europe

MIBITEC / Adamibi

AAA brand names for a generic version of a widely-used SPECT cardiac imaging agent

Cardiology
Endocrinology
Oncology

MIBITEC: Austria, France
Adamibi: Greece, Italy

MIBITEC and Adamibi are our brand names for a generic version of the most widely used SPECT cardiac imaging agent, Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate. They are approved for myocardial exploration, localization of parathyroid tissue and breast cancer diagnosis. MIBITEC was first launched in France in late 2010 and its marketing authorization has been extended to Austria, Germany, Poland, Luxembourg and Slovenia. We also market it in Greece and Italy under the name Adamibi. We intend to expand our sales of MIBITEC and Adamibi by selling them in new markets and are currently seeking marketing authorizations for MIBITEC and Adamibi in other European countries.

AAA brand names for a generic version of a widely-used SPECT cardiac imaging agent

Cardiology
Endocrinology
Oncology

MIBITEC: Austria, France
Adamibi: Greece, Italy

Leukokit

Medical device for the separation and labelling of autologous leukocytes

Infection/Inflammation

CE Mark

LEUKOKIT® is a registered single-use medical device that contains all the necessary materials (with the exception of the radiopharmaceutical agent) to carry out separation and labeling of autologous leukocytes. The resulting labelled leukocytes are administered to patients to identify sites of infection or inflammation in the body. The use of LEUKOKIT® simplifies the procedure for identifying such sites and improves the operator’s safety and the microbiological quality of the labeled cell preparation. Its use only requires a bench centrifuge, basic equipment often present in laboratories, enabling radiolabeling without expensive equipment. LEUKOKIT® meets the essential requirements of all relevant European Medical Device Directives and carries the CE-mark, a legal requirement permitting the marketing of a medical device throughout the European Union.

Medical device for the separation and labelling of autologous leukocytes

Infection/Inflammation

CE Mark

NEUROLITE

Kit for radiopharmaceutical preparation of Technetium (99mTc) Bicisate Injection

Central Nervous System

Held by Lantheus MI UK, Ltd.; AAA distribution in France, Spain, Switzerland

AAA has an exclusive distribution license for NEUROLITE® in France and Spain.

Kit for radiopharmaceutical preparation of Technetium (99mTc) Bicisate Injection

Central Nervous System

Held by Lantheus MI UK, Ltd.; AAA distribution in France, Spain, Switzerland

LuMark®

Our licensed brand name for cGMP produced Lutetium-177, a radiopharmaceutical precursor

NA

All EU countries, Norway, Iceland, Liechtenstein

IDB Holland bv (a AAA company) produces, markets and sells LuMark® Lu-177 chloride, 80 GBq/mL. Our Lu-177 has received European Marketing Authorization as a radiopharmaceutical precursor. Lutetium-177 is an emitter of high-energy beta particles (used for many years in radiation oncology to treat solid cancers) that can be effectively used to deliver toxic effects to metastatic cancers. Currently IDB is distributing Lu-177 chloride worldwide.

Our licensed brand name for cGMP produced Lutetium-177, a radiopharmaceutical precursor

NA

All EU countries, Norway, Iceland, Liechtenstein

* MBq refers to a megabecquerel, a unit of radiation measurement.