Products

Advanced Accelerator Applications (AAA) develops, produces and commercializes diagnostic and therapeutic Molecular Nuclear Medicine products in the fields of 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 PET portfolios in Europe (GLUSCAN®, FLUOROCHOL, DOPAVIEW®, CARDIOGEN-82®) and has a growing presence in SPECT, with its own products (MIBITEC and LEUKOKIT®) as well as third-party manufacturer and distributor agreements (NEUROLITE®). AAA also has an important portfolio of PET, SPECT and therapy products in development. SOMAKIT, a PET product, recently received a positive opinion on its Marketing Authorization Application from the European Medicines Agency.

Commercial products

AAA has built a leadership position in Molecular Nuclear Medicine in Europe by manufacturing and commercializing a portfolio of seven diagnostic PET and SPECT products for a number of indications in clinical oncology, cardiology, neurology and inflammatory/infectious diseases. Our main European products are GLUSCAN®, FLUOROCHOL, DOPAVIEW®, CARDIOGEN-82®, MIBITEC, NEUROLITE®, and LEUKOKIT®. In addition, we have a PET product approved in the United States (NETSPOT®).

Product Description Indications Marketing Authorization

NETSPOT®

Kit for the preparation of gallium Ga 68 dotatate injection for intravenous use

NETSPOT®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients

United States

NETSPOT® (formerly known as Somakit-TATE) is a novel patented drug 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. NETSPOT® is the first FDA approved drug using Ga 68 as a positron emitter. For the EU, SomaKit TOC is a novel kit developed by AAA for the radiopharmaceutical preparation of gallium (Ga 68) edotreotide for gastroenteropancreatic neuroendocrine tumor detection. A MAA for SomaKit-TOC was submitted to the EMA in October 2015, and in October 2016, the agency issued a positive opinion.

Kit for the preparation of gallium Ga 68 dotatate injection for intravenous use

NETSPOT®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients

United States

Gluscan® / 
Gluscan 500 / 
Barnascan

Our brand names for FDG  (concentration = 600MBq*/ml and 500MBq*/ml at calibration time for Gluscan® and Gluscan® 500, respectively; 3,000MBq*/ml for Barnascan at calibration time)

PET tracer for oncology, cardiology, neurology and infectious/inflammatory diseases

Gluscan®: Belgium, France, Italy, Luxembourg, 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.

Our brand names for FDG  (concentration = 600MBq*/ml and 500MBq*/ml at calibration time for Gluscan® and Gluscan® 500, respectively; 3,000MBq*/ml for Barnascan at calibration time)

PET tracer for oncology, cardiology, neurology and infectious/inflammatory diseases

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

FLUOROCHOL / AAACHOLINE

Our brand names for 18F-choline (FCH)

PET tracer for detecting metastasis of prostate cancer

Fluorochol: France

AAACholine: Switzerland

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.

Our brand names for 18F-choline (FCH)

PET tracer for detecting metastasis of prostate cancer

Fluorochol: France

AAACholine: Switzerland

DOPAVIEW®

Our brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue

PET tracer for diagnostic use, with key applications in neurology and oncology

France, Switzerland

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.

Our brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue

PET tracer for diagnostic use, with key applications in neurology and oncology

France, Switzerland

CARDIOGEN-82®

A closed system used to produce rubidium Rb 82 chloride injection for intravenous use.

PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Switzerland

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.

A closed system used to produce rubidium Rb 82 chloride injection for intravenous use.

PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

Switzerland

MIBITEC and Adamibi

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

SPECT tracer for myocardial exploration, localization of parathyroid tissue and breast cancer diagnosis

MIBITEC: Austria, France, Germany, Luxembourg, Poland, Slovenia
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.

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

SPECT tracer for myocardial exploration, localization of parathyroid tissue and breast cancer diagnosis

MIBITEC: Austria, France, Germany, Luxembourg, Poland, Slovenia
Adamibi: Greece, Italy

Leukokit®

Medical device for the separation and labeling of autologous leukocytes

Identifies sites of infection or inflammation in the body

CE mark: can be commercialized throughout Europe

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 labeling of autologous leukocytes

Identifies sites of infection or inflammation in the body

CE mark: can be commercialized throughout Europe

NEUROLITE®

A kit for radiopharmaceutical preparation of Technetium (99mTc) Bicisate Injection.

Tc-99m Bicisate scintigraphy is indicated in the evaluation of regional cerebral perfusion abnormalities in adult patients with central nervous system disorders.

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

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

A kit for radiopharmaceutical preparation of Technetium (99mTc) Bicisate Injection.

Tc-99m Bicisate scintigraphy is indicated in the evaluation of regional cerebral perfusion abnormalities in adult patients with central nervous system disorders.

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

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.