Advanced Accelerator Applications

AAA was created in 2002 by Italian physicist Stefano Buono to exploit a patent from the European Organization for Nuclear Research (CERN). AAA currently has a total of 31 sites in 12 countries, including: 19 production facilities in 8 countries (in Europe and the U.S.) that manufacture targeted radioligand therapies and precision imaging radioligands, and 6 sites with R&D activity. In October 2017, Novartis announced that it intended to acquire the company for US$3.9 billion. The acquisition was completed in January 2018. In January 2024, AAA announced plans to expand manufacturing capabilities and build additional RLT supply facilities in Sasayama, Japan, and Haiyan, Zhejiang, China. In August 2024, Siemens Healthineers bought the diagnostic arm of Advanced Accelerator Applications that specialises in producing radioactive chemicals used for cancer scan for more than $224 million. ==Products==

AAA has a portfolio of diagnostic and therapeutic applications and products in the fields of Molecular Imaging and Therapy. The group's portfolio of radiopharmaceuticals includes radioactive agents for positron emission tomography (PET) imaging as well as single-photon emission computed tomography (SPECT) diagnostic products. Lutathera The company's lead product is LUTATHERA, a Lutetium Lu 177 dotatate labeled somatostatin analogue peptide, a theragnostic cancer product being developed to treat certain gastro-entero pancreatic neuroendocrine tumors (GEP-NETs). It selectively targets over-expressed somatostatin receptors while also giving off gamma emissions to allow physicians to visualize where in the body both the drug and the tumor are. It was approved by the FDA in January 2018 for GEP-NET. Approval Lutathera, also known as lutetium Lu 177 dotatate, is a target treatment drug for patients with GEP-NETs. Its approval for Advanced Accelerator Applications was announced on January 26, 2018, by the US Food and Drug Administration. Lutathera is most notable as the first FDA approved peptide receptor radionuclide therapy (PRRT) to combat GEP-NETs. GEP-NETs GEP-NETs are rare groups of cancer that continue to proliferate, regardless of initial therapy treatments. Mechanism Lutathera is a radioactive drug consisting of a tyrosine-containing somatostatin analog Tyr3-octreotate (TATE) attached to the chelating agent tetraazacyclododecanetetra-acetic acid (DOTA). Attached to the dotatate is the radioactive marker Lu-177, a radioisotope. LysaKare protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide. LysaKare is for use in adults and contains the active substances arginine and lysine. ==Pipeline==

AAA has a broad pipeline of products in development, including several theragnostic pairings for oncology indications. NETSPOT and SomaKit TOC are novel kits for radiolabeling somatostatin analogue peptides to help diagnose somatostatin receptor-positive NET lesions. Each kit has received orphan drug designation from both the EMA and the FDA. 99MTc-rhAnnexin V-128, a SPECT investigational candidate for the diagnosis and assessment of apoptotic and necrotic processes, which are present in a number of pathological conditions in oncology and cardiovascular disease, as well as in autoimmune disorders. 99MTc-rhAnnexin V-128 is currently in a Phase I/II trial for the diagnosis of rheumatoid arthritis and ankylosing spondylitis, as well as several Phase II studies in cardiovascular, cardio-oncology, and pulmonary indications. 177Lu-PSMA-617 and 68Ga-PSMA-617 are in development to treat, image, monitor and stage prostate cancer. PSMA-617 is a ligand of prostate-specific membrane antigen (PSMA) expressed on the majority of prostate tumor cells. 177Lu-PSMA-617 also known as lutetium (177Lu) vipivotide tetraxetan is being developed to treat prostate cancer by binding to PSMA-617. In June 2021 it was granted a breakthrough therapy designation.{{cite web CTT1057 is an 18F-labeled investigational diagnostic candidate in development for PET imaging of prostate cancer. CTT1057 is a phosphoramidate-based peptide, which specifically binds to Prostate-Specific Membrane Antigen (PSMA), expressed on the majority of prostate tumor cells. 177LuNeoBOMB1 and 68GaNeoBOMB1 are new generation antagonist bombesin analogs in development to treat, image, monitor and stage gastrin-releasing peptide receptor (GRPR)-expressing malignancies, such as such as gastrointestinal stromal tumors (GIST), prostate cancer and breast cancer. 177LuNeoBOMB1 is a therapeutic candidate and 68GaNeoBOMB1 is its complementary diagnostic candidate. ==Millburn site==

In 2016, AAA opened a light manufacturing and distribution site in Millburn, NJ, a residential town in North Jersey. When the site was first purchased, it caused substantial concerns among local residents. Per the requests of Millburn Residents, the Township Committee hired a nuclear/radiology expert to re-assess the appropriateness of opening a radioactive manufacturing site in the residential area. The expert concluded that the proposed operations at AAA are safe and pose no hazard to the citizens of Millburn. ==References==