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Advanced Accelerator Applications

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Advanced Accelerator Applications
IndustryPharmaceuticals
Founded2002 (2002)
HeadquartersSaint-Genis-Pouilly, France
Key people
Susanne Schaffert, Chairman of the Board of AAA
ProductsGLUSCAN, DOPAVIEW, FLUOROCHOL/AAACHOLINE, NETSPOT, SOMAKIT TOC, CARDIOGEN-82, NEUROLITE, MIBITEC/ADAMIBI, LEUKOKIT
Revenue€109.3 million
Number of employees
>600
Websiteadacap.com

Advanced Accelerator Applications (AAA) is a pharmaceutical group specialized in the field of nuclear medicine.[1] The group operates in all three segments of nuclear medicine (PET, SPECT and therapy) to diagnose and treat serious conditions in the fields of oncology, neurology, cardiology, infectious and inflammatory diseases.[2]

In late October 2017, Reuters announced that Novartis would acquire the company for $3.9 billion, paying $41 per ordinary share and $82 per American depositary share representing a 47 percent premium.[3] On January 22, 2018, Novartis AG (NYSE: NVS) announced the successful completion of the tender offer by its subsidiary, Novartis Groupe France S.A.[4]

History

AAA was created in 2002 by Italian physicist Stefano Buono to exploit a patent from the European Organization for Nuclear Research (CERN).[5]

The group currently has 20 production and research & development facilities that manufacture both diagnostic and therapeutic Molecular Nuclear Medicine products, and over 600 employees in 13 countries (Belgium, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, The Netherlands, UK, Israel, U.S. and Canada).

AAA's Board of Directors includes Frédéric Collet, Jessica Toepfer and Susanne Schaffert.

AAA announced its full-year results for 2016, with sales of €109,3 million (+23% vs. 2015).

Products

AAA has a portfolio of diagnostic and therapeutic applications and products in the fields of Molecular Imaging and Therapy. [6] 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.[7]

Lutathera

The company's lead product is LUTATHERA, a lutetium-177 (Lu-177) 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 Jan 2018 for GEP-NET.[8]

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.[9][10]

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.

177LuPSMA-R2 and 68GaPSMA-R2 are in development to treat, image, monitor and stage prostate cancer. PSMA-R2 is a ligand of Prostate-Specific Membrane Antigen (PSMA), expressed on the majority of prostate tumor cells. 177LuPSMA-R2 is being developed to treat prostate cancer and 68GaPSMA-R2 is under development as its complementary diagnostic candidate.

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.[11] When the site was first purchased, it caused substantial concerns among local residents.[12] 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.[13] The expert concluded that the proposed operations at AAA are safe and pose no hazard to the citizens of Millburn.[14][15]

References

  1. ^ PrivateEquityWire, "Advanced Accelerator Applications completes fundraising", Feb 18th, 2014
  2. ^ Il Sole 24 Ore, “Dal Cern and Biopark canavese”, March 12th, 2014
  3. ^ http://uk.reuters.com/article/uk-novartis-advanced-accelerator/novartis-to-buy-frances-advanced-accelerator-for-3-9-billion-idUKKBN1CZ0KM
  4. ^ Novartis Completes Tender Offer for Advanced Accelerator Applications Jan 2018
  5. ^ AdnKronos,“ Research: from Rubbia to AAA, great success for an Italian physicist with European company”. March 19th, 2010.
  6. ^ Advanced Accelerator Applications Nuclear Medicine Glossary
  7. ^ Medicaldevicedaily.com, “AAA to increase clinical trials of MNM diagnostic products”, Febr 19th, 2014
  8. ^ FDA approves Lutathera for gastroenteropancreatic neuroendocrine tumors Jan 2018
  9. ^ Devicespace.com, “Advanced Accelerator Applications Receives Orphan Drug Designation From FDA And European Medicines Agency For Gallium-68 DOTATATE For Use In Patients With Gastro-Entero-Pancreatic Neuroendocrine Tumors”. 3 March 2014.
  10. ^ News Medical, "AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE". 4 March 2014.
  11. ^ Danielle Desisto. "Millburn manufacturing site safely produces cancer-fighting drug".
  12. ^ "Concerns raised about proposed cancer drug factory in Millburn"
  13. ^ Cecilia Levine. "Nuclear meds expert hired". The Record. 7 May 2015.
  14. ^ Jonathan Sym. "Advanced Accelerator Application Investigation Results: Risks Are “Close To Zero Without Being Zero” Says Expert". Tap Into Millburn/Short Hills. 18 February 2016.
  15. ^ Harry Trumbore. "Expert says radiopharmaceutical factory proposed for Millburn is safe" . 11 February 2016
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