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Advanced Accelerator Applications

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Advanced Accelerator Applications
IndustryPharmaceuticals
Founded2002 (2002)
HeadquartersSaint-Genis-Pouilly, France
Key people
Stefano Buono, CEO - Claudio Costamagna, Chairman
ProductsGLUSCAN® IASOCHOLINE® IASODOPA® IASOFLU® MIBITEC LEUKOKIT®
Revenue€69.9 million
Number of employees
400+
Websiteadacap.com

Advanced Accelerator Applications (AAA) (NASDAQ: AAAP) is a pharmaceutical group specialised in the field of Molecular Nuclear Medicine.[1] The group operates in all three segments of Molecular Nuclear Medicine (PET, SPECT and Therapy) to diagnose and treat serious conditions in the fields of oncology (cancer), neurology, cardiology, infectious and inflammatory diseases.[2]

Molecular Nuclear Medicine is a medical specialty using small amounts of radioactive materials, called radiopharmaceuticals, to diagnose and treat disease. In nuclear medicine imaging, the radiopharmaceuticals are detected by special types of cameras (PET and SPECT) that work with computers to provide very precise pictures of the area of the body being imaged. Nuclear medicine can be used to treat certain types of cancer and other diseases.[3]

Molecular Imaging allows physicians to see how the body is functioning and to measure its chemical and biological processes. Nuclear medicine procedures can often identify abnormalities very early in the progress of a disease — long before many medical problems are apparent with other diagnostic tests.[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] Today AAA trades on the Nasdaq Global Select Market under the ticker “AAAP.” The first day of trading was 11 November 2015. [6]

The group currently has 18 production and research & development facilities that manufacture both diagnostic and therapeutic Molecular Nuclear Medicine products, and over 400 employees in 12 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, the Netherlands, Israel, U.S. and Canada).

AAA’s founder and CEO is Stefano Buono. AAA's Board of Directors includes Dr Yvonne Greenstreet, Steven Gannon, Christian Merle, Leopoldo Zambeletti, Stefano Buono, Kapil Dhingra,[7] Muriel de Szilbereky and Claudio Costamagna.[8] Claudio Costamagna serves as Chairman since June 2012.[9]

AAA announced its full-year results for 2014, with sales of €69.9 million (+29.8% vs. 2013).[10][11]

Products

AAA has a portfolio of diagnostic and therapeutic applications and products in the fields of Molecular Imaging and Therapy. [12] 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.[13]

Pipeline

AAA has a broad pipeline of products in development. The company's lead product in development (phase III), Lu-DOTATATE (Lutathera), is a theragnostic cancer product being developed to treat certain gastro-entero pancreatic neuroendocrine tumors (GEP-NETs).[14] 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.[15] Lutathera was granted Fast-Track designation by the FDA on April 21, 2015 for the treatment of progressive inoperable midgut NETs. Lutathera is currently administered on a compassionate use and named patient basis for the treatment of NETs in ten European countries. Another AAA product in development is radiopharmaceutical Gallium-68 DOTATATE/DOTATOC (Somakit) which received orphan drug designation by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in early 2014, as a diagnostic agent for the management of GEP-NETs.[16][17]

Controversy

AAA has purchased a site to open a light manufacturing site in Millburn, NJ, a residential town in North Jersey. This caused substantial concerns among local residents. [18] Residents expressed their opposition by signing an advocate on Change.org. So far the website has collected more than 800 signatures. Per the requests of Millburn Residents, the Township Committee has hired a nuclear / radiology expert to re-assess the appropriateness of opening a radioactive manufacturing site in the residential area.[19]

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. ^ SNMMI, "About Nuclear Medicine & Molecular Imaging"
  4. ^ SNMMI, "Glossary of Molecular Imaging Terms"
  5. ^ AdnKronos,“ Research: from Rubbia to AAA, great success for an Italian physicist with European company”, March 19th, 2010
  6. ^ Insider Monkey Stocks Hot on the Market on Wednesday 11 November."
  7. ^ Molecular Imaging, "Advanced Accelerator Applications keen on board consult from Kapil Dhingra", May 7th, 2014
  8. ^ Market Watch, "Kapil Dhingra, Former Head of Roche Oncology, Joins AAA Board of Directors", April 29th, 2014
  9. ^ MF Dow Jones, “Claudio Costamagna new Chairman of AAA”, June 21st, 2012
  10. ^ Yahoo Finance,"AAA Reports 29.8% Sales Growth in 2014 While Continuing to Show Significant Clinical Progress Across Both Therapeutic and Diagnostic Platforms", April 9th, 2015
  11. ^ Aunt Minnie, "AAA reports sales boost in 2014", April 10th, 2015
  12. ^ Advanced Accelerator Applications Nuclear Medicine Glossary
  13. ^ Medicaldevicedaily.com, “AAA to increase clinical trials of MNM diagnostic products”,Febr 19th, 2014
  14. ^ European Pharmaceutical Review, "AAA acquires GE Healthcare’s FDG-PET Radiopharmaceutical Business in Italy", Sept 11, 2014
  15. ^ SCRIP Intelligence, “AAA raises €41m to aid US expansion”, Febr 17th, 2014
  16. ^ 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”, March 3rd, 2014
  17. ^ News Medical, "AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE", March 4th, 2014
  18. ^ "Concerns raised about proposed cancer drug factory in Millburn"
  19. ^ "Nuclear meds expert hired"
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