Advanced Accelerator Applications

Advanced Accelerator Applications
Industry Pharmaceuticals
Founded 2002 (2002)
Headquarters Saint-Genis-Pouilly, France
Key people
 Stefano Buono, CEO - Claudio Costamagna, Chairman
Products GLUSCAN® DOPAVIEW IASOCHOLINE® IASODOPA® IASOFLU® MIBITEC LEUKOKIT®
Revenue €88.6 million
Number of employees
 >460
Website adacap.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 22 production and research & development facilities that manufacture both diagnostic and therapeutic Molecular Nuclear Medicine products, and over 470 employees in 13 countries (Belgium, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, The Netherlands, UK, Israel, U.S. and Canada).

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

AAA announced its full-year results for 2015, with sales of €88.6 million (+26.8% vs. 2014).[10]

Products

AAA has a portfolio of diagnostic and therapeutic applications and products in the fields of Molecular Imaging and Therapy. [11] 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.[12]

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).[13] 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.[14] Lutathera was granted Fast-Track designation by the US Food and Drug Administration on 21 April 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. Somakit-TATE (now marketed as NETSPOT™) and Somakit-TOC are novel kits in development 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.[15][16] In June 2016, the FDA approved NETSPOT™ (SOMAKIT-TATE). Somakit-TOC is being developed following the same regulatory path as that of NETSPOT™. The company submitted a MAA to the EMA for Somakit-TOC in October 2015.

Millburn site 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.[17] 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 hired a nuclear/radiology expert to re-assess the appropriateness of opening a radioactive manufacturing site in the residential area.[18] The expert concluded that the proposed operations at AAA are safe and pose no hazard to the citizens of Millburn.[19][20]

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. ↑ Kathy Mahdoubi. Molecular Imaging, "Advanced Accelerator Applications keen on board consult from Kapil Dhingra". May 7, 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,"Advanced Accelerator Applications reports 26.8% sales growth in 2015 and continues to show significant clinical progress across both therapeutic and diagnostic platforms", April 29th, 2016
  11. ↑ Advanced Accelerator Applications Nuclear Medicine Glossary
  12. ↑ Medicaldevicedaily.com, “AAA to increase clinical trials of MNM diagnostic products”,Febr 19th, 2014
  13. ↑ European Pharmaceutical Review, "AAA acquires GE Healthcare’s FDG-PET Radiopharmaceutical Business in Italy". 11 September.
  14. ↑ SCRIP Intelligence, “AAA raises €41m to aid US expansion” Archived April 9, 2014, at the Wayback Machine.. 17 February 2014.
  15. ↑ 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.
  16. ↑ News Medical, "AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE". 4 March 2014.
  17. ↑ "Concerns raised about proposed cancer drug factory in Millburn"
  18. ↑ Cecilia Levine. "Nuclear meds expert hired". The Record. 7 May 2015.
  19. ↑ 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.
  20. ↑ Harry Trumbore. "Expert says radiopharmaceutical factory proposed for Millburn is safe". The Record. 11 February 2016.

External links

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