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® FLUOROCHOL NETSPOT® CARDIOGEN-82® NEUROLITE® MIBITEC LEUKOKIT®
Revenue €109.3 million
Number of employees
 >500
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 21 production and research & development facilities that manufacture both diagnostic and therapeutic Molecular Nuclear Medicine products, and over 530 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 Steven Gannon, Christian Merle, Christine Mikail, 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 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. [10] 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.[11]

Pipeline

AAA has a broad pipeline of products in development, including several theragnostic pairings for oncology indications.

Lutathera

The company's lead product in development (in regulatory review), Lutathera, a lutetium-177 (Lu-177) labeled somatostatin analogue peptide, is 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. Lutathera is currently administered on a compassionate use and named patient basis for the treatment of NETs in ten European countries and the U.S.[12]

Other

Somakit-Tate (now marketed as 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.[13][14] In June 2016, the FDA approved NETSPOT® (Somakit-Tate) and in December 2016, the European Commission approved Somakit-TOC™.

Millburn site

In 2016, AAA opened a light manufacturing and distribution site in Millburn, NJ, a residential town in North Jersey.[15] When the site was first purchased, it caused substantial concerns among local residents.[16] 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.[17] The expert concluded that the proposed operations at AAA are safe and pose no hazard to the citizens of Millburn.[18][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. ↑ 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. ↑ Advanced Accelerator Applications Nuclear Medicine Glossary
  11. ↑ Medicaldevicedaily.com, “AAA to increase clinical trials of MNM diagnostic products”, Febr 19th, 2014
  12. ↑ "Expanded Access Protocol for Therapeutic Use of 177Lu-DOTA0-Tyr3-Octreotate in Patients With Inoperable, Somatostatin Receptor Positive, Midgut Carcinoid Tumors, Progressive Under Somatostatin Analogue Therapy".
  13. ↑ 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.
  14. ↑ News Medical, "AAA gets orphan drug designation status for radiopharmaceutical, Gallium-68 DOTATATE". 4 March 2014.
  15. ↑ Danielle Desisto. "Millburn manufacturing site safely produces cancer-fighting drug".
  16. ↑ "Concerns raised about proposed cancer drug factory in Millburn"
  17. ↑ Cecilia Levine. "Nuclear meds expert hired". The Record. 7 May 2015.
  18. ↑ 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.
  19. ↑ Harry Trumbore. "Expert says radiopharmaceutical factory proposed for Millburn is safe" . 11 February 2016
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