November 20, 2014

AAA Reports Over 25% Growth in Sales for the First Nine Months of 2014

Advanced Accelerator Applications announced today its results for the first nine months of 2014, with sales of €50.2 million (+28.9% vs. 9 months 2013).

Commenting on the nine month results, AAA’s CEO Stefano Buono said: “Demand for our products is strong. We have seen growth across Europe, encouragingly in both established and new markets. With the recruitment for the Phase III trial for our key product candidate Lutathera reaching final stages, we are well positioned going into the final quarter of 2014.”

In the third quarter of 2014 AAA strengthened its position in the European radiopharmaceutical market with the acquisition of GE Healthcare’s FDG-PET (fluorodeoxyglucose photon emission tomography) radiopharmaceutical business in Italy. With this acquisition AAA reinforced its position as one of the leading companies in the PET market in Italy. AAA further consolidated its network in Europe with its production sites in Warsaw, Poland, and in Bonn, Germany both starting commercial operations on 15 September 2014.

AAA’s proprietary pipeline progressed with NETTER-1, the pivotal Phase III trial for Lutathera, on-track with 201 patients randomized to date and the completion of recruitment planned for the end of 2014. The study will include a total of 230 patients.

Other key pipeline products Somakit, Lutathera’s companion PET diagnostic candidate, and Annexin V-128, a SPECT (Single Photon Emission Tomography) product candidate for the imaging of apoptotic and necrotic lesions with applications in a broad range of indications such as rheumatoid arthritis, are also progressing well.

September 11, 2014

AAA Acquires GE Healthcare’s FDG-PET Radiopharmaceutical Business in Italy

Advanced Accelerator Applications announced today that it has entered into an agreement with GE Healthcare in Italy to acquire its Italian FDG-PET imaging agent business (fluorodeoxyglucose photon emission tomography). This acquisition includes the licence to market GE Healthcare’s SteriPET® (FDG) imaging agent in Italy. With this acquisition AAA reinforces its position as one of the leading companies in the PET market in Italy.

Stefano Buono, Chief Executive Officer of AAA, commented: “This acquisition is in line with AAA’s growth strategy of further consolidating our position as a leading pan-European nuclear diagnostics company, alongside exploring additional product pipeline opportunities and avenues for expansion in the United States and outside Europe.”

July 10, 2014

AAA Reports Full-Year 2013 Financial Results: Company Reports Over 30% Growth in Sales

Advanced Accelerator Applications announced today its results for the financial year 2013, with sales of €53.8 million (+31.77% vs. 2012). Other key news includes the appointment of four new Directors to AAA’s Board.

2013 was a very good year for AAA. We exceeded our financial targets with strong demand for our existing products and we consolidated our presence in Europe. With Lu-DOTATATE, our product candidate currently in Phase III, we believe we are well positioned for future success,” said CEO Stefano Buono.

Dr Yvonne Greenstreet, Steven Gannon, Christian Merle and Leopoldo Zambeletti joined Stefano Buono, Kapil Dhingra, Muriel de Szilbereky and Claudio Costamagna to form a new eight person Board of Directors chaired by Claudio Costamagna.

Gerard Ber, Heinz Mausli, Eugenio Aringhieri, Andrea Ruben Levi and Raffaele Petrone stepped down from the Board.

As the business of AAA becomes increasingly global, Board members with their breadth of experience are essential assets to the organization. These highly successful leaders will play a vital role in guiding AAA in its mission to become a leading global player in MNM.

April 29, 2014

Kapil Dhingra, Former Head of Roche Oncology, Joins AAA Board of Directors

Advanced Accelerator Applications announces that Dr Kapil Dhingra has joined the Company Board of Directors as an Independent Non-Executive Director.

Dr. Dhingra’s guidance and perspective on clinical development, regulatory and commercial strategy will be of tremendous benefit as we advance our pipeline of product candidates and our lead product candidate, Lu-DOTATATE (Lutathera®), currently in a pivotal Phase III trial for the treatment of gastro-entero-pancreatic neuroendocrine tumors (“GEP-NETs”).

Dr Dhingra has over 25 years’ experience in oncology clinical research and drug development, including nine years at Roche Pharmaceuticals, where he played a key role in the expansion of Roche Oncology. From 1999 to 2008 he served in positions of increasing responsibility at Roche, including Vice President, Head, Oncology Disease Biology Leadership Team, and Head, Oncology Clinical Development.

Prior to his time at Roche, Dr. Dhingra worked in the oncology clinical development group atEli Lilly and Company. He has also previously served as a Clinical Instructor, Assistant Professor of Medicine at the University of Texas M.D. Anderson Cancer Center. Dr. Dhingra holds an M.B.,B.S. (equivalent to a U.S. M.D.) degree from the All India Institute of Medical Sciences. He is Board-certified in Internal Medicine and Medical Oncology.

Dr Dhingra is Head of KAPital Consulting, a healthcare consulting firm he founded in 2008, dedicated to helping biotechnology, pharmaceutical and diagnostic companies realize the clinical and commercial advances in oncology. Dr. Dhingra is currently an advisor to and/or member of the board of directors of several biotechnology and pharmaceutical companies and organizations. He has previously served on the Boards of several successful biotech companies, including Biovex, Micromet, Algeta, and YM Biosciences, which were acquired by major pharmaceutical companies.

The AAA Board is chaired by Claudio Costamagna and consists of nine Directors.

April 15, 2014

AAA opens new office in the US

Advanced Accelerator Applications announces that it has officially opened a new office in the US. The office is in the heart of Manhattan in New York City.

This is an important step for AAA as the US is a key market for molecular nuclear medicine with nearly half of all nuclear medicine procedures worldwide taking place in the US. The aim is to accelerate the company’s international growth and further expand its presence and activities in the US as it is advancing in its phase III clinical trial for its lead product Lu-DOTATATE for the treatment of Gastro-Entero-Pancreatic Neuro Endocrine Tumors (GEP-NETs).

AAA’s New York office is located in the Empire State Building and will initially host a few employees, including the company’s CEO. The company aims to grow its East Coast-based team to up to thirty people in the next 2 years to support its clinical studies for Ga68-DOTATATE (Somakit) and Annexin. AAA’s New York office will also be heading all developments linked to the setting up of a new manufacturing facility in the US and the launch of AAA’s commercial activity in the US.

March 4, 2014

AAA enters UK and Irish nuclear medicine markets with the acquisition of Imaging Equipment Ltd

Advanced Accelerator Applications announces that it has acquired 100% of IEL in newly issued AAA shares. The acquisition gives AAA its first direct presence in the UK and Ireland, expanding its existing services and expertise in nuclear medicine and providing it with an established sales and marketing platform.

The UK’s nuclear medicine market is one of the largest in Europe, with annual sales of more than €120 million. IEL generated sales of almost £6.77 million for the year ended 31 December 2013, up 58% on 2012.

As part of the transaction, IEL’s founding shareholders and top management will become shareholders in AAA, which demonstrates the commitment to continuity and the shared common views in terms of development and value creation.

AAA receives orphan drug designation from FDA and EMA for Gallium-68 DOTATATE

Advanced Accelerator Applications announces that they have received orphan drug designation status for their radiopharmaceutical, Gallium-68 DOTATATE. The orphan drug designation has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use of Gallium-68 DOTATATE as a diagnostic agent for the management of Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs). The designation should foster rapid development of the agent for the benefit of GEP-NET patients in the U.S. and Europe.

Gallium-68 DOTATATE will be prepared using AAA’s patented kit, which is reconstituted in hospital radiopharmacies without the use of a radiochemistry module, thus making the product available to all hospitals, even those who do not have a fully equipped GMP production radiopharmacy unit.

February 17, 2014

AAA completes €41 million fund raising

Advanced Accelerator Applications announces that it has successfully completed a capital increase of €41 million.

This capital increase will help accelerate AAA’s international expansion, including an increased presence in the US and help finance the clinical development of its promising portfolio of innovative Molecular Nuclear Medicine diagnostic and therapeutic products.

Specialist biotech and pharma investment company HBM Healthcare Investments Ltd led the investment with €20 million. Other investors include existing and new shareholders such as a company of the Tamburi Investment Partners Group.

January 9, 2014

AAA to present at J.P. Morgan Healthcare Conference

Advanced Accelerator Applications will be presenting at the 32nd Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 14, 2014. Stefano Buono, Chief Executive Officer of AAA, will be making a formal presentation on the company at 8:00am CST in San Francisco, California.

Stefano Buono will present an overview of AAA, its products and business goals to an audience of institutional investors, venture capital companies, global industry leaders, innovative technology creators, private investors, industry executives and private equity firms. This year approximately 300 companies, both public and private, will be presenting to over 4,000 investors.