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.”

Kapil Dhingra, Former Head of Roche Oncology, Joins Advanced Accelerator Applications 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.

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 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.

AAA reaches halfway recruitment milestone of cancer patients in Lutathera® Pivotal Phase III trial

Advanced Accelerator Applications has reached the 100-patient (halfway) milestone for the NETTER-1 study, an international Phase III clinical trial evaluating the effect of Lutathera® in patients with inoperable progressive midgut carcinoid tumors. The primary endpoint of the trial is the assessment of Progression-Free Survival, with secondary endpoints including Safety, Objective Response Rate, Time to Tumor Progression, Overall Survival and Quality of Life. Lutathera is the first theragnostic drug in MNM to enter phase III clinical development. Its efficacy can be imaged and evaluated at each of a total of four treatments via a SPECT camera, with no additional cost. Phase II results showed Progression-Free Survival of over 45 months compared to the reported 14.6 months of Novartis’ Sandostatin® LAR. Lutathera is currently used on a named patient basis pre-marketing sales in eight European countries.