AAA Reports over 24% Growth in Sales for the First Quarter of 2015 – Company receives FDA Fast Track Designation for Lutathera for the treatment of midgut neuroendocrine tumors

Advanced Accelerator Applications announced today its financial results for the first quarter of 2015. The company reported an increase in year-on-year sales of 24.5% for Q1 2015 compared to Q1 2014.

Other key news includes the FDA Fast Track Designation for Lutathera for the treatment of midgut neuroendocrine tumors.

Commenting on the first quarter performance, AAA’s CEO Stefano Buono said: “I am pleased to announce that AAA is performing according to plans or better on both financial and clinical fronts. AAA continues to establish efficiencies in manufacturing, logistics, and financial discipline as we prepare for our global launch of Lutathera.”

We believe that Lutathera provides the potential to significantly impact how physicians treat NETs overexpressing somatostatin receptors in the near future. The Fast Track Designation received from the FDA is an important step in broadening the treatment options for these patients, and highlights the significant impact nuclear medicine can play within the treatment paradigm. We expect the results to demonstrate a clinically important and statistically robust improvement in progression-free survival for patients treated with Lutathera.”

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.

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.