Advanced Accelerator Applications today announced the pricing of its initial public offering of 4,688,000 American Depositary Shares (“ADSs”) representing 9,376,000 of its ordinary shares at a price of $16.00 per ADS. The ADSs are expected to begin trading on the Nasdaq Global Select Market on November 11, 2015 under the ticker “AAAP.” All of the ADSs are being offered by AAA. In addition, AAA has granted the underwriters a 30-day option to purchase up to 703,200 additional ADSs from the Company at the initial public offering price, less underwriting discounts.

Citigroup Global Markets Inc. and Jefferies LLC are acting as joint book-running managers for the offering. Canaccord Genuity Inc. and JMP Securities LLC are acting as co-managers.

A registration statement relating to these securities has been filed with, and declared effective by, the Securities and Exchange Commission.

Advanced Accelerator Applications announced today at ECC 2015 that the pivotal Phase 3 NETTER-1 study for Lutathera (177Lu-DOTATATE) met its primary endpoint of assessing progression-free survival (PFS), demonstrating that Lutathera significantly improved PFS when compared with Sandostatin LAR 60mg (Octreotide LAR) in patients with advanced midgut neuroendocrine tumors (NETs).

The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% of disease progression or death versus a treatment with a double dose of Octreotide LAR (hazard ratio 0.21, 95% CI: 0.13-0.34; p<0.0001). The median PFS in the Lutathera arm is not yet reached, whilst the median PFS in the Octreotide LAR 60 mg arm was 8.4 months. The adverse events observed on Lutathera in NETTER-1 are consistent with the results of Lutathera’s previous Phase I-II study, with Lutathera demonstrating a favorable safety profile.

“NETTER-1 is the first large scale, multinational Phase 3 trial to demonstrate the efficacy of Lutathera in patients with advanced midgut NETs,” said Stefano Buono, Chief Executive Officer of AAA. “We are very pleased with the favorable results demonstrated in the study. We believe that Lutathera has the potential to provide a clinically significant benefit for patients and improve the standard of care for this disease.”

Prof. Philippe Ruszniewski, Gastroenterology-Pancreatology Dept, Beaujon Hospital, Clichy, and Dean of the School of Medicine at Paris Diderot University (France), a study investigator commented: “The NETTER-1 results demonstrate a clinically important and statistically significant increase in progression-free survival for patients with advanced midgut NETs treated with Lutathera. This is the first time a Phase 3 clinical trial has demonstrated an increased PFS with PRRT in the treatment of GEP-NETs.”

The results were presented in late-breaking abstract 6LBA “177-Lu-Dotatate significantly improves progression-free survival in patients with mid gut neuroendocrine tumors: Results of the phase III NETTER-1 trial.” This abstract was presented today at the European Cancer Congress in Vienna during Presidential Session II.

AAA has entered into a distribution agreement for Lutathera in Japan with FUJIFILM RI Pharma, Co., LTD (“FRI”), a leading in-country distributor of nuclear medicine and diagnostic imaging products. Lutathera is currently in a pivotal Phase III trial, both in the US and EU, with results expected in Q3.

FRI provides important sales, marketing and distribution capabilities for Lutathera in the Japanese market as well as providing the support needed to gain regulatory clearance in Japan. We believe Asia is a significant market for Lutathera, and Japan represents an important first presence as we introduce the product into the region.

As part of the agreement, AAA will receive launch and development milestone payments, in addition to royalties on product sales. Lutathera will be manufactured by AAA in Europe and sold by its subsidiary AAA International to FRI.

In Europe’s five key markets and the US, AAA’s plan is to build complete and dedicated commercial structures in each country to support the launch and promotion of Lutathera and Somakit, Lutathera’s companion diagnostic, for which a New Drug Application (NDA) will soon be submitted to the FDA. Our plans are to continue implementing selected distributorships such as our agreement with FRI, in countries where we have not planned a direct presence.

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.”

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.

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.”