News

December 10, 2015

AAA Reports 37% Growth in Sales for the Third Quarter of 2015 and 32% Growth in Sales for the first nine months of 2015

Advanced Accelerator Applications S.A. (NASDAQ:AAAP) today announced its financial results for the third quarter and the first nine months of 2015. Commenting on the third quarter performance, AAA’s CEO Stefano Buono said: “We are entering a new phase at AAA, and the third quarter was a pivotal and exciting time for our company. With the announcement of positive Phase 3 results from the NETTER-1 trial in September, and the subsequent completion of a successful initial public offering in November, we believe we are well positioned to advance the development of our lead drug candidate Lutathera in patients with advanced midgut neuroendocrine tumors. Additionally, we plan to file a New Drug Application (“NDA”) with the U.S Food and Drug Administration and a Marketing Authorization Application (“MAA”) in the European Union for Lutathera by the end of the first quarter of 2016.“

Recent Highlights:
– Reported of an increase in year-over-year sales of approximately 37% for Q3 2015 compared to Q3 2014
– Reported an increase in year-over-year sales of approximately 32% for the first nine months of 2015 compared to the first nine months of 2014
– Completed an Initial Public Offering (“IPO”) and listed on the Nasdaq Global Select Market under the ticker “AAAP”
– Announced positive results from Phase 3 NETTER-1 study, evaluating lead drug candidate Lutathera in patients with advanced midgut neuroendocrine tumors
– Obtained two Marketing Authorizations in France for FCholine and FDopa
– Received FDA Priority Review for Somakit-TATE New Drug Application
– Submitted MA application to EMA for Somakit-TOC

November 13, 2015

Advanced Accelerator Applications to Ring the Nasdaq Stock Market Opening Bell in Celebration of Its IPO

Advanced Accelerator Applications S.A. (Nasdaq:AAAP) will visit the Nasdaq MarketSite in Times Square today November 13th in celebration of its initial public offering (IPO), which occurred on Wednesday, November 11.

In honor of the occasion, Stefano Buono, Chief Executive Officer will ring the Opening Bell.

Where: Nasdaq MarketSite – 4 Times Square – 43rd & Broadway – Broadcast Studio

When: Friday, November 13, 2015 – 9:15 a.m. to 9:30 a.m. ET

A webcast of the Nasdaq Opening Bell will be available at: https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

After the event the video will be available at: http://business.nasdaq.com/discover/market-bell-ceremonies/detail.html#!/!?ceremonyId=4955

November 10, 2015

Advanced Accelerator Applications S.A. Announces Pricing of Initial Public Offering

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.

September 27, 2015

AAA Announces Positive Results From Phase 3 Study NETTER-1 Evaluating Lutathera in Patients with Advanced Midgut Neuroendocrine Tumors

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.

September 16, 2015

AAA Announces Pivotal Phase 3 NETTER-1 Study of Lutathera in Patients with Midgut NETs Meets Primary Endpoint. Data will be Presented at ECC 2015.

Advanced Accelerator Applications announced today that the pivotal Phase 3 NETTER-1 clinical study investigating the treatment of Lutathera in patients with inoperable, progressive, somatostatin receptor positive midgut Neuro Endocrine Tumors (midgut NETs) has met its primary endpoint, demonstrating a statistically significant and clinically meaningful increase in progression-free survival for Lutathera versus a double dose of Sandostatin LAR. The pivotal Phase 3 study results will be presented for the first time on Sunday, September 27, 2015, at the European Cancer Congress (ECC) 2015 in Vienna, Austria.

The late-breaking abstract was chosen to be presented in one of three Presidential sessions, and has also been selected to be featured as part of the official media program at ECC 2015.

Other important news announced by AAA today is that the U.S. Food and Drug Administration (FDA) has granted Priority Review to AAA’s New Drug Application (NDA) for SomaKit-TATE, Lutathera’s companion PET (Positron Emission Tomography) Diagnostic.

Stefano Buono, Chief Executive Officer of AAA, commented: “We believe that Somakit and Lutathera, if approved, have the potential to provide significant improvement in the treatment of GEP-NET patients.”

June 30, 2015

AAA Signs Distribution Agreement for Lutathera in Japan with FUJIFILM RI Pharma, Co., LTD

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.

June 23, 2015

Advanced Accelerator Applications completes €23 million crossover financing with US-based institutions

AAA has completed a capital increase of €23 million (approx. $26 million), led by Adage Capital Management, LP (Adage). Alongside Adage as new investors in AAA are certain funds and accounts managed by T. Rowe Price Associates, Inc., and Rock Springs Capital Management LP.

Stefano Buono, Chief Executive Officer of AAA commented: “We are very pleased to have completed this pivotal capital increase, with the support of a strategic group of top US healthcare investors. This financing is a critical milestone for us, as we prepare for the Phase III trial results for Lutathera, and the continued progress of our Molecular Nuclear Medicine pipeline.”

June 15, 2015

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.”

April 9, 2015

AAA Reports Full-Year 2014 Financial Results: Company Reports 29.8% Growth in Sales

Advanced Accelerator Applications announced today its Q4 and full year 2014 financial results. The company reported an increase in year-on-year sales of 29.8% for the full-year and 32% for Q4 2014 compared to Q4 2013. For the year ended 31 December 2014 total sales were €69.9 million (+29.8% vs. 2013).

Other key news includes the completion of enrollment in the Lutathera Phase III Trial with pivotal data expected in 2015.

Mr. Stefano Buono, AAA’s CEO, commented, “2014 was a very successful year for AAA. We continued our trend of significant revenue growth, while also completing enrollment of our Phase III clinical trial for therapeutic candidate Lutathera. We anticipate presenting topline data in the second half of 2015 and expect to file both a New Drug Application (NDA) with the U.S. FDA and a Marketing Authorization Application (MAA) with the EMA within 2016. Another achievement was gaining the orphan drug designation in the U.S. and Europe for Somakit, which will be used as a companion diagnostic for Lutathera. We plan to file an NDA and MAA for this product by the end of 2015.

Mr. Buono concluded, “Looking ahead, with a significantly strengthened balance sheet following a successful capital raise in February 2014, and having both consolidated and diversified our revenue stream through strategic acquisitions, we are well positioned to further develop and expand our pipeline of radiopharmaceuticals.

January 8, 2015

AAA fully acquires Atreus Pharmaceuticals and enrolls first patient in a Phase I/II clinical trial for Annexin V-128

Advanced Accelerator Applications is pleased to announce that it has acquired the remaining 49.9% of Atreus Pharmaceuticals Corporation, a development-stage biopharmaceutical company headquartered in Ottawa, Canada and focused on the development of proprietary molecular imaging products aimed at imaging apoptosis and necrosis based on Annexin V. Atreus Pharmaceuticals Corporation is now a fully owned AAA subsidiary and has been renamed AAA Canada.

AAA also announces the enrollment of the first patient in the Phase I/IIa clinical trial to evaluate the safety, pharmacokinetics and dosing of key diagnostic product candidate 99mTc-rhAnnexin V-128 in patients with rheumatoid arthritis or ankylosing spondylitis. The study will also assess the ability of 99mTc-rhAnnexin V-128 to identify the disease and to monitor the effectiveness of current drug treatment. 99mTc-rhAnnexin V-128 is a single photon emission computed tomography (SPECT) radiopharmaceutical agent being developed to detect early cell stress and apoptosis (programmed cell death) in a number of pathological conditions including rheumatoid arthritis and ankylosing spondylitis.

Stefano Buono, Chief Executive Officer of AAA, commented: “These two announcements are key milestones in AAA’s progress. The acquisition of the remaining 49.9% of Atreus has been triggered by a number of successful milestones achieved during the development of Annexin V-128. I am delighted that Atreus’ founder, Bill Dickie, will now be President and CEO of AAA Canada and will continue working with us in what we expect will be the development of products based on Annexin V. We are also very excited to be initiating the first of a series of new Phase I/II clinical trials aimed at understanding the potential of 99mTc-rhAnnexin V-128 in different indications.