AAA today announced its financial results for the first quarter of 2016. Commenting on the first quarter performance, Stefano Buono, AAA’s CEO, said, “Our continued sales momentum provides a strong foundation for the commercial launches of both Somakit and Lutathera, as well as the expansion of our theragnostic franchise as a whole.” Mr. Buono continued, “We are committed to continuing to deliver improved outcomes for patients with unmet medical needs through our specialized expertise in the development and production of molecular nuclear medicines, and the accomplishments of this past quarter underscore the progress we are making to that end.”

First Quarter Highlights:

– Sales for the first quarter of 2016 increased 29.6% compared to the first quarter of 2015
– Purchased 100% of the IDB Group to strengthen AAA’s commercial positioning of Lutathera
– Entered into a non-exclusive agreement with Zevacor for the preparation and delivery of SomaKit-TATE in the US
– Signed an exclusive licensing agreement with Johns Hopkins University to develop and market PSMA receptor ligand in prostate cancer for clinical therapeutic and diagnostic purposes

AAA announced today that AAA Germany GmbH has signed an asset purchase agreement to operate two new F-18 radiopharmaceutical production sites in South Germany. The transaction will close by June 1, 2016.

The first site, located in Erlangen, will be wholly owned and operated by AAA. The second site, located in Munich, will remain the property of the University Hospital of Munich (Klinikum der Universität München or KUM), with AAA responsible for production and commercialization onsite. The Munich contract includes a long-term F-18 in-house supply agreement with the KUM. Of particular value to AAA are the strong R&D activities of the KUM in radiotherapy with prostate specific membrane antigen (PSMA) and Lutetium.

“Advanced Accelerator Applications is very active in the European F-18 PET market with production facilities based in France, Germany, Italy, Poland, Portugal and Spain,” noted Stefano Buono, Chief Executive Officer of AAA. “With the addition of these two new productions sites to the one AAA is already operating in Bonn, the Company will now have three production sites in Germany and a total of 15 PET production sites in Europe. This acquisition is in line with our strategy to continue consolidating the European PET market and expand our geographical reach.”

Gérard Ber, Chief Operating Officer of AAA added: “Acquiring these two production sites in Germany will expand AAA’s presence in Germany and enable us to cover a very significant part of the German market. With this transaction AAA will become a market leader in Germany.”

AAA today announced that François Nader, M.D., MBA has joined the Company Board of Directors as an Independent Non-Executive Director.

«Dr. Nader’s guidance and perspective on global clinical development, regulatory, and commercial strategy will be of tremendous benefit as we advance our pipeline of product candidates led by Lu-DOTATATE (Lutathera®) for the treatment of Neuro Endocrine Tumors, a significant unmet medical need,“ stated Stefano Buono, Chief Executive Officer of AAA. “Dr. Nader’s deep biopharmaceutical expertise, coupled with his experience in orphan drug product launches, will be extremely valuable to help guide AAA in its mission to become a leading global player in Molecular Nuclear Medicine.»

“I am delighted to join AAA’s Board of Directors. I believe that radiopharmaceuticals could represent a transformative new modality in cancer therapeutics, and I look forward to contributing to the company’s growth and success,» said François Nader, M.D.

Dr. Nader will be replacing Muriel de Szilbereky, who served as a Director in exemplary fashion from June 2013. The AAA Board will continue to be chaired by Claudio Costamagna, and will consist of eight Directors in total – 7 of which are independent.

AAA today announced that it is scaling up its Ivrea site for Lutathera production. AAA has recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead Neuro Endocrine Tumor therapeutic candidate Lutathera. The EMA has recently granted Accelerated Assessment for Lutathera. The Ivrea extension is in anticipation of the NDA and MAA approvals.

The AAA Ivrea site hosts the Headquarters of AAA Italy and is located in the Bioindustry Park Silvano Fumero, between Turin and Milan. AAA started commercial operations on this site in 2008. Since then the site has almost doubled in size and increased headcount by 46 employees. The site currently covers 640sqm of laboratories and 530sqm of office space and employs 52 people.

“The AAA Ivrea site is one of Lutathera’s birth places. It is in Ivrea that Lutathera was developed from a radiochemical point of view,” said Stefano Buono, Chief Executive Officer of AAA. “As we ramp up for the Lutathera launch we are putting all of the pieces in place to ensure seamless production and distribution of Lutathera in Europe and in the US. The extension of the AAA Ivrea site is essential to achieve these objectives.”

“We are proud to have such an active company in the Bioindustry Park Silvano Fumero. We have helped AAA in its journey and are happy to see that eight years after its arrival the Company is still here and growing”, said Fabrizio Conicella, Director of the Bioindustry Park Silvano Fumero.

ITEL has signed an agreement with Advanced Accelerator Applications to manufacture and commercialise F-18 radiopharmaceuticals to hospitals and imaging centers in selected regions of Southern Italy.

Following AIFA authorisation, ITEL will manufacture F-18 radiopharmaceuticals under AAA license in its production plant in Ruvo di Puglia (BA) and commercialise them across the PET centers located in select regions of Southern Italy. AAA’s key F-18 product is Gluscan®, its branded fluorodeoxyglucose (FDG) PET imaging agent which assists in the diagnosis of serious diseases, primarily in oncology, by assessing glucose metabolism.

“AAA is very active in the European F-18 PET market with 13 PET production facilities based in France, Germany, Italy, Poland, Portugal and Spain”, noted Stefano Buono, Chief Executive Officer of AAA. “This agreement will reinforce AAA’s position as one of the leading companies in the F-18 PET market in Italy.”

Advanced Accelerator Applications today announced its Q4 and full year 2015 financial results. The company reported an increase in year-on-year sales of 26.8% for the full-year and a 14% increase for Q4 2015 compared to Q4 2014. For the year ended 31 December 2015 total sales were €88.6 million (+26.8% vs. 2014).

Other key news announced is that the company had completed its rolling NDA submission to the FDA and that it had also recently submitted a Lutathera MAA to the EMA. In these filings AAA has asked for priority review to the FDA and Accelerated Assessment to the EMA.

Mr. Stefano Buono, AAA’s CEO, commented, “2015 was a pivotal year for AAA. We continued our trend of significant sales growth, and the year was marked by the completion of two key milestones, namely: the completion of our IPO and simultaneous listing on the Nasdaq under the ticker “AAAP” and the announcement of favourable results from the pivotal Phase 3 NETTER-1 trial evaluating our lead therapeutic candidate, Lutathera. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera.”

Mr. Buono concluded, “In 2016, we have already achieved several key milestones to advance the company forward and support our future success. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in both the US and Europe, we look forward to reporting our commercial developments gearing up towards the launch of both products.”

AAA today announced that the company will provide an update on corporate activities for the fourth quarter and year-end 2015 on April 29, 2016. A press release for the fourth quarter and year-end 2015 will be released prior to the call.

Stefano Buono, Chief Executive Officer, Heinz Mäusli, Chief Financial Officer and Gérard Ber, Chief Operating Officer, will conduct a conference call at 11:00 am ET that day to provide a business update and review the Company’s fourth quarter and year-end 2015 financial results.

To access the conference call, please connect to the following webcast URL http://edge.mediaserver.com/m/p/9ucv3sgh/lan/en or dial 877-751-5015 from the U.S., or + 1-615-247-0178 internationally and use the audience passcode 96896214.

A recording of the conference call will be archived on the «Investors» section of the AAA website.

AAA today announced that the company has initiated an expanded access program (EAP) in the United States for the investigational product, Lutathera. Through the program, Lutathera is being made available for patients suffering from inoperable, somatostatin receptor positive, midgut carcinoid tumors, progressive under somatostatin analogue therapy. Healthcare professionals and patients can learn more about the Lutathera EAP by visiting www.clinicaltrials.gov (trial number: NCT02705313).

Today AAA also announced a New Drug Application (NDA) filing plan for Lutathera, following the pre-NDA meeting held on the 14 March 2016. Given that rolling submissions are possible under the Fast-Track program granted for Lutathera, the Agency accepted a submission plan in which all parts of the NDA are to be sent by the end of the current month except for the ISS and ISE (Integrated Summaries of Safety and Efficacy Databases) which should be submitted within thirty days after the bulk of the submission.

The review clock for the NDA will not begin until AAA informs the FDA that a complete NDA has been submitted, including the ISS and ISE. The rolling submission will, however, allow the FDA to immediately start the review of the most relevant parts of the application, including the separate Clinical Reports of both NETTER-1 and the Phase 2 study.

Given the fact that rolling submissions are not permitted at the European Medicine Agency (EMA), a complete submission to the EMA will be completed by the end of April.

Zevacor Pharma, Inc. (fka “IBA Molecular North America, Inc.”), a leader in the manufacture and distribution of radiopharmaceuticals, announced that it has been selected to supply Gallium 68 (Ga-68) DOTATATE doses prepared with a novel kit to U.S. hospitals and imaging centers for Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA”). SomaKit-TATE is a patented kit currently in development for the preparation of 68Ga-DOTATATE for injection, to help diagnose and manage somatostatin receptor-positive neuroendocrine tumor patients using Positron Emission Tomography (“PET“). The kit has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“). The FDA has also granted Priority Review to AAA’s New Drug Application (“NDA”) for the kit. The license application for the kit is currently under review by the FDA and the agreement between Zevacor and AAA is in anticipation of NDA approval.

Zevacor’s U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver SomaKit-TATE patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated.

AAA today announced that the company will report its financial results for the third quarter and nine-month period ended September 30, 2016, on November 28.

Stefano Buono, Chief Executive Officer and Heinz Mausli, Chief Financial Officer will host a conference call at 4:30 p.m. ET to review the quarter and discuss business updates.

Interested parties may participate by dialing 877-407-8133 (US) or +1-201-689-8040 (International), approximately five minutes before the call start time. A live webcast of the conference call will be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175484.