ITEL signs agreement with AAA to commercialize F-18 radiopharmaceuticals in Southern Italy

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 reports 26.8% sales growth in 2015 and continues to show significant clinical progress across both therapeutic and diagnostic platforms – Company announces completed submission of Lutathera NDA and MAA to FDA and EMA respectively

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.”

Advanced Accelerator Applications to Announce Fourth Quarter and Year End 2015 Financial Results on April 29, 2016

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 Opens Lutathera Expanded Access Program In U.S. to Eligible Patients And Announces Forthcoming NDA Filing to FDA and EMA

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 to produce SomaKit-TATE doses for AAA – Novel kit for the preparation of Ga-68 DOTATATE for neuroendocrine tumor detection

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.

Advanced Accelerator Applications to Announce Third Quarter and Nine-Month 2016 Financial Results on November 28

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.

Advanced Accelerator Applications to Present New Data from Lutathera NETTER-1 Phase 3 Study at 2016 Gastrointestinal Cancer Symposium (ASCO GI)

AAA today announced that new safety and efficacy data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) will be presented on Friday, January 22, 2016 at the 2016 Gastrointestinal Cancer Symposium ASCO GI in San Francisco, California.

The NETTER-1 abstract has also been selected for ASCO GI’s official Press Program and the new findings of the NETTER-1 study will be presented to journalists in a presscast on Tuesday, January 19, 2016 from 12:00-1:30 PM ET.

Advanced Accelerator Applications 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

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.

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.