AAA today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

The Lutathera NDA is based on the results of a randomized pivotal Phase 3 study, NETTER-1 that compared treatment using Lutathera with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under Octreotide LAR treatment and overexpressing somatostatin receptors. 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% in disease progression or death versus a treatment with a double dose of Octreotide LAR. Efficacy and safety data from a large Phase I-II trial conducted in more than 1,200 patients in NET indications is also part of the NDA.

“We are encouraged that the FDA has granted Priority Review for Lutathera as a potential treatment for GEP-NETs,” said Stefano Buono, Chief Executive Officer of AAA. “We believe this action emphasizes the need to improve the lives of these patients.”

AAA announced that it has further strengthened its U.S. supply chain for NETSPOT(TM) with the addition of two radiopharmacy networks, Triad Isotopes, Inc., the second largest radiopharmaceutical company in the United States, and Nuclear Diagnostic Products, Inc. (“NDP”), a company with three radiopharmacies in the Northeast and a member of United Pharmacy Partners Inc. (“UPPI”), to supply gallium 68 (“Ga 68”) dotatate doses prepared with a novel kit to U.S. hospitals and imaging centers.

NETSPOT (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors (“NETs”) in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the FDA.

Triad and NDP will each prepare and deliver NETSPOT patient doses to advanced medical imaging sites in selected metropolitan areas. The addition of these partnerships completes the foundation of a robust nationwide supply chain that now includes four radiopharmacy networks.

Cardinal Health, Inc. (NYSE: CAH), a healthcare services company operating the largest radiopharmaceutical network in the United States, 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).

NETSPOT(TM) (formerly known as Somakit-TATE) is a patented kit recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of Ga 68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET“). The product has received orphan drug designation from the U.S. Food and Drug Administration (“FDA“).

Cardinal Health’s extensive U.S. network of radiopharmaceutical manufacturing facilities will prepare and deliver NETSPOT patient doses to advanced medical imaging sites in key metropolitan areas where high demand is anticipated. This partnership makes Cardinal Health the second radiopharmacy network that will participate in the NETSPOT supply chain, after the announcement of the Zevacor Pharma partnership earlier this year.

AAA today announced the expansion of its pipeline of theranostic products with the addition of NeoBOMB1, a novel GRPR antagonist, and that two abstracts presenting NeoBOMB1 data have been selected for oral presentations at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2016 Annual Meeting in San Diego, California. One of the two submissions was given the “International Best Abstract” Award.

These two independent studies evaluated NeoBOMB1 in a prostate cancer model, with both diagnostic and therapeutic isotopes, including an initial clinical evaluation performed in prostate cancer patients.

“We are broadening our pipeline with NeoBOMB1 by leveraging a formula that we have already successfully applied to develop our lead therapeutic candidate, Lutathera and diagnostic product, Somakit, which was recently approved by the US Food and Drug Administration. Our plan is to radiolabel NeoBOMB1 to develop a theranostic pair: 177Lu-NeoBOMB1 for treatment and a 68Ga-NeoBOMB1 for diagnosis. I believe NeoBOMB1 may have potential utility in PET diagnosis and as a targeted therapy in GRPR-expressing malignancies,” said Stefano Buono, Chief Executive Officer of AAA.

NeoBOMB1 was originally developed by Marion De Jong of Erasmus University Medical Center and Theodosia Maina and Berthold Nock of Demokritos. AAA has acquired the rights to develop NeoBOMB1 and is currently planning three clinical studies in different indications including gastrointestinal stromal tumors, prostate cancer and breast cancer.

AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. NETSPOT received approval following a Priority Review from the FDA.

NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. NETSPOT is the first approved drug using Ga 68 as a positron emitter. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.

Following today’s approval, NETSPOT will be made available to the US market as soon as possible. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas.

NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler.

“The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA. “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.”

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.”