AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40µg, a kit for radiopharmaceutical preparation of gallium (Ga 68) edotreotide solution for injection, for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET) for localizing primary tumors and their metastases. The European Commission (EC) decision regarding granting of marketing authorization in all EU countries is expected in the coming months.

Following approval by the EC, SomaKit TOC will be made available to the European market as soon as possible. In most European countries, SomaKit TOC will be available as a unique kit for reconstitution, including two vials and a cartridge for direct elution using a gallium Ga 68 generator.

“We are excited to have achieved a positive EMA opinion on our SomaKit TOC application,” said Stefano Buono, Chief Executive Officer of AAA. “This milestone comes soon after U.S. Food and Drug Administration (FDA) approval of NETSPOT™ (gallium Ga 68 dotatate) in June. We believe our diagnostic products offer NET patients superior accuracy and specificity compared to previously available diagnostic products, while reducing patient burden.”

“AAA is committed to bringing innovation to NET patients,” added Buono. “Between NETSPOT™, SomaKit TOC, and our therapeutic product, Lutathera, our team has simultaneously managed four major regulatory submissions to the FDA and EMA for this indication over the course of this year.«

AAA today announced the initiation of two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin), a single-photon emission computed tomography (SPECT) diagnostic candidate for the assessment of apoptosis and necrosis, forms of cell death in cardiovascular and cardio-oncology indications at the University of Ottawa Heart Institute and The Ottawa Hospital.

Stefano Buono, Chief Executive Officer of AAA said, “Having diagnostic tools that can accurately detect apoptosis and necrosis in cardiovascular settings can facilitate early diagnosis of potentially life-threatening conditions, enable more precise risk stratification, and help physicians monitor the efficacy and safety of treatments in individual patients during the course of therapy. Our goal is to develop Annexin into a personalized disease management tool for multiple inflammatory diseases.”

AAA today announced the first administration of NETSPOT, a product recently approved by the U.S. Food and Drug Administration (“FDA”) for the preparation of gallium 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“) at Holy Name Medical Center (“Holy Name”) in Teaneck, NJ.

Stefano Buono, Chief Executive Officer of AAA said, “We are very excited to bring NETSPOT, a widely anticipated new imaging product to patients in the U.S. We believe NETSPOT offers superior sensitivity and accuracy compared to previously available diagnostics for NET patients. In a clinical study, NETSPOT demonstrated the ability to change management decisions regarding patients in 71% of cases previously imaged with Octreoscan.1 Saving just one patient from futile surgery can improve the treatment experience, as well as generate cost savings greater than the cost of providing a year’s worth of NETSPOT injections to every NET patient treated in the same hospital! We are proud to contribute to the introduction of pharmaceutical products that improve patient care, while decreasing healthcare costs.”

NETSPOT is currently available in the U.S. 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. AAA has partnered with four radiopharmacies in the U.S. to facilitate availability of NETSPOT nationally, including Zevacor Pharma Inc., that delivered the NETSPOT injection to Holy Name Medical Center.

AAA today announced a clinical trial agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, whereby NCI will sponsor and conduct a study of Lutathera, an investigational drug, in patients with inoperable pheochromocytoma and paraganglioma.

Frank Lin, M.D., Medical Officer with the NCI’s Cancer Imaging Program and collaborator with the Molecular Imaging Program, directed by Peter Choyke, M.D., F.A.C.R., in NCI’s Center for Cancer Research will be the Principal Investigator for a planned NCI-sponsored study. The envisioned trial will draw from the unique population of pheochromocytoma and paraganglioma patients being evaluated at the NIH.

“We applaud the NCI’s efforts to address the needs of patients suffering from these rare malignancies and are pleased to facilitate the exploration of additional potential indications for Lutathera,” said Stefano Buono, Chief Executive Officer of AAA. “Over the past three years, Lutathera has been used under compassionate use and named patient programs in 10 European countries in almost 1,300 patients, including those with pheochromocytoma and paraganglioma. In a Phase II trial conducted at the Erasmus Medical Center that is part of our New Drug Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency, 45 patients with these indications were treated with a median Progression Free Survival of 24.8 months and a median Overall Survival that was not reached. We hope these results will be confirmed by the NCI trial.”

AAA today announced the opening of its first U.S. manufacturing facility in Millburn, NJ.

The 15,000 square foot facility features 12 production lines dedicated to Lutathera, as well as storage and office space. The site is conveniently located near Newark airport, enabling future delivery of Lutathera directly to hospitals and treatment centers around the country. There are currently more than 15 pharmaceutical manufacturing, sales and marketing, and administrative employees working on site, with plans to expand to 50 people.

In addition, the Millburn plant serves as a distribution center for NETSPOT™, a AAA product recently approved by the U.S. Food and Drug Administration for the preparation of Gallium Ga 68 dotatate for injection, a first in class drug for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET”). Oxygen-18 enriched water, an important precursor for the production of fluorodeoxyglucose used in PET, is also distributed by the new facility on behalf of Marshall Isotopes, a AAA company.

“We are excited to have our first U.S. manufacturing facility operational in preparation for the anticipated approval and launch of Lutathera,” said Stefano Buono, Chief Executive Officer of AAA. “The Millburn plant is our 22nd manufacturing site globally and we believe this facility will provide us with sufficient capacity to meet future demand for Lutathera in the North American market and manage distribution of our new generation of PET products.”

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.”