AAA today announced that data from the pivotal NETTER-1 Phase III study investigating the treatment of Lutathera® (lutetium Lu 177 dotatate) in patients with somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) and preclinical oncology studies with NeoBOMB1, a novel GRPR antagonist, will be presented at the 29th Annual Congress of the European Association of Nuclear Medicine (EANM), October 15-19, in Barcelona, Spain.

AAA today announced the pricing of an underwritten public offering of 3,947,369 American Depositary Shares (“ADSs”) representing ordinary shares of the Company at a public offering price of $38.00 per ADS, before underwriting discounts and offering expenses. The gross proceeds from the sale of the ADSs, before underwriting discounts and commissions and offering expenses, are expected to be approximately $150 million. In addition, the underwriters have a 30-day option to purchase up to an additional 592,104 ADSs on the same terms and conditions.

AAA today announced that it has commenced an underwritten public offering of $125 million of American Depositary Shares (“ADSs”) representing ordinary shares of the Company. All ADSs will be offered by AAA. In addition, AAA expects to grant the underwriters a 30-day option to purchase up to $18,750,000 of additional ADSs at the public offering price, less the underwriting discount.

AAA announced today that the European Medicines Agency (EMA) prematurely notified the public and the company of its opinion on the Marketing Authorization Application for SomaKit TOC®, 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 EMA posted the following statement on its website: “The adoption of the CHMP opinion for SomaKit TOC was included in the CHMP highlights in error. This opinion has now been removed from the highlights as this procedure is still ongoing. Once the procedure is finalised, EMA will communicate its outcome.”

SomaKit TOC® is composed of both a medicinal product and a device component. Finalization of the opinion on the kit is subject to the device component being certified by the relevant notified body. This requirement should have no impact on the benefit-risk assessment of the product. Once it has been fulfilled, the EMA will issue its final opinion on SomaKit TOC®.

“We are actively collaborating with the EMA staff to move forward as quickly as possible,” said Stefano Buono, Chief Executive Officer of AAA.

AAA today announced that the Accelerated Assessment timeline for the European Medicines Agency (EMA) review of the Marketing Authorization Application (MAA) for Lutathera®, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of neuroendocrine tumors (NETs), has been modified to a standard review period due to additional clarifications requested by the EMA, as well as their request to inspect one of AAA’s contract research organizations (CRO).

“Our team is working closely with EMA reviewers to facilitate this process,” said Stefano Buono, Chief Executive Officer of AAA. “While the time required to address these requests and conduct the work with the involved CRO will prevent the achievement of the original Accelerated Assessment timeline, the EMA’s revised approval timeline continues to be in line with what we have anticipated for our commercial planning in Europe. I am pleased to share that in the last month, the U.S. Food and Drug Administration has successfully completed inspections of both of our CROs, several clinical sites and all of our manufacturing sites.”

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 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.”