AAA today announced that following a positive opinion issued by the European Medicines Agency in October 2016, the European Commission has approved SomaKit TOC™ 40 μg, 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 (GEPNETs) for localizing primary tumors and their metastases. The drug has 10-year orphan market exclusivity in the European territory.

AAA today announced that the Centers for Medicare & Medicaid Services (CMS) has granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers.

A first-in-class drug, NETSPOT® was approved after a record-breaking 23 months from the first pre-Investigational New Drug meeting with the FDA. The product has been used and paid for over the past six months, even prior to the issuance of this Pass-Through code, demonstrating recognition of NETSPOT’s® value to NET patient management.

Stefano Buono, Chief Executive Officer of AAA said, “The enthusiastic response of the NET patient and physician community to NETSPOT® has been remarkable. Once effective, this coding will streamline billing and reimbursement for all institutions using the product. The NETSPOT® rollout is progressing in line with our expectations and recent changes in the Nuclear Regulatory Commission guidelines should facilitate placement of additional gallium Ga 68 generators around the country.”

AAA today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

Third Quarter Highlights:

– Sales for the third quarter of 2016 increased 15.4% compared to the third quarter of 2015
– Closed $150 million follow-on public offering and subsequent underwriters option to purchase additional $22.5 million
– The U.S. Food and Drug Administration (FDA) issued feedback via a Discipline Review Letter on the New Drug Application (NDA) for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
– The European Medicines Agency (EMA) issued a positive opinion on the Marketing Authorization Application for SomaKit TOC
– Achieved marketing authorization in Switzerland for DOPAVIEW and AAACholine
– Initiated two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin) in cardiovascular and cardio-oncology indications

AAA announced today that the company has been granted marketing authorization in Switzerland for two Positron Emission Tomography (PET) products, DOPAVIEW and AAACholine.

DOPAVIEW is AAA’s brand name for 6-fluoro-(18F)-L-DOPA, a DOPA analogue. DOPA is an aromatic amino acid that accumulates rapidly in target tissues of the human brain and is transformed into dopamine, a neurotransmitter. In neurology, PET imaging with DOPAVIEW is indicated for diagnosis of Parkinson’s disease and differentiation between essential tremor and parkinsonian syndromes. In oncology, PET imaging with DOPAVIEW enables diagnosis, localization and characterization of various tumor types, such as neuroendocrine tumors, gliomas, and thyroid cancer.

DOPAVIEW will benefit from a 10-year marketing exclusivity, since AAA is the first company to obtain marketing authorization for this product in Switzerland.

AAACholine is AAA’s brand name for 18F-choline. 18F-choline is indicated for PET imaging in prostate cancer patients, including localization of lesions, characterization of the tumor in case of biochemical relapse and evaluation of the response and follow-up of patients with loco/regional and/or metastatic recurrence.

AAA today announced that the European Medicines Agency (EMA) has issued a positive opinion on the Marketing Authorization Application for SomaKit TOC 40 µg, 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. Once marketing authorization is granted, SomaKit TOC will benefit from 10-year orphan market exclusivity in the European territory.

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.”