AAA today announced that the resubmission of the New Drug Application (NDA) for investigational drug lutetium Lu 177 dotatate* (Lutathera®) to the US Food and Drug Administration (FDA) was completed. AAA resubmitted the NDA following receipt of a complete response letter (CRL) from the FDA in December 2016, in which the Agency cited issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which precluded FDA reviewers from performing the required independent analysis of these clinical studies.

The company also announced that the FDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for lutetium Lu 177 dotatate (Lutathera®) to permit enrollment of patients with metastasized or locally advanced, inoperable neuroendocrine tumors (NETs) arising at all sites (including foregut, midgut and hindgut), and that have progressive disease during or after treatment with somatostatin analogues. In addition, the amendment includes the use of a 2.5% lysine/arginine amino acid solution as an additional option for renal protection.

AAA today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization of lutetium (177Lu) oxodotreotide* (Lutathera®) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The European Commission (EC), which has the authority to approve medicines for the European Union, Iceland, Norway and Liechtenstein will review the CHMP recommendation.

AAA today announced its financial results for the first quarter ended March 31, 2017.
First Quarter 2017 Highlights:
– Sales for the first quarter of 2017 increased 21% compared to the first quarter of 2016
– NETSPOT® unit sales per month increased 140% (from 232 to 559) between December 2016 and March 2017

AAA and Blue Earth Diagnostics Ltd., a molecular imaging diagnostics company, today announced that they have entered into a non-exclusive manufacturing agreement and an exclusive distribution agreement for the supply of Blue Earth Diagnostics’ PET imaging product Axumin™ (fluciclovine (18F)) in France, Germany, Spain, Italy, and Portugal. Axumin is indicated in Europe for use in Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.

AAA today announced that Christine Mikail, J.D. has joined the Company’s board of directors as an independent non-executive director.

AAA today announced that it will receive a 2017 Industry Innovation Award from the National Organization for Rare Disorders (NORD®) for NETSPOT® (gallium Ga 68 dotatate), a diagnostic drug for the localization of neuroendocrine tumors (NETs) using a positron emission tomography (PET) scan, at the NORD Rare Impact Awards ceremony taking place in Washington, D.C. this evening. NORD is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them. Each year, NORD’s Rare Impact Awards program recognizes individuals and organizations that have made a positive impact on patients’ lives.

AAA today announced a 10-year exclusive supply agreement for lutetium 177 with the University of Missouri Research Reactor (MURR®). Through this agreement, MURR® will supply AAA with GMP-quality lutetium 177 Chloride, the precursor for production of investigational product lutetium Lu 177 dotatate (Lutathera®) and other Lu 177-based therapeutics in development.

AAA today announced its financial results for fiscal 2016. On Track to Resubmit NDA for lutetium Lu 177 dotatate (Lutathera®) to FDA in Mid-2017.

AAA today announced that the Company will report its financial results for the fiscal year ended December 31, 2016, on March 23.

Stefano Buono, Chief Executive Officer and Heinz Mäusli, Chief Financial Officer will host a conference call at 10:00 a.m. ET to review the financial results 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=175722.

AAA today announced that quality of life findings from the pivotal NETTER-1 Phase III study investigating the treatment of Lutetium Lu 177 Dotatate in patients with somatostatin receptor positive midgut neuroendocrine tumors (midgut NETs) will be presented at the 14th Annual Conference of the European Neuroendocrine Tumor Society (ENETS), March 8-10 in Barcelona, Spain.

The details of the presentations are as follows:
Abstract # 1676: NETTER-1 Phase III Trial: Recent Findings on Quality of Life in Patients with Midgut Neuroendocrine Tumors
Session Date: March 9, 2017
Session Time: 14:15-14:25 Central European Time