News

July 27, 2017

Advanced Accelerator Applications Completes Resubmission of NDA for Lutetium Lu 177 Dotatate (Lutathera®) to FDA

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.

July 21, 2017

Advanced Accelerator Applications Announces Positive CHMP Opinion Recommending Approval of Lutetium 177Lu Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors

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.

May 30, 2017

Advanced Accelerator Applications and Blue Earth Diagnostics Announce European Manufacturing and Distribution Agreements for Axumin™ (Fluciclovine (18F)) for PET Imaging of Recurrent Prostate Cancer

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.

May 25, 2017

Advanced Accelerator Applications Appoints Christine Mikail to Board of Directors

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

May 18, 2017

Advanced Accelerator Applications Receives 2017 Industry Innovation Award from National Organization for Rare Disorders for NETSPOT®, a Diagnostic Drug for Neuroendocrine Tumors

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.

March 30, 2017

Advanced Accelerator Applications Signs Strategic Supply Agreement with University of Missouri for Lutetium 177

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.

March 23, 2017

Advanced Accelerator Applications Reports 23% Sales Growth for Fiscal 2016; Continued NETSPOT® Launch Success

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.

March 15, 2017

Advanced Accelerator Applications to Announce Full-Year 2016 Financial Results on March 23

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.

March 6, 2017

Advanced Accelerator Applications Announces Presentation of Quality of Life Findings from NETTER-1 Phase III Study at ENETS

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

March 1, 2017

Advanced Accelerator Applications Announces Addition of NETSPOT® to National Comprehensive Cancer Network® Guidelines for Evaluation of NETs

AAA today announced that its product NETSPOT® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). NCCN® is a not-for-profit alliance of leading cancer centers in the U.S. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care.

NETSPOT® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. AAA and its radiopharmacy partners around the U.S. are now delivering 400 doses of NETSPOT® per month. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017.

January 12, 2017

Advanced Accelerator Applications Announces New England Journal of Medicine Publication of NETTER-1 Phase III Results

AAA today announced that the New England Journal of Medicine published the results of the NETTER-1 Phase III study evaluating 177Lutetium Dotatate, an investigational drug, in patients with advanced, progressive somatostatin receptor-positive midgut neuroendocrine tumors (“NETs”).

January 4, 2017

Advanced Accelerator Applications to Present at 35th Annual J.P. Morgan Healthcare Conference

AAA today announced that the company is scheduled to present at the 35th Annual J.P. Morgan Healthcare Conference, January 9-12, 2017, in San Francisco, CA.

Stefano Buono, Chief Executive Officer; Gerard Ber, Chief Operating Officer; and Heinz Mäusli, Chief Financial Officer will present on Wednesday, January 11, 2017 at 11:30 a.m. PST.

A live and archived webcast of the Company’s presentation will be available on the Investor Relations page.