Advanced Accelerator Applications Announces First Patient in Bridging Study in Japan for Lutetium Lu 177 Dotatate (Lutathera®)

AAA today announced that the first patient has been treated in a Phase I clinical study of lutetium Lu 177 dotatate* in patients with inoperable, somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary neuroendocrine tumors (NETs) in Japan. The primary objective of this open-label, uncontrolled, single-center, bridging study is to evaluate the safety, tolerability, pharmacokinetics, and dosimetry of lutetium Lu 177 dotatate in Japanese patients. Six subjects will be included in the Phase I study.

Advanced Accelerator Applications Reports 32 % Sales Growth for Second Quarter 2017

Second Quarter 2017 Highlights:
• Sales for the second quarter of 2017 increased 32% compared to the second quarter of 2016
• NETSPOT® unit sales per month increased 63% (from 562 to 915) from March to June 2017
• Received positive opinion for lutetium Lu 177 dotatate* (Lutathera®) for the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
• Completed resubmission of lutetium Lu 177 dotatate* (Lutathera®) New Drug Application (NDA) to the US Food and Drug Administration (FDA) and received Prescription Drug User Fee Act (PDUFA) date of January 26, 2018
• FDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for lutetium Lu 177 dotatate* (Lutathera®) expanding enrollment to patients with progressive, advanced, inoperable NETs arising at all sites
• 140 patients and 23 centers in the US and 1,800 patients and 62 centers in Europe were participating in the lutetium Lu 177 dotatate* (Lutathera®) Expanded Access and compassionate use and named patient programs at July 31, 2017

Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) date of January 26, 2018, for Lutetium Lu 177 Dotatate (Lutathera®)

AAA today announced that the US Food and Drug Administration (FDA) has acknowledged receipt and considered complete the resubmission of the New Drug Application (NDA) for investigational drug lutetium Lu 177 dotatate* (Lutathera®). The Agency provided a new Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

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.

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.

Advanced Accelerator Applications Reports 21% Sales Growth for First Quarter 2017

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

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.

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.

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.

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.