Advanced Accelerator Applications Announces Health Canada Approval for Lutathera™, a Treatment for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Novartis successfully completes acquisition of Endocyte
Novartis today announced that it has completed the acquisition of Endocyte, Inc., a US-based biopharmaceutical company focused on developing radioligand and CAR-T therapies for cancer treatment.
Advanced Accelerator Applications signs exclusive option and license agreement with FUJIFILM Toyama Chemical to develop and commercialize radiolabeled FF-10158 for oncology indications
AAA today announced that it has entered into an exclusive option and license agreement with FUJIFILM Toyama Chemical, a leading radiopharmaceutical company in Japan, to develop and commercialize radiolabeled FF-10158 for oncology indications.
Novartis announces presentation of new Lutathera® NETTER-1 data at ESMO demonstrating significant improvement in PFS regardless of baseline liver tumor burden
Novartis today announced presentation of a new analysis of Lutathera® (lutetium Lu 177 dotatate*) NETTER-1 data at the 2018 European Society for Medical Oncology (ESMO) congress examining the impact of Lutathera treatment on patients with low, medium or high liver tumor burden.
Advanced Accelerator Applications Announces First Patients Dosed in Two Clinical Studies with PSMA-R2 for Prostate Cancer – Second Theragnostic Program for Oncology Enters the Clinic
AAA today announced that the first patients have been dosed in two Phase I/II clinical studies of radiolabeled PSMA-R2, a urea-based ligand of Prostate-Specific Membrane
Antigen (PSMA), which is commonly expressed on prostate cancer cells.
Novartis announces JCO publication of Lutathera® NETTER-1 data showing significantly longer time to deterioration of key quality of life measures in patients with progressive midgut NETs
Novartis today announced that the Journal of Clinical Oncology has published results of an analysis of the impact of Lutathera® (lutetium Lu 177 dotatate*) treatment on time to deterioration in HRQoL in the pivotal phase III NETTER-1 trial. The data demonstrate that treatment with Lutathera provides significantly longer time to deterioration of quality of life for patients with progressive midgut Neuroendocrine tumors (NETs) compared to octreotide LAR alone. Lutathera is the first Peptide Receptor Radioisotope Therapy (PRRT) to receive regulatory registration, with approval by the European Commission in September 2017 and by the US Food and Drug Administration (FDA) in January 2018. Lutathera is an Advanced Accelerator Applications product.
Advanced Accelerator Applications Signs Exclusive License Agreement with Cancer Targeted Technology to Develop CTT1057, an F-18 Labeled PSMA Ligand for Diagnostic Applications in Prostate Cancer
AAA today announced that it has entered into an exclusive worldwide license agreement with Cancer Targeted Technology, LLC (CTT) to develop and market an investigational new drug product, F-18-labeled CTT1057. CTT1057 is a ligand of Prostate-Specific Membrane Antigen (PSMA) for Positron Emission Tomography (PET) imaging of prostate cancer.
CTT has developed a phosphoramidate-based peptide, which specifically binds to PSMA. A Phase I study in 20 patients was conducted at the University of California, San Francisco. AAA will work to further develop and commercialize this diagnostic agent for prostate cancer. The terms of the agreement include an upfront licensing fee, as well as certain milestone and royalty payments.
Advanced Accelerator Applications Announces Completion of Subsequent Offering Period for Novartis Tender Offer
AAA, a Novartis company and a leader in nuclear medicine theragnostics, today announced that a subsidiary of Novartis AG (NYSE: NVS) (“Novartis”), Novartis Groupe France S.A. (“Purchaser”), has completed the subsequent offering period of the tender offer to purchase all of the outstanding ordinary shares (“Ordinary Shares”), including Ordinary Shares represented by American Depositary Shares (“ADSs”), of AAA for a price of USD 41.00 per Ordinary Share and USD 82.00 per ADS, in each case, payable net to the seller in cash, without interest (the “Offer”). The subsequent offering period for the Offer, which commenced on January 22, 2018, expired as scheduled at 12:00 midnight, New York City time, on January 31, 2018. According to Novartis, The Bank of New York Mellon, as ADS tender agent for the Offer, and Banque Transatlantique S.A., as Ordinary Shares agent for the Offer, have advised that, as of the expiration of the subsequent offering period, 95,127,753 Ordinary Shares (including Ordinary Shares represented by ADSs) were validly tendered during the initial offering period and the subsequent offering period taken together, representing approximately 98.7% of all outstanding Ordinary Shares (including Ordinary Shares represented by ADSs). Purchaser has accepted for payment and has promptly paid (or will promptly pay) for all Ordinary Shares and ADSs validly tendered during the subsequent offering period.
Advanced Accelerator Applications Receives US FDA Approval for LUTATHERA® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors
AAA today announced that it has received US Food and Drug Administration (FDA) approval of its new drug application (NDA) for LUTATHERA® (lutetium Lu 177 dotatate*) for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. LUTATHERA®, which received orphan drug designation from the FDA, is a first-in-class drug and the first available FDA-approved Peptide Receptor Radioisotope Therapy (PRRT), a form of targeted treatment comprising a targeting molecule that carries a radioactive component.