Advanced Accelerator Applications Announces Start of Phase III Study Investigating Radioligand Therapy Lutathera® as First-Line Treatment in Patients with Advanced GEP-NETs
Advanced Accelerator Applications Announces State of Israel Ministry of Health Approval for Lutathera®, in the Treatment of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Advanced Accelerator Applications Receives Positive CHMP Opinion for LysaKare® for Reduction of Kidney Exposure to Radiation During Peptide Receptor Radionuclide Therapy with Lutetium (177Lu) Oxodotreotide (Lutathera®)
Advanced Accelerator Applications Announces Health Canada Approval for Lutathera™, a Treatment for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
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.
Advanced Accelerator Applications Announces Completion of $3.9 Billion Novartis Tender Offer Novartis Global Oncology Expertise to Enhance Launch of Lutetium Lu 177 Dotatate (LUTATHERA®) and Accelerate Development of Theragnostic Pipeline.
Advanced Accelerator Applications Announces Commencement of Novartis Tender Offer
AAA today announced that a direct and indirect subsidiary of Novartis AG (NYSE: NVS), Novartis Groupe France S.A., a société anonyme organized under the laws of France (“Purchaser”), has commenced a cash tender offer to purchase all of the outstanding ordinary shares, nominal value €0.10 per share (each, an “Ordinary Share,” and collectively, the “Ordinary Shares”), including Ordinary Shares represented by American Depositary Shares (each of which represents two Ordinary Shares) (each, an “ADS,” and collectively, the “ADSs,” and, together with the Ordinary Shares, the “Company Shares”), of AAA, for a price of US $41.00 per Ordinary Share and US $82.00 per ADS, in each case, payable net to the seller thereof in cash, without interest, less any withholding taxes that may be applicable (the “Offer”). The Offer is being made upon the terms and subject to the conditions set forth in the Offer to Purchase, dated December 7, 2017 (the “Offer to Purchase”), the accompanying Ordinary Share Acceptance Form and ADS Letter of Transmittal, and pursuant to the terms of the previously announced Memorandum of Understanding, dated as of October 28, 2017, by and between Novartis and AAA, as amended on December 5, 2017 (the “MoU”).
Advanced Accelerator Applications Board of Directors Recommends $3.9 Billion All Cash Tender Offer by Novartis
AAA today announced that its Board of Directors, following the completion of the information and consultation of the Company’s works council, has (i) determined that the transactions contemplated in the Memorandum of Understanding entered into with Novartis AG (NYSE: NVS) on October 28, 2017, including the cash tender offer described in the subsequent paragraph, are (x) consistent with and will further the business objectives and goals of the Company, (y) advisable and (z) in the best interests of the Company, its stockholders, other stakeholders and its employees, (ii) approved and adopted the transactions contemplated by the MoU and (iii) determined to recommend that the Company’s stockholders support the offer, accept the offer and tender their shares in the offer.
Advanced Accelerator Applications Reports 39% Sales Growth for Third Quarter 2017
AAA today announced its financial results for the third quarter ended September 30, 2017. Total sales for the third quarter of 2017 were €37.2 million (US$43.9 million), a 39% increase compared to €26.7 million (US$31.5 million) in the third quarter of 2016.