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.

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.

Advanced Accelerator Applications Announces $3.9 Billion All Cash Proposed Tender Offer by Novartis

AAA today announced that it has entered into a Memorandum of Understanding with Novartis, pursuant to which Novartis proposes to make a cash tender offer to acquire all the outstanding shares of AAA, including shares represented by American Depositary Shares (the “ADSs”), for $41 per ordinary share and $82 per ADS (each representing 2 ordinary shares), in a transaction that is valued at approximately $3.9 billion.

Advanced Accelerator Applications Announces European Approval of Lutetium (177Lu) Oxodotreotide (Lutathera®) for Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors – Completes First Theragnostic Radiopharmaceutical Pairing in Oncology

AAA today announced that the European Commission (EC) has approved 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.” This approval allows for the marketing of lutetium (177Lu) oxodotreotide (Lutathera®) in all 28 European Union member states, as well as Iceland, Norway and Liechtenstein.

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