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 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