Print Page     Close Window     

SEC Filings

ADVANCED ACCELERATOR APPLICATIONS S.A. filed this Form SC14D9C on 11/17/2017
Entire Document

Exhibit 99.1





 Advanced Accelerator Applications Reports 39% Sales Growth for Third Quarter 2017


$3.9 Billion All Cash Proposed Tender Offer by Novartis


European Approval of Lutetium Lu 177 Dotatate* (Lutathera®) for GEP-NETs


Recent Highlights:


·Sales for the third quarter of 2017 increased 39% compared to the third quarter of 2016


·NETSPOT® unit sales per month increased 14% (from 915 to 1040) from June to September 2017


·Entered into a Memorandum of Understanding with Novartis, pursuant to which Novartis proposes to make a $3.9 billion cash tender offer to acquire all the outstanding shares of AAA


·European Commission approved marketing authorization for lutetium Lu 177 dotatate* (Lutathera®) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults


·Received Prescription Drug User Fee Act (PDUFA) action date of January 26, 2018 for lutetium Lu 177 dotatate* (Lutathera®) New Drug Application (NDA) to the US Food and Drug Administration (FDA)


·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


·FDA allowed production of EAP doses at Millburn, New Jersey site


·226 patients and 30 centers in the US, and 1,857 patients and 67 centers in Europe were participating in the lutetium Lu 177 dotatate* (Lutathera®) Expanded Access, compassionate use and named patient programs at October 31, 2017


November 17, 2017, Saint-Genis-Pouilly, France - Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), a leader in nuclear medicine theragnostics, today announced its financial results for the third quarter ended September 30, 2017.


Stefano Buono, Chief Executive Officer of AAA, commented, “The last few months have been truly transformative for AAA. With European Commission’s approval of the marketing authorization for lutetium Lu 177 dotatate* (Lutathera®), and the continued growth of NETSPOT® and SomaKit TOC®, we have achieved our vision of becoming the first radiopharmaceutical theragnostics platform in the global oncology marketplace. We are progressing with the commercial launch of lutetium Lu 177 dotatate* (Lutathera®) in Europe, and are approaching the FDA PDUFA action date. The Novartis tender offer adds to this momentum, and we believe the proposed transaction will strategically position us to further accelerate development of our other theragnostic pipeline assets and maximize the impact of our platform on the oncology market.”



© -20 Advanced Accelerator Applications - All rights reserved .