The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018. Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 'With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.'

'Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,' said Bruno Strigini, CEO, Novartis Oncology. The transaction would strengthen Novartis' oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs. Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera ( 177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumors (NETs). Novartis announced recently, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications would bring to Novartis an expanded pipeline of RLT programs with significant sales potential, including 177Lu-PSMA-R2 entering Phase 1/2 for prostate cancer.Integration of Advanced Accelerator Applications would build on Novartis' expertise in diseases associated with NETs and introduce a new technology platform to Novartis providing an innovative approach to treating cancer.

Acquisition would add Lutathera, a first-in-class RadioLigand Therapy (RLT) approved in Europe and under review in the US for neuroendocrine tumors (NETs).Novartis to acquire Advanced Accelerator Applications pending outcome of tender offer and works council consultation.

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