Novartis said on Monday that it wants to buy Advanced Accelerator Applications (AAA), a radiopharmaceutical company that owns and sells Molecular Nuclear Medicines including Lutathera, a product for neuroendocrine tumors (NETs).
Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. 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.
Bruno Strigini, CEO, Novartis Oncology, said that with Lutathera, Novartis can expand the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.
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). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.
The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1, which met its primary endpoint. Namely, Lutathera had 79% reduction in risk of disease progression or death compared to the control therapy. At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.
In addition to Lutathera, AAA more upcoming radiopharmaceuticals, including the companion diagnostics for Lutathera, like NETSPOT and SomaKit TOC(TM). Novartis pointed out that AAA had sales of EUR 109 million in 2016.