The acquisition will add to the company’s oncology portfolio.
Pending the acceptance of their tendered offer, Novartis announced its plans on October 30 to acquire novel radiopharmaceutical cancer therapy innovator Advanced Accelerator Applications for $3.9 billion in cash.
With the acquisition, Novartis will acquire Advanced Accelerator Applications’ Lutathera®, a first-in-class RadioLigand Therapy (RLT) approved in Europe and under review in the US for neuroendocrine tumors (NETs). According to Novartis, radiopharmaceuticals like Lutathera (177Lu-DOTATATE), are unique formulations that contain radioisotopes used by oncologists clinically for both diagnosis and therapy.
Bruno Strigini, CEO of Novartis Oncology, commented on the deal, noting: "Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients. 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 said Lutathera was approved in Europe in September for the treatment of unresectable or metastatic, progressive well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). According to the company, the radiopharmaceutical is under US FDA review with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018. According to Novartis, the efficacy and safety of the drug was established in its pivotal NETTER-1 Phase III trial and meeting its primary endpoint with a statistically and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy.
In addition to Lutathera, Advanced Accelerator Applications brings an expanded pipeline of RLT programs with significant sales potential, including 177Lu-PSMA-R2 entering Phase I-II for prostate cancer.