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The senior management and directors of AAA have, in their capacity as shareholders of AAA, undertaken to tender their shares into the proposed tender offer. Novartis will commence a tender offer upon completion of works council consultation and AAA’s board of directors recommending the tender offer to AAA shareholders. The transaction to acquire AAA is planned to be fully funded through external short- and long-term debt. In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (Netspot and SomaKit TOC). 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. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001).
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The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability.
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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.
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“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. This offer values AAA’s equity at RadioLigand Therapy $3.9 billion.Īdvanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera, a first-in-class RadioLigand Therapy (RLT) product for neuroendocrine tumors (NETs).
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Under the terms of the memorandum of understanding, which has been approved by AAA’s board of directors, Novartis will make a cash offer of $41 per ordinary share of AAA and $82 per American Depositary Share (each representing 2 ordinary shares of AAA) subject to certain conditions. Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100 percent of the share capital of AAA subject to certain conditions. Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio.