Novartis noted in its announcement yesterday that the NETTER-1 trial demonstrated a 79% reduction in the risk of disease progression, with an interim median progression-free survival rate of 8.4 months that had yet to max out. Improve the format, traceability, uniformity, and completeness relating to clinical data-including from the Phase III NETTER-1 trial, which generated positive results.Provide a safety update on clinical and nonclinical studies.Conduct subgroup analyses for gender, age, and racial subgroups, as well as other stratification factors and “important” disease characteristics.The first review in December 2016 ended with a Complete Response Letter directing AAA to: In the U.S., the FDA has set a Prescription Drug User Fee Act (PDUFA) target decision date of January 26, 2018, for Lutathera. Lutathera, which is designed to treat NETs, last month won European Commission approval for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Novartis said the deal would also boost its oncology portfolio, both short-term through product launches and long-term through a new technology platform it said had potential applications across a number of oncology early development programs. “We have long felt would be an ideal partner, not only to enhance the launch of … Lutathera for neuroendocrine tumours, but especially to accelerate the advancement of our unique oncology theragnostic platform,” said AAA’s chef executive Stefano Buono.Novartis said it intends to acquire Advanced Accelerator Applications (AAA) for $3.9 billion cash, in a deal designed to expand the buyer’s neuroendocrine tumor (NET) pipeline with radiopharmaceutical candidates led by the first-in-class RadioLigand Therapy (RLT) Lutathera® (177Lu-Dotatate), now under FDA re-review. The deal is still subject to a tender offer and consultations with workers at the Saint-Genis-Pouilly-based biopharma company. Novartis is offering $41 in cash per AAA ordinary share and $82 per American Depositary Share, and says it intends to fund the acquisition with debt. The transaction gives Novartis “both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programmes”, said the firm’s oncology head Bruno Strigini in a statement.Īmong AAA’s clinical candidates is 177Lu-NeoBOMB1, a radiopharmaceutical for prostate cancer, gastrointestinal stromal tumours (GIST) and breast cancer. The first patient was recently treated with the drug in Japan, where it is partnered with Fujifilm RI Pharma. The Swiss pharma giant said this morning that the deal would help strengthen its cancer therapy businesses, adding an approved radiopharmaceutical drug - Lutathera (177Lu- oxodotreotide) for gastroenteropancreatic neuroendocrine (GEP-NET) tumours and two marketed imaging agents - as well as a pipeline of products based on radioisotopes in development for both the diagnosis and therapy of tumours.ĪAA specialises in pairing radiolabelled diagnostics with matched therapeutics - an approach it calls theragnostics, and sales of its marketed products, currently led by NetSpot PET imaging agent, reached in the first half of the year reached around $79m, although it made a net loss of $24m.ĪAA claimed EU approval for Lutathera last month and has filed it for approval in the US, with a verdict due from the FDA in January, and Novartis says it can “build on this legacy by expanding the global reach of this novel, differentiated treatment approach”. Novartis has agreed a $3.9bn deal to buy Advanced Accelerator Applications, a French company specialising in nuclear medicines used to treat tumours.
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