Novartis Slams Down $3.9B for This French Cancer Biotech
Novartis announced its intentions to acquire the oncological company and its lead product, Lutathera, a first-in-class RLT product for neuroendocrine tumors. In September, the European Medicines Agency approved Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
As could be expected, shares of AAA shot up more than 10 percent in pre-market trading this morning, hitting $80.50. Novartis said the acquisition of AAA will strengthen the company’s oncology presence with near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
"Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients," Bruno Strigini, chief executive officer of Novartis Oncology, said in a statement. "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."
In Phase III trials, Lutathera demonstrated statistically significant and clinically meaningful 79 percent reduction in risk of disease progression or death. The U.S. Food and Drug Administration is expected to make a decision on Lutathera by Jan. 26, 2018. AAA initially sought U.S. approval in 2016, but the FDA sent a Complete Response Letter citing issues with the Phase III trial, including format, traceability, uniformity, and completeness. The CRL also requested subgroup analyses for gender, age and racial subgroups, as well as other stratification factors and important disease characteristics, and a safety update on clinical and non-clinical studies. AAA addressed those issues and resubmitted for approval.
With the acquisition of AAA, Novartis picks up several manufacturing facilities in the United States, including a 15,000 square-foot manufacturing facility in New Jersey. AAA acquired the facility in 2016 to develop the company’s Somakit products, called Netspot, which received approval from the FDA in the summer of 2016. Netspot is a patented kit developed for the preparation of Ga 68 dotatate for injection, for radiolabeling somatostatin analogue peptides to help diagnose somatostatinreceptor-positive neuroendocrine tumors (NETs) lesions.
In August, AAA reported 32 percent growth in sales for the second quarter that ended June 30. At the time, Strigini said Netspot was a key driver for the company, with about 180 places in the United States using the product. Additionally, he said the company was also seeing sales growth throughout Europe. Last year, the company reported about €109 million (about $126 million) in annual sales.