AAA today announced its financial results for the second quarter of 2016. Commenting on the second quarter performance, Stefano Buono, AAA’s CEO, said: “We are very excited about the launch of our first FDA approved product in the U.S. We have established national distribution for NETSPOTTM (Somakit-TATE) and are pleased by the initial demand and patient support we have received. In the meantime, we are quite encouraged by the Priority Review designation for Lutathera and that patients are starting to receive treatment under the U.S. Expanded Access Program. These developments and the establishment of our first U.S. facility further support our preparations for launch in both the U.S. and Europe.” Buono added, “We look forward to continuing our momentum in the second half of 2016, with the December 28 PDUFA date for Lutathera, and our plans to begin advancing the NeoBOMB1 and PSMA assets into clinical development.”
Second Quarter Highlights:
– Sales for the second quarter of 2016 increased 24.4% compared to the second quarter of 2015
– The U.S. Food and Drug Administration (FDA) granted Priority Review for Lutathera, with a Prescription Drug User Fee Act (PDUFA) target action date of December 28, 2016
– First patient was treated with Lutathera under the U.S. Expanded Access Program
– The FDA approved NETSPOTTM (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography
– Established first U.S. distribution and future production site
– Expanded theragnostic pipeline with NeoBOMB1, a novel GRPR antagonist in development for gastrointestinal stromal tumors, prostate cancer and breast cancer
– Acquired two F-18 production sites in Germany