On Track to Resubmit NDA for lutetium Lu 177 dotatate (Lutathera®) to FDA in Mid-2017
NETSPOT® Unit Sales per Month Jump 140% During First Quarter
First Quarter 2017 Highlights:
- Advanced preparations for resubmission of lutetium Lu 177 dotatate (Lutathera®) New Drug Application to FDA
- Results of Phase 3 NETTER-1 study of investigational drug lutetium Lu 177 dotatate (Lutathera®) published in The New England Journal of Medicine
- Enhanced supply chain for lutetium 177-labeled products through a ten-year exclusive supply agreement with the University of Missouri Research Reactor (MURR®)
- More than 80 patients and 15 centers in the US and over 1,600 patients and 60 centers in Europe were participating in the lutetium Lu 177 dotatate (Lutathera®) Expanded Access and compassionate use and named patient programs at March 31, 2017
- NETSPOT® included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for NETs
- Sales for the first quarter of 2017 increased 21% compared to the first quarter of 2016
- NETSPOT® unit sales per month increased 140% (from 232 to 559) between December 2016 and March 2017
SAINT-GENIS-POUILLY, France, May 31, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the first quarter ended March 31, 2017.
Stefano Buono, Chief Executive Officer of AAA, commented, “2017 is off to a strong start. Sales of NETSPOT® in the US continue to grow rapidly, as we expand our national network of partner radiopharmacies. More than 100 institutions across the US are already using NETSPOT®, and we are currently delivering doses at a run rate of approximately 800 per month. We are proud of NETSPOT®’s positive impact on the neuroendocrine tumor (NET) community, which was recently recognized by the National Organization for Rare Disorders.”
“As we look forward to the rest of the year, we are focused on executing a successful launch for SomaKit TOC™ in Europe, preparing for potential approvals of lutetium Lu 177 dotatate (Lutathera®) in Europe and the US, and advancing development of our theragnostic pipeline, including PSMA-R2 and NeoBOMB1. We remain on track for our mid-year resubmission of the New Drug Application for lutetium Lu 177 dotatate (Lutathera®) to the US Food and Drug Administration, and believe the European Medicines Agency will complete its review of the marketing authorization in the third quarter. As this process moves forward, we continue to provide access to treatment with lutetium Lu 177 dotatate to qualifying NET patients in the US and Europe through our ongoing Expanded Access and compassionate use programs. To date, more than 100 patients in 17 centers in the US and over 1,640 patients in 60 centers in Europe have already received treatment under these initiatives.”
First Quarter 2017 Financial Results
Total sales for the first quarter of 2017 were €32.6 million (US$34.9 million(1)), a 21% year-on-year increase compared to €26.9 million (US$28.8 million(1)) in the first quarter of 2016. The increase in sales was primarily driven by the PET product category, which increased 41% to €22.4 million (US$24.0 million(1)), compared to €15.9 million (US$17.0 million(1)) in the prior year’s period. US sales of NETSPOT® for the first quarter of 2017 were €3.7 million (US$4.0 million1); there were no sales of NETSPOT® in the first quarter of 2016, as the drug was not yet approved. Therapeutic sales for the first quarter were €5.3 million (US$5.7 million(1)), compared to €5.6 million (US$6.0 million(1)). SPECT sales for the first quarter were €2.3 million (US$2.5 million(1)), compared to €2.2 million (US$2.4 million(1)) for the first quarter of 2016. First quarter sales of other products were €2.6 million (US$2.8 million(1)), compared to €3.2 million (US$3.4 million(1)) for the same period in 2016.
Operating loss for the first quarter was €6.5 million (US$7.0 million(1)), compared to a loss of €1.1 million (US$1.2 million(1)) for the prior year’s period. The Company experienced higher research and development and operating costs during the first quarter of 2017, primarily related to the launch of new products and associated increases in compliance requirements, as well as growth in headcount.
