The Company experienced higher personnel costs and operating expenses during the second quarter of 2017, primarily related to the launch of new products, ongoing pipeline development and increases in Operating loss for the second quarter was €6.0 million (US$6.8 million (1)), compared to a loss of €1.0 million (US$1.1 million (1)) for the prior year period. Million (US$3.3 million (1)) for the same period in 2016. Second quarter sales of other products were €3.4 million (US$3.9 million (1)), compared to €2.9 SPECT sales for the second quarter were €2.5 million (US$2.9 million (1)),Ĭompared to €2.4 million (US$2.7 million (1)) for the second quarter of 2016. Quarter were €5.4 million (US$6.2 million (1)), compared to €5.6 million (US$6.4 million (1)). This includes €7.2 million (US$8.2 million 1) in US sales of NETSPOT ® in the second quarter. The increase in sales was primarily driven by the PET product category, which increased 50% to €25.2 million (US$28.8 million (1)), compared to €16.8 million (US$19.2 Total sales for the second quarter of 2017 were €36.5 million (US$41.7 million (1)), a 32% increase compared to €27.6 million (US$31.5 million (1)) in the second While this process unfolds, we will keep working with US EAP centers to provide lutetium Lu 177 dotatate* (Lutathera ®) to the now NDA to the FDA, so the Agency’s review may continue. Similarly, we are glad to have completed the resubmission of our We look forward to the European Commission’s final review of the Marketing Authorization Application. (Lutathera ®) is a historical first for Peptide Receptor Radionuclide Therapy (PRRT), and we are hopeful that the recommended GEP-NET indication will provide physicians with the ability to The positive CHMP opinion for lutetium Lu 177 dotatate* “We have made great progress towards having our first oncology theragnostic pairing for NETs on the market. The European roll out of SomaKit TOC ™ is also progressing well, withĭoses being sold in the UK, Italy, Poland and Germany.” NETSPOT ® remains a keyĭriver for revenue growth in our PET business, with almost 180 institutions in the US actively administering the drug.
Stefano Buono, Chief Executive Officer of AAA, commented, “We are pleased by our continued momentum as we move through the second half of 2017. Specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the second quarter ended June 30, 2017. (NASDAQ: AAAP) (AAA or the Company), an international Progressive, advanced, inoperable NETs arising at all sitesġ40 patients and 23 centers in the US and 1,800 patients and 62 centers in Europe were participating in the lutetium Lu 177 dotatate* (Lutathera ®) Expanded Access andĬompassionate use and named patient programs at July 31, 2017Īugust 31, 2017, Saint-Genis-Pouilly, France - Advanced Accelerator Applications S.A. User Fee Act (PDUFA) date of January 26, 2018įDA allowed an amendment to the protocol for the US Expanded Access Program (EAP) for lutetium Lu 177 dotatate* (Lutathera ®) expanding enrollment to patients with Received positive opinion for lutetium Lu 177 dotatate* (Lutathera ®) for the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults from theĬommittee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)Ĭompleted resubmission of lutetium Lu 177 dotatate* (Lutathera ®) New Drug Application (NDA) to the US Food and Drug Administration (FDA) and received Prescription Drug
NETSPOT ® unit sales per month increased 63% (from 562 to 915) from March to June 2017 Sales for the second quarter of 2017 increased 32% compared to the second quarter of 2016 Positive CHMP Opinion for Lutetium Lu 177 Dotatate* (Lutathera ®) for GEP-NETSįDA Acknowledged Receipt and Completeness of NDA Resubmission for Lutetium Lu 177 Dotatate* (Lutathera ®) and Provided PDUFA Date of January 26, 2018 ENT> EX-99.1 2 dp79915_ex9901.htm EXHIBIT 99.1Īdvanced Accelerator Applications Reports 32% Sales Growth for Second Quarter 2017
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