Print Page     Close Window     

SEC Filings

SC14D9C
ADVANCED ACCELERATOR APPLICATIONS S.A. filed this Form SC14D9C on 11/17/2017
Entire Document
 
 

 

 

 

The FDA allowed production of lutetium Lu 177 dotatate* (Lutathera®) EAP doses at AAA’s Millburn, New Jersey site.

 

On August 28, the Company announced that the FDA has acknowledged receipt and considered complete the resubmission of the NDA for lutetium Lu 177 dotatate* (Lutathera®). The Agency provided a new PDUFA action date of January 26, 2018.

 

On September 6, the Company announced that the first patient was treated in a Phase I clinical study of lutetium Lu 177 dotatate* (Lutathera®) in patients with inoperable, somatostatin receptor positive, progressive pancreatic, gastrointestinal, or pulmonary NETs in Japan. The primary objective of this open-label, uncontrolled, single-center, bridging study is to evaluate the safety, tolerability, pharmacokinetics, and dosimetry of lutetium Lu 177 dotatate* (Lutathera®) in Japanese patients.

 

* USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide

 

-------

 

About USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide (Lutathera®)

 

USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) is an investigational 177Lu-labeled somatostatin analog peptide. USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting tumors with radiolabeled molecules that bind to specific receptors expressed by the tumor. The European Commission approved the marketing authorization of USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs in adults. An NDA submission to the US Food and Drug Administration (FDA) for lutetium Lu 177 dotatate (Lutathera®) is under review. The Prescription Drug User Fee Act (PDUFA) action date is January 26, 2018. This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

 

About Advanced Accelerator Applications S.A.

 

Advanced Accelerator Applications (NASDAQ:AAAP) is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform is based on radiolabeling a targeting molecule with either gallium Ga 68 for diagnostic use, or lutetium Lu 177 for therapy. AAA’s first theragnostic pairing for neuroendocrine tumors includes diagnostic drugs NETSPOT® in the US and SomaKit TOC® in Europe; and therapeutic USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®), which is approved for use in Europe and currently under review with the FDA. Additional theragnostics in development target gastrointestinal stromal tumors (GIST), and prostate and breast cancer. AAA is also an established leader in molecular nuclear diagnostic radiopharmaceuticals for PET and SPECT, mainly used in clinical oncology, cardiology and neurology. Headquartered in Saint-Genis-Pouilly, France, AAA currently has 21 production and R&D facilities, and more than 550 employees in 13 countries (France, Italy, the UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the US and Canada). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com.

 

3 


© -20 Advanced Accelerator Applications - All rights reserved .