July 26, 2016
By Alex Keown, BioSpace.com Breaking News Staff
MILLBURN, N.J. – French drugmaker Advanced Accelerator Applications S.A. has secured a physical toehold in the United States, opening a 15,000 square-foot manufacturing facility in New Jersey, it’s first such facility in America, the company announced this morning.
The site, which is now operational, will be used to develop the company’s recently approved Somakit products, called Netspot, which received approval from the U.S. Food and Drug Administration last month. 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. Last month, shortly after the FDA cleared Netspot, AAA struck a supply deal with Triad Isotopes, Inc. and Nuclear Diagnostic Products, Inc. to provide to supply the Netspot doses to hospitals across the United States. Triad and NDP will each prepare and deliver Netspot patient doses to advanced medical imaging sites in selected metropolitan areas, the company said in June.
The New Jersey manufacturing plant marks the 22nd such site the company maintains globally, Stefano Buono, chief executive officer of Saint-Genis-Pouilly, France-based AAA, said in a statement.
Additionally the New Jersey site will include 12 production lines dedicated to the production of the company’s cancer drug, Lutathera, an experimental Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastro entero pancreatic neuroendocrine tumors (NETS), such as foregut, midgut, and hindgut neuroendocrine tumors, the company said on its website. The drug has received orphan drug designation from the European Medicines Agency and the U.S. Food and Drug Administration (FDA). In April 2015, the FDA also granted the drug a fast-track designation for the treatment of inoperable progressive midgut NETs.
The site will also be used to manufacture Oxygen-18 enriched water, an important precursor for the production of fluorodeoxyglucose used in Positron Emission Tomography. The specialized water will be distributed by the new facility on behalf of Marshall Isotopes, a subsidiary of Advanced Accelerator Applications.
Advanced Accelerator Applications’ new New Jersey site was selected due to its proximity to Newark airport, which will enable quick transportation of Lutathera and other drugs to hospitals and treatment centers across the country, the company said.
“… we believe this facility will provide us with sufficient capacity to meet future demand for Lutathera in the North American market and manage distribution of our new generation of PET products,” Buono said.
The site will begin with 15 pharmaceutical manufacturing, sales and marketing, and administrative employees, but Advanced Accelerator Applications said there are plans to expand employment to 50. Advanced Accelerator Applications employs more than 450 people in 13 different countries.
