Advanced Accelerator Applications Announces Opening of First U.S. Manufacturing Facility; Preparation for Anticipated Lutathera Launch

AAA today announced the opening of its first U.S. manufacturing facility in Millburn, NJ.

The 15,000 square foot facility features 12 production lines dedicated to Lutathera, as well as storage and office space. The site is conveniently located near Newark airport, enabling future delivery of Lutathera directly to hospitals and treatment centers around the country. There are currently more than 15 pharmaceutical manufacturing, sales and marketing, and administrative employees working on site, with plans to expand to 50 people.

In addition, the Millburn plant serves as a distribution center for NETSPOT™, a AAA product recently approved by the U.S. Food and Drug Administration for the preparation of Gallium Ga 68 dotatate for injection, a first in class drug for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (“PET”). Oxygen-18 enriched water, an important precursor for the production of fluorodeoxyglucose used in PET, is also distributed by the new facility on behalf of Marshall Isotopes, a AAA company.

“We are excited to have our first U.S. manufacturing facility operational in preparation for the anticipated approval and launch of Lutathera,” said Stefano Buono, Chief Executive Officer of AAA. “The Millburn plant is our 22nd manufacturing site globally and 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.”