Perspective Therapeutics Acquires CGMP-Compliant Manufacturing Facility - Seite 2

“We are thrilled to expand our manufacturing and supply chain infrastructure to include this facility capable of operating in compliance with Parts 212 and 211,” said Thijs Spoor, Chief Executive Officer, Perspective Therapeutics. “The acquisition is a testament to our commitment to making our targeted alpha-particle therapies available to patients in critical need, and builds on our strategic expansion as we look to establish facilities in proximity to major treatment hubs in the U.S.”

“We are excited for the opportunity to strengthen our strategic collaboration with Perspective Therapeutics,” said Brian Markison, Chief Executive Officer, Lantheus. “We recognize the transformative potential of Perspective’s alpha therapies and platform which we believe have the potential to improve efficacy, while minimizing toxicity across a range of tumor settings. We are pleased the Somerset facility will be used to manufacture these innovative product candidates.”

About Part 211 and Part 212
Part 211 of Title 21 of the Code of Federal Regulations (CFR) outlines the Current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products. It covers various aspects of pharmaceutical manufacturing, including facilities, equipment, controls, and processes to ensure the quality and safety of the final products. Part 212 of Title 21 of the CFR specifically pertains to the cGMP requirements for the manufacturing of positron emission tomography (PET) drugs. PET drugs are radiopharmaceuticals used in medical imaging, and Part 212 sets forth requirements tailored to their unique production processes and quality control measures. The main difference between Part 211 and Part 212 lies in their focus areas, with Part 212 catering to the specialized needs of PET drug manufacturing. Like drugs used for PET, Perspective anticipates that its ²⁰³Pb-labelled peptides will be regulated under Part 212. Like other manufactured drugs, Perspective anticipates that ²¹²Pb-labelled peptides will be regulated under Part 211.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope ²¹²Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.