ARTMS Drug Master File for Gallium Production Technology Referenced with Telix's Gozellix®

Yahoo

29-04-2025

BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF)1 for gallium-68 production using its QUANTM Irradiation System® (QIS®) cyclotron technology has been referenced for the first time with a United States (U.S.) Food and Drug Administration (FDA) approved product, with Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection).
This approval will enable radiopharmacies and hospitals using ARTMS' QIS® cyclotron technology and associated targets to produce multi-Curies of 68Ga for use with Gozellix®. The expanded distribution radius and increased dose production capacity, compared to existing gallium-based PET tracers, will facilitate broader and more equitable access. In addition, use of ARTMS' technology is being expanded internationally where regulatory submissions are in preparation. Pharmaceutical companies will be able to reference ARTMS' standardized isotope production technology with their approved drugs, helping to localize and simplify manufacturing.
Chad Watkins, General Manager ARTMS and Isotope Strategy, Telix, said, 'This DMF reference represents a significant milestone for ARTMS, our partners and customers. The combination of these innovative technologies reflects Telix's commitment to working in partnership to reach more patients with 68Ga-PSMA-11, where and when they need it.'
The QIS® forms part of ARTMS' 'turnkey' solution for customers that encompasses in-house manufactured targets and chemistry processing of isotopes, as well as DMF preparation and filing support. This makes large scale isotope production for hospitals and radiopharmaceutical distributors with cyclotrons significantly more attainable than with other existing technologies.
ARTMS will continue to support the high efficiency, large-scale and cost-effective production of commercially important medical isotopes such as zirconium-89 (89Zr), gallium-68 (68Ga), technetium‐99m (99mTc) and copper-64 (64Cu), and will continue to partner with additional radiopharmaceutical companies to ensure that these critical isotopes are available on demand for patients. In addition, ARTMS' portfolio of advanced cyclotron technologies has application for Telix and select partners in the production of future commercially important alpha-emitting, therapeutic isotopes, including actinium-225 (225Ac) and astatine-211 (211At).
For further information please contact:
Chad Watkins Telix Pharmaceuticals LimitedGeneral Manager of ARTMS & Isotope StrategyEmail: [e-mail]
Kevin ReimerTelix ARTMS, Inc.VP Global Sales and MarketingEmail: [e-mail]
About Telix ARTMS, Inc.
Based in Burnaby, British Columbia, Canada, Telix ARTMS, Inc. (ARTMS) is the global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world's most-used diagnostic imaging isotopes. ARTMS' flagship product, the QUANTM Irradiation System® (QIS®), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS was acquired by Telix Pharmaceuticals in April 20242. For more information on QIS® and ARTMS, please follow us on X @ARTMS_TLX and LinkedIn and visit www.artms.ca/
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA3.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
Telix Investor Relations
Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [e-mail]
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1 A DMF is a submission to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.2 Telix ASX disclosure 11 April 2024.3 Telix ASX disclosure 21 March 2025.Sign in to access your portfolio