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

April 01, 2025 at 08:49 AM EDT

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 Limited
General Manager of ARTMS & Isotope Strategy
Email: Chad.Watkins@TelixPharma.com

Kevin Reimer
Telix ARTMS, Inc.
VP Global Sales and Marketing
Email: Kevin.Reimer@TelixPharma.com

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: kyahn.williamson@telixpharma.com

Legal Notices

You should read this announcement together with Telix risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.

_______________________

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.

About Us

Laser Focus World Membership

Magazine Subscription

Newsletter Subscription

The Daily Beam

Product Watch

Bio & Life Sciences Product Watch

Laser Processing Product Watch

Get Published!

Photonics Hot List

Following the Photons: A Photonics Podcast

Social Media

Meet the Laser Focus World Team

Editorial

Sales

Editorial Advisory Board

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

More News