Gallium-68 P16-093

BURNABY, British Columbia--(BUSINESS WIRE)-- ARTMS Inc. (ARTMS), the global leader in developing and commercializing novel products enabling cyclotron production of the world’s most needed medical radioisotopes, is pleased to announce the submission of a Type 1 Master File with the Health Products & Food Branch, Health Canada (HC) for the production of gallium-68 (Ga-68). Gallium-68 is a critical medical isotope of significant clinical importance in nuclear medicine diagnostic procedures utilizing Positron Emission Tomography (PET) imaging. ARTMS’ Health Canada filing will help alleviate the current supply constraints and provide innovators the ability to advance new radiopharmaceutical drugs into development. On the basis of the filing, ARTMS has also entered into a tri-party co-operation with fellow industry leaders, POINT Biopharma (NASDAQ: PNT) and the Canadian Molecular Imaging Probe Consortium (CanProbe), a joint venture between the Centre for Probe Development and Commercialization (CPDC) and the University Health Network (UHN), for the development and clinical use of innovative radiopharmaceuticals in Canada. “The Ga-68 regulatory filing in Canada is the next step in ARTMS’ goal to prevent the significant supply issues of this important medical isotope. The current supply chain of germanium/gallium generators is inefficient, high cost and at risk for interruption at any time. Any interruptions to the supply chain will negatively impact patients and drug innovators,” explained Charles S. Conroy, Chief Executive Officer of ARTMS. “Our collaborative working relationship with POINT and CanProbe will leverage ARTMS’ proprietary solid target approach to bring important new medicines to Canadians.“ “Increasing the availability and scale of Ga-68 supply through cyclotron production will be important in further accelerating the development and commercialization of next generation radiopharmaceutical therapies,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “We believe ARTMS’ solid target approach to Ga-68 production will play a key role in increasing the availability of this important isotope. We are excited to work with ARTMS and CanProbe in the creation of POINT’s new Ga-based based molecular imaging agents that will enable the development and commercialization of our next generation radiopharmaceutical therapies.” Dr. Bruno Paquin, President of CanProbe and CEO of CPDC, remarked, “Gallium-68 is the critical active component of many radiopharmaceuticals used in the diagnosis and staging of important medical conditions such as prostate cancer and neuroendocrine tumours.” Dr. Paquin further commented that, “ARTMS’ QUANTM Irradiation System enables our facility a 100-fold increase in the availability of Ga-68 over the current generator supply. This significant increase in isotope supply directly impacts our ability to work with innovators such as POINT to meet end-patient needs.” ARTMS continues to drive nuclear medicine’s supply chain into the future through the QUANTM Irradiation System ecosystem by providing a pathway for large scale isotope production of Zr-89, Cu-64 and Tc-99m. Mr. Conroy concluded, “We will continue to support and work with radiopharmaceutical innovators to validate their products with the ARTMS system and have their regulatory filings reference ARTMS’ cyclotron solid target approaches.” About ARTMS Based in Burnaby, British Columbia, Canada, ARTMS Inc. is a 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 SystemTM (QISTM), 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 commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry. For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter @ARTMS_Inc and LinkedIn and visit . About POINT Biopharma POINT Biopharma Global Inc. (NASDAQ: PNT) is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), and industry-leading manufacturing capabilities and supply chain, to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at . About CanProbe CanProbe is a joint venture between the Centre for Probe Development and Commercialization (CPDC) and University Health Network (UHN) to create a Canadian Centre of Excellence for the development, translation, utilization and commercialization of radiopharmaceuticals. CanProbe leverages the strengths of its partners and their affiliates. For more information about CanProbe, please visit: . The Centre for Probe Development and Commercialization (CPDC) is a global leader in the discovery, development and commercialization of next generation radiopharmaceuticals supported by the Networks of Centres of Excellence (NCE), McMaster University and the Ontario Institute for Cancer Research (OICR). With an established pipeline of products and a robust and reliable manufacturing unit, CPDC supplies innovative diagnostic and therapeutic radiopharmaceuticals globally ( ). University Health Network consists of Toronto General and Toronto Western Hospitals, the Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, and The Michener Institute of Education at UHN. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. It has the largest hospital-based research program in Canada, with major research in arthritis, cardiology, transplantation, neurosciences, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. University Health Network is a research hospital affiliated with the University of Toronto.

MELBOURNE, Australia and INDIANAPOLIS, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has today welcomed the updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer,1 which includes prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging modalities, including Ga-68 PSMA-11. Telix’s New Drug Application (NDA) for its investigational imaging product Illuccix® (Kit for the preparation of 68Ga-PSMA-11 injection) is in the late stages of review by the United States Food and Drug Administration. The NCCN Guidelines® are a recognised standard for clinical direction and policy in cancer care and are used widely by clinicians and payors. The NCCN panel has recognised the increased sensitivity and specificity of PSMA-PET tracers, compared to conventional imaging (CT, MRI) for detecting micrometastatic disease, at both initial staging and biochemical recurrence. The updated guidelines state that the NCCN Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as equally effective, if not more effective front-line imaging tools for these patients. The updated guidelines now include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue. Dr Colin Hayward, Chief Medical Officer of Telix said, “This is an important change to the guidelines which will influence a shift in clinical practice to consider PSMA-PET imaging as an alternative to standard imaging of bone and soft tissue for the detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.” “The NCCN guidelines are considered a global standard to guide oncology practice and reimbursement. The inclusion of PSMA-PET imaging, including with Ga-68, the isotope used in our investigational imaging product Illuccix® further signals the emergence of PSMA-PET imaging as a state-of-the-art imaging modality.” Dr Oliver Sartor, Medical Director at Tulane Cancer Center said, “The updated guidelines will encourage clinicians to use PSMA-PET as a primary imaging modality in patients and will deliver the benefit of a more streamlined approach. We look forward to having access to this functional form of imaging as new products come into the market.” About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,2 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).3 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union4 and Canada.5 None of Telix’s products have received a marketing authorisation in any jurisdiction. Telix Media Contact Dr. Stewart Holmstrom Telix Pharmaceuticals Limited Director Corporate Communications Email: stewart.holmstrom@telixpharma.com 1 2 ASX disclosure 24/11/20. 3 ASX disclosure 14/04/21. 4 ASX disclosure 1/05/20. 5 ASX disclosure 16/12/20.