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ARTMS Inc. Announces Health Canada Submission for Ga-68 Production and Tri-party Collaboration to Advance Ga-68 Imaging Products

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ARTMS Inc. has submitted a Type 1 Master File to Health Canada for gallium-68 (Ga-68) production, aimed at addressing supply constraints of this vital medical isotope used in PET imaging. This strategic move includes a collaboration with POINT Biopharma and CanProbe to enhance the development of innovative radiopharmaceuticals in Canada. The Ga-68 regulatory filing is intended to improve supply chain efficiency and reduce costs while increasing availability through ARTMS' QUANTM Irradiation System, expected to significantly boost Ga-68 production capacity.

Positive
  • Submission of a Type 1 Master File to Health Canada for Ga-68 production.
  • Partnership with POINT Biopharma and CanProbe for innovative radiopharmaceutical development.
  • Expected significant increase in Ga-68 supply through ARTMS’ QUANTM Irradiation System.
Negative
  • None.

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 http://www.artms.ca/.

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 https://www.pointbiopharma.com.

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: www.canprobe.ca.

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 (www.imagingprobes.ca).

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.

ARTMS Corporate

Charles S. Conroy R.Ph, MBA

ARTMS, Inc.

Chief Executive Officer

Email: conroy@artms.ca

ARTMS Investor and Business

Doug Gentilcore

ARTMS, Inc.

Chief Commercial Officer

Email: gentilcore@artms.ca

Source: ARTMS Inc.

FAQ

What is the significance of ARTMS' Type 1 Master File submission regarding gallium-68?

The submission aims to address current supply constraints of gallium-68, a critical medical isotope for PET imaging.

How will ARTMS' collaboration with POINT Biopharma impact gallium-68 availability?

The collaboration is expected to enhance the development and commercial availability of innovative radiopharmaceuticals using gallium-68.

What technology is ARTMS utilizing for gallium-68 production?

ARTMS employs its QUANTM Irradiation System to increase the capacity for gallium-68 production significantly.

What role does POINT Biopharma play in ARTMS' gallium-68 initiative?

POINT Biopharma collaborates with ARTMS to develop new Ga-based molecular imaging agents, enhancing radiopharmaceutical therapies.

What are the potential benefits of ARTMS’ QUANTM Irradiation System?

The QUANTM Irradiation System is anticipated to provide a 100-fold increase in Ga-68 supply compared to current production methods.

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