DUBLIN, Ohio & INDIANAPOLIS--(BUSINESS WIRE)--As interest and demand for more accurate prostate cancer imaging grows, and with the approval of the first Ga-68 PSMA based prostate imaging agent late last year1, Cardinal Health Nuclear & Precision Health Solutions (Cardinal Health) and Telix Pharmaceuticals (US) Inc. (Telix) have developed an in-depth white-paper, entitled: “Moving beyond the Myth: Meeting the growing demand for Ga-68 radiopharmaceuticals.” The paper shines a light on the pathways for radio-isotope production, distribution and clinical application, as well as highlighting the extensive systems already in place to help ensure potential demand for Ga-68 imaging products is met.
Despite major disruption caused by COVID-19, 2020 saw two new drug applications (NDA) and an approval by the U.S. Food and Drug Administration (FDA) for the first 68Ga- PSMA-11 product for prostate cancer imaging albeit restricted to use in two academic institutions1. Since then, interest has been building in anticipation of other gallium-based imaging options currently under review by the FDA.
“A key to satisfying the demand for this isotope lies in having a robust network of radiopharmacies like Cardinal Health,” said Dr. Christian Behrenbruch, Chief Executive Officer of Telix Pharmaceuticals Limited. “There is a perception in the industry that supply chain issues may limit the availability of gallium-based radiopharmaceuticals. Whilst this may have been true historically, this is no longer the case. The strength and power of gallium lies in its flexibility, with production by either cyclotron or generator. This offers greater flexibility and opportunity for scale than other purely cyclotron-based isotopes. Subject to regulator approval, we look forward to offering state-of-the-art diagnostic imaging to U.S. men living with prostate cancer, and Cardinal Health’s radiopharmacy network and infrastructure will be vital in facilitating nationwide access.”
Cardinal Health Nuclear & Precision Health Solutions offers an extensive network of over 130 pharmacies, of which more than 110 are licensed to process 68Ga. Besides distribution efficiencies, Cardinal Health’s Accutrac® system tracks doses during transit from the pharmacy to the site of care, enabling a greater than 99% on-time delivery record to help ensure doses are delivered where they are needed, when they are needed. “Patient and physician satisfaction is our top priority,” says Tiffany Olson, President of the Cardinal Health Nuclear & Precision Health Solutions business. “Telix Pharmaceuticals is developing gallium-based innovations to advance prostate cancer imaging, and Cardinal Health is ready to help meet that demand.”
The white-paper is available for free download at: www.cardinalhealth.com/gallium68.
About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 40 countries and approximately 48,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.
About Telix Pharmaceuticals Limited
Telix is a clinical-stage 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 needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com 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.
2 ASX disclosure 24/11/20.
3 ASX disclosure 14/04/21.
4 ASX disclosure 1/05/20.
5 ASX disclosure 16/12/20.