123I-CMICE-013

SYDNEY, May 11, 2021 /PRNewswire/ -- Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce the appointment of Shaemus Gleason as Executive Vice President U.S. Operations as the company expands its presence, clinical trials, and operations in the U.S. Shaemus joins Clarity from Bayer's Oncology Strategic Business Unit where he has been employed since 2018, most recently as Global Radiopharmaceuticals Strategic Operations Leader responsible for the oversight of global clinical and isotope supply, clinical site setup, radiation safety, and nuclear regulatory strategy. Shaemus' background in radiopharmaceutical development and operations is extensive with over 12 years of experience in radiopharmaceuticals, including his experience at Algeta ASA (Algeta) from 2013, throughout Algeta's acquisition by Bayer for US$2.9 billion in 2014, and at Bayer AG following the acquisition. As a National Director of the Radiotherapy Specialist team, Shaemus was responsible for commercial management of the radiotherapy group at Algeta/Bayer and was heavily involved in the development, launch, manufacture, and logistics of Xofigo, Algeta's lead radiopharmaceutical product targeting metastatic prostate cancer. Prior to Algeta, Shaemus was on the management team of Cardinal Health's iodine-123 manufacturing facility in Denver, Colorado, working within the Health/Radiation Physics department. The facility provided central manufacturing and supply of diagnostics agents with very similar half-lives to copper-64, expertise he now brings to Clarity. Shaemus was also instrumental in setting up the dispensing and distribution facility for Xofigo. Shaemus commented on his appointment, "I am looking forward to joining Clarity at this important stage of development when the company is rapidly expanding its clinical program as well as setting up logistics and central manufacture of products for its theranostic SARTATETM and SAR-bisPSMA trials in the United States. Clarity's SAR Technology platform utilising the perfect pairing of 64Cu/67Cu offers significant advantages for manufacturing and distribution of radiopharmaceuticals, as compared to other targeted therapy agents. This is a transformative moment in the development of beta-based theranostics, with recent results of the VISION trial showing that a beta-emitter based therapy (Lu-177-PSMA) provides an overall survival advantage in solid tumours. For several reasons related to supply considerations and radiobiology, the perfect pairing of 64Cu/67Cu has many advantages over other isotope pairings in development and in the market. As such, I am very excited to be joining the team at Clarity, including a number of my former colleagues from Algeta, and to apply the experience I gained at Bayer, Algeta, and Cardinal Health to Clarity's pipeline of radiopharmaceutical products in development." Clarity's Executive Chairman, Dr Alan Taylor, commented, "We are very pleased to have an executive of Shaemus' capability joining Clarity. We believe that his unique experience in radiopharmaceutical strategy and operations will be invaluable to our expansion in the U.S. as Clarity increases the focus on clinical trials in the region and regulatory discussions with the U.S. Food and Drug Administration, setting up central manufacture, and developing isotope supply chain suitable for commercialisation across the entire platform. We are looking forward to working closely together on growing Clarity internationally as we progress our goal of developing better treatments for children and adults with cancer." About Clarity Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted therapies based on its SAR Technology Platform for the treatment of cancer and other serious diseases in adults and children.