Technetium Tc-99m red blood cells (CURIUM)

Builds on existing collaboration between Curium and Lantheus for prostate cancer PSMA-targeted PET imagingDeep-learning platform for standardization of comprehensive reporting in Europe PARIS, July 25, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today a ‘License and Development’ agreement with EXINI Diagnostics AB, a Lantheus company (EXINI), to customize EXINI’s artificial intelligence (AI) platform for use in Europe. The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments. Today’s announcement follows the May 2023 decision by the Committee for Medicinal Products for Human Use of the European Medicines Agency that recommended granting a marketing authorization for PYLCLARI® (piflufolastat (18F)), intended for the diagnosis of prostate cancer. Under the terms of the agreement, EXINI’s deep learning platform will be tailored to meet the specific needs of the European market. The clinical value proposition of the platform is to increase the efficiency and reproducibility of PSMA PET/CT image assessments in prostate cancer and establish the standard for comprehensive reporting across the US and Europe. The deep learning algorithm will be trained on anonymized data from Curium’s European Phase III PYTHON (NCT04734184) clinical trial, in addition to the existing dataset from the two U.S. registrational studies (OSPREY - NCT02981368 and CONDOR - NCT03739684) of piflufolastat F18. The AI-enabled assessment will assist in bringing increased consistency, reliability, and efficiency in reporting PSMA-avid total disease burden and in monitoring its change with treatments. Benoit Woessmer, CEO PET Europe at Curium commented: “By leveraging artificial intelligence and the extensive anonymized data from our European PYTHON clinical trial, this is an important milestone in enhancing prostate cancer diagnosis, and indeed for the patients themselves. We are excited about using deep learning to help us redefine the experience of cancer through our trusted legacy in nuclear medicine.” Etienne Montagut, Chief Business Officer at Lantheus commented: “PSMA PET has had an important impact on prostate cancer management. With the expanding treatment options in prostate cancer, including PSMA RLT, there is increasing demand for efficient, standardized quantitative assessment of PSMA disease burden. Our partnership with Curium expands the pool of patient data informing our AI algorithm and enables more widespread access to our software.” About Curium Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information: Ross BethellVP, Head of Global Communicationcommunications@curiumpharma.com

If approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging.Proven track record of [18F]-DCFPyL (branded as PYLARIFY® in the U.S.), with more than 100,000 prostate cancer patient scans performed in 2022 in the U.S. PARIS, May 26, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) for primary staging of patients with high-risk PCa prior to initial curative therapy and to localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “This positive CHMP opinion for PYLCLARI® is an important step forward in our goal of redefining the experience of cancer through our trusted legacy in nuclear medicine. We are extremely pleased with the CHMP positive opinion and recommendation to grant a marketing authorization in Europe for PYLCLARI®, a diagnostic imaging medicine for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer, based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S.” Benoit Woessmer, PET Europe CEO at Curium added, “This CHMP positive opinion is a very important milestone for Curium, our customers, and their patients. Upon its approval, PYLCLARI® will become available across Europe to help patients along their prostate cancer journey. We are very excited to bring PYLCLARI® to the market and contribute to improving the set of diagnostic tools available to better diagnose and monitor prostate cancer. PSMA PET with PYLARIFY® is the standard of care in the U.S. We are looking forward to answering the high expectations of the nuclear medicine community when it comes to having the right tool reliably available to address this fast-growing pathology.” Curium submitted its Marketing Authorization Application for Piflufolastat (18F) to the EMA in July 2022. The CHMP’s positive opinion on PYLCLARI® will be referred to the European Commission, which will deliver a final decision in approximately two months. In the U.S., [18F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. About CuriumCurium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross BethellVP, Head of Global Communicationscommunications@curiumpharma.com