PARIS, February 22, 2024 (GLOBE NEWSWIRE) — Curium, the world leader in nuclear medicine, today announced the marketing authorization application for Pilculari.® (INN: Pifluforastat (18F) Previously (18F)-DCFPyL) was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) by the exclusive Swiss distributor beimageing AG on January 31, 2024 and accepted for evaluation.
Pill Clary® has been indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adult prostate cancer (PCa) patients in the following clinical settings:
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Primary staging of high-risk PCa patients before first curative therapy
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Locating PCa recurrence in patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels after first-line treatment with curative intent
Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for approximately 23 percent of all new cancer cases in men and approximately 10 percent of all cancer deaths in men in 2020. occupied.
Dr. Michel Wuillemin, Head of Radiopharmaceuticals at beimaging, commented:“beImaging is proud to announce that we have submitted a marketing authorization application for PYLCLARI.”® I went to Swissmedic earlier than planned. We are committed to improving the situation for prostate cancer patients in Switzerland. ”
Benoit Wossmer, CEO of PET Europe at Curium, commented:“Acceptance of Swissmedic’s application for marketing approval of Pill Clari”® This is another important milestone for prostate cancer patients in Switzerland. We look forward to improving the selection of tools available to physicians for diagnosing patients with prostate cancer. The key is when PYLCLARI is fully operational.® expected to be the most widely available 18European F-PSMA tracer. ”
The submission by beimaging AG to Swissmedic was based on the marketing authorization application for Curium (18F)-DCFPyL will be submitted to the European Medicines Agency in July 2022. Approval for manufacturing and sales of Pill Clari® (Also known as (18F)-DCFPyL) was authorized by the European Commission in July 2023.
beimaging AG currently distributes Curium's entire suite of SPECT imaging products throughout Switzerland and has exclusive distribution rights for PYLCLARI.® Swiss. Once approval is obtained, PYLCLARI® Sourced from Curium's three European facilities.
Click here for more information about Pill Clari®: https://pylclari.com
In the United States, Lantheus has received the following approvals: [18F]-DCFPyL, now PYLARIFY® (Pifluforastat F 18 Injection) was approved by the Food and Drug Administration (FDA) in May 2021. This is the #1 PSMA PET imaging agent on the US market. European rights were licensed by Curium from Lantheus Progenics in 2018.
About Curium
Curium is a world leader in nuclear medicine. We develop, manufacture and market world-class radiopharmaceutical products to help patients around the world. Our proven tradition, combined with a pioneering approach, is the hallmark of innovation, excellence and unparalleled service.
With manufacturing facilities in Europe and the United States, Curium provides SPECT, PET, and therapeutic radiopharmaceutical solutions for life-threatening diseases to more than 14 million patients annually. The name “Curium'' honors the work of pioneering radioactive researchers Marie and Pierre Curie, is named after the radioactive element curium, and emphasizes our focus on nuclear medicine. . For more information, please visit www.curiumpharma.com.
For more information:
ross bethel
Vice President, Head of Global Communications
communication@curiumpharma.com
About B Imaging AG
beimaging is a Swiss affiliate of the Bender Group (www.bendergruppe.com). The Bender Group is a family-owned pharmaceutical wholesaler that manufactures contrast media and radiopharmaceuticals in Germany, Austria, France and Switzerland. Focused on radiology and nuclear medicine, his solutions include proprietary software, as well as general contrast agents, medical devices, and medical education programs. With more than 160 employees, we are fully committed to the needs of radiology and nuclear medicine from an imaging and treatment perspective.
