Curium receives marketing authorization in Switzerland for PYLCLARI® – an innovative 18F-PSMA PET tracer indicated in patients with prostate cancer

• Swissmedic grants marketing authorization for PYLCLARI^® in Switzerland
• b.e. Imaging is marketing authorization holder and has exclusive distribution rights for PYLCLARI^® across Switzerland

ZURICH, May 12, 2025 (GLOBE NEWSWIRE) -- Curium announced today that it has marketing authorization in Switzerland for the distribution of PYLCLARI^® (INN: Piflufolastat (¹⁸F) formerly known as (¹⁸F)-DCFPyL). PYLCLARI^® is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer in the following clinical settings:

• Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
• To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI^® in the European Union. b.e. Imaging currently distributes Curium’s entire suite of SPECT radiopharmaceuticals across Switzerland and following an exclusive distribution rights agreement in September 2023, will now also distribute PYLCLARI^®.

Dr. Michel Wuillemin, Managing Director at b.e. Imaging commented, "b.e. Imaging has proven to be a crucial supplier for the whole range of Curium’s SPECT radiopharmaceuticals for Switzerland. The extension of the partnership with Curium to PSMA PET imaging with PYLCLARI^® underscores b.e. Imaging’s focus in the field of prostate cancer. Curium’s PYLCLARI^® is in line with b.e. Imaging’s experience in the field of radioligand therapy for patients with prostate cancer.”

Benoit Woessmer, PET Europe CEO at Curium commented, "We are pleased with the growing availability of PYLCLARI^® to reach more nuclear medicine physicians and their patients across Europe. With today’s announcement, we are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to our customers in Switzerland – ultimately for the benefit of patients with prostate cancer.”

In Switzerland, prostate cancer is the most common cancer among men with around 7,800 new cases diagnosed nationwide every year. Today’s announcement is part of the continued roll-out of PYLCLARI^® across the European Union, which with the addition of Switzerland, is now available for patients with prostate cancer in 12 countries. In the U.S., Lantheus received approval for PYLARIFY^® (Piflufolastat (¹⁸F) Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET agent in the U.S. market. The European rights were licensed to Curium from Progenics, a Lantheus company, in 2018.

About b.e. Imaging AG
b.e. Imaging is the Swiss affiliate of the bender group (www.bendergruppe.com). The bender group is a family-owned pharmaceutical wholesaler and producer for contrast media and radiopharmaceuticals in Germany, Austria, France and Switzerland. Its focus on radiology and nuclear medicine includes their own developed software solutions as well as generic contrast media, medical devices, and medical education programs. With more than 160 employees we are fully dedicated to the needs of radiology and nuclear medicine in terms of imaging and therapy.

About Curium
Curium is a world leader in nuclear medicine with global headquarters in Paris, France. 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:
communications@curiumpharma.com