Curium announces first commercial doses in Italy of PYLCLARI® – an innovative 18F-PSMA PET tracer indicated in patients with prostate cancer

(Paris, France – March 7, 2024) – Curium, a world leader in nuclear medicine, announced today that the first commercial doses of PYLCLARI® have been sold in Italy. PYLCLARI® (INN: Piflufolastat (¹⁸F)) also known as (¹⁸ F)-DCFPyL, is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients 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

Benoit Woessmer, PET Europe CEO at Curium commented, “We are thrilled that we have successfully started the commercial supply of PYLCLARI® in Italy – supporting even more nuclear medicine physicians and their patients across Europe. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, today’s announcement underscores our priority on improving the choice of diagnostic modalities available to our customers – ultimately for the benefit of patients with prostate cancer.”

In Italy, Curium currently manufactures PYLCLARI® at its facilities in Milan, with plans to expand production to Pisa and Rome in the future to enable more patients to benefit.

Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI® in the European Union. On 3^rd February 2024 The Italian Medicines Agency (Agenzia Italiana del Farmaco) published the decision for PYLCLARI® in Italy.

For more information about PYLCLARI®:  www.pylclari.com

In the U.S., Lantheus received approval for [18F]-DCFPyL, now PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 utilized PSMA PET Imaging Agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.