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Isotopia Launches Isoprotrace for Prostate Cancer Imaging in Germany Through DSD Pharma Partnership

  • Isotopia has officially launched Isoprotrace®, a radiopharmaceutical for prostate cancer imaging, in Germany through an exclusive partnership with distributor DSD Pharma.

  • Isoprotrace® is a multi-dose kit for preparing Gallium-68 Gozetotide solution, indicated for PET imaging of PSMA-positive lesions in high-risk prostate cancer staging and suspected recurrence cases.

  • The product has already been approved in the Netherlands and is expected to be available in over 10 EU countries, addressing a significant need in Germany where over 70,000 new prostate cancer cases are diagnosed annually.

Isotopia, a leading developer of radiopharmaceuticals, has officially launched Isoprotrace® in Germany through an exclusive partnership with pharmaceutical distributor DSD Pharma. The collaboration ensures efficient delivery of this innovative prostate cancer imaging agent to hospitals, clinics, and diagnostic centers throughout Germany.
The partnership also includes distribution of Isotopia's Lutetium (177Lu) Chloride n.c.a., expanding their portfolio of advanced cancer imaging and treatment solutions in the German market.

Advanced Imaging Solution for Prostate Cancer

Isoprotrace® is a cutting-edge radiopharmaceutical designed specifically for prostate cancer imaging. The multi-dose kit enables rapid and efficient preparation of Gallium (68Ga) Gozetotide solution for intravenous injection. After radiolabeling with gallium (68Ga) chloride solution, the product is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions.
The imaging agent is indicated for two primary clinical applications:
  • Primary staging of patients with high-risk prostate cancer prior to primary curative therapy
  • Detection of suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels after primary curative therapy
This launch addresses a significant medical need in Germany, where prostate cancer remains one of the most common cancers among men with over 70,000 new cases diagnosed annually. Accurate imaging plays a crucial role in precise diagnosis and effective treatment planning for these patients.

Strategic Partnership for Market Access

Tzachi Levy, General Manager of Isotopia's aseptic plant, emphasized the strategic importance of the German market: "We are thrilled to be working with DSD Pharma to bring Isoprotrace® to the German market. Germany is a key market for Isoprotrace®, and we are confident that this collaboration will ensure the successful introduction and accessibility of this innovative product to healthcare providers across the country."
DSD Pharma, which operates across Austria, Germany, and Switzerland, will leverage its established distribution network to ensure consistent delivery of Isoprotrace® throughout Germany.
Dr. Susanne Dorudi, Managing Director at DSD Pharma, expressed enthusiasm about the partnership: "We are proud to partner with Isotopia to introduce Isoprotrace® to Germany. This collaboration allows us to offer German healthcare professionals a groundbreaking imaging solution. We are excited about the potential impact of this product and look forward to its success in the German market."

European Expansion Plans

Isoprotrace® has already received regulatory approval in the Netherlands and is expected to be available soon in over 10 European Union countries. Isotopia reports having established a robust and reliable supply chain with a proven compliance record.
The company states it is committed to expanding patient access to this innovative product while enhancing diagnostic accuracy and improving treatment outcomes for prostate cancer patients across Europe.

Advancing Precision Medicine in Oncology

This commercial launch represents another step forward in the field of precision medicine for oncology. Advanced imaging techniques like PSMA-PET using radiopharmaceuticals such as Isoprotrace® allow for more accurate detection of prostate cancer lesions compared to conventional imaging methods.
The ability to precisely locate PSMA-positive lesions helps clinicians make more informed decisions about treatment strategies, potentially improving patient outcomes through more targeted interventions.
As molecular imaging continues to evolve, partnerships like the one between Isotopia and DSD Pharma play a crucial role in bringing these advanced diagnostic tools to clinical practice, ultimately benefiting patients with prostate cancer who require accurate staging and recurrence monitoring.
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