Monday, October 15, 2018
Telix Pharmaceuticals Limited, a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR), today announced that it has expanded its partnership with Advanced Nuclear Medicine Ingredients SA (“ANMI”) for the 68Ga-HBED-CC-PSMA-11 (68Ga-PSMA) cold kit. The 68Ga-PSMA kit is developed by ANMI and commercialized by Telix for the US market where it is marketed as illumetTM.
In response to considerable clinical interest in the illumetTM product, Telix has commenced scale-up manufacturing in the United States, following the recent filing of a drug master file (DMF) and the launch of several major clinical trials using the product, including the 750 patient VISION phase III trial (Endocyte, Inc.) and a 500-patient phase II study at Memorial Sloan Kettering Cancer Center in New York (MSKCC). Large-scale GMP manufacturing of the illumetTM product is a significant milestone toward the Company’s objective of achieving a New Drug Application (NDA) for 68Ga-PSMA in the United States. Under the terms of the expanded relationship, Telix will sell US-manufactured product to ANMI for labeling and distribution outside of the United States.
Telix CEO Dr. Christian Behrenbruch stated, “There is enormous clinical interest in 68Ga-PSMA imaging, globally, reflective of the considerable market opportunity and clinical unmet need for sensitive and specific prostate imaging with PET. This additional agreement with ANMI represents a further near-term revenue opportunity for Telix and enables us to improve our production economics by supporting ANMI’s clinical trials and future commercialization outside of the United States.”
ANMI Co-Founder and CEO Ludovic Wouters noted, “We are very pleased to be working with Telix to boost production capacity to meet our needs for both clinical trials and future sales. Given the growing international popularity of 68Ga-PSMA, scale-up manufacturing is critical requirement for the future success of the product.”
