On October 26, 2011 ATLAB Pharma and BZL Biologics entered into a sublicense agreement to develop 177Lu-J591 for cancer treatment (Press release ATLAB Pharma, OCT 28, 2011, View Source [SID:1234500930]). The agreement includes exclusive rights to manufacture, develop and commercialize this radiopharmaceutical product worldwide as well as a joint Phase IIB/III clinical validation program.
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177Lu-J591 has shown a highly attractive efficacy and tolerability profile in phase I and Phase II trials involving 108 patients with metastatic castrate-resistant prostate cancer (M+ CRPC). A large randomized multicenter Phase IIB study is ongoing in CRPC patients with rising PSA but no detectable metastasis (M0 CRPC), a clinical condition affecting more than a million men worldwide, for whom there is no approved therapy.
According to the agreement, ATLAB Pharma will fund certain product development and clinical trials.
Dr. Jean-Marc Le Doussal, President of ATLAB Pharma, stated that "177Lu-J591 has a very good therapeutic profile in metastatic prostate cancer patients, validated by several clinical trials and an exceptional scientific rationale. 177Lu-J591 has a large market potential in CRPC patients and beyond. We are very happy to join forces with BZL to hasten the development of this unique drug."
"Our partner BZL shares our vision that targeted radiotherapy drugs have the unique ability to eradicate micro-metastatic disease at an early stage of cancer progression. We believe that current trials will confirm the 177Lu-J591 survival benefit at the micro-metastatic stage of castrate resistant prostate cancer progression" added Dr. Jean-Francois Chatal, Emeritus Professor of Nuclear Medicine and Chief Medical Director at ATLAB Pharma.