Australia’s Telix Pharmaceuticals has entered a partnership with Belgium’s Advanced Nuclear Medicine Ingredients (ANMI) to commercialize ANMI’s 68Ga-HBED-CC-PSMA (68Ga-PSMA-11) kit, used for prostate cancer imaging, in the United States.
“Prostate cancer affects one in eight men in the U.S. and the market opportunity is very significant,” ANMI co-founder and CEO Ludovic Wouters said in a press release. “We are pleased to be working with Telix to deliver our solution to patients in the U.S.”
ANMI’s 68Ga-PSMA-11 kit is composed of a small molecule, called PSMA-11, that binds to the prostate-specific membrane antigen (PSMA). PSMA is found in all types of prostatic tissues, but is more prevalent in metastatic prostate cancer, including castrate-resistant prostate cancer.
The PSMA-11 in ANMI’s kit is attached to 68Ga (gallium), a radioactive chemical element that positron emission tomography (PET) scans can detect, providing improved spatial resolution and easier quantitation.
As a result, the 68Ga-PSMA-11 kit allows for a better imaging of the patients’ primary tumor and metastasis.
“ANMI’s ‘shake and inject’ kit allows for the rapid, room-temperature labelling of the PSMA-11 ligand with gallium. This has become a well-proven approach for imaging prostate cancer and ANMI’s technology makes the process extremely efficient in the clinical setting,” said Telix’s co-founder and CEO, Dr. Christian Behrenbruch. “ANMI’s radiochemists are the best and brightest in the industry and we are pleased to be working with the team to tackle prostate cancer.”
ANMI’s partnership with Telix will also allow the kit to be commercialized on a worldwide basis as a companion diagnostic imaging agent to the Telix’s prostate cancer therapeutic (TLX- 591). This is an anti-PSMA antibody bound to a radioactive agent, Lutetium-177 (177Lu). After binding to PSMA, the antibody delivers the payload to cancer cells, killing them.
As part of the agreement, the companies will have to fill the kits’ Drug Master File, and complete the necessary clinical trials to receive marketing authorization from the U.S. Food and Drug Administration.
“Telix is building a portfolio of diagnostic and therapeutic urology products that we believe will help to drive physician interest and market share for our products,” said Dr. Sam Voccia, ANMI’s co-founder and chief scientific officer.
Both companies will establish a joint-venture entity that allows ANMI to sell kits on an exclusive basis for the U.S. market; Telix will be the sales and marketing partner.