With the initial data suggesting a potential product, I thought...

With the initial data suggesting a potential product, I thought this may be interesting for advanced work up.
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Telix Pharmaceuticals and ANMI Partner for Prostate Cancer Imaging
October 23, 2017 19:00 ET | Source: Telix Pharmaceuticals Limited


MELBOURNE, Australia and LIÈGE, Belgium, Oct. 24, 2017 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (Telix, Company), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or molecularly-targeted radiation (MTR), is pleased to announce that it has entered into a development and commercialization partnership with Advanced Nuclear Medicine Ingredients SA (ANMI).

Under the terms of the agreement, Telix and ANMI will partner to commercialise ANMI’s 68Ga-HBED-CC-PSMA (68Ga-PSMA-11) kit (Kit), a proven technology used to accurately image and stage metastatic prostate cancer, in the US market. Telix will also offer the Kit on a worldwide basis as a companion diagnostic imaging agent to the Company’s prostate cancer therapeutic (TLX-591)1. The agreement includes filing a Drug Master File (DMF) for the Kit, and completion of the necessary clinical trials to obtain marketing authorisation from the US Food and Drug Administration (FDA).

68Ga-PSMA-11 is a proven technology solution for the accurate imaging and staging of metastatic prostate cancer. PSMA-11 (also known as DKFZ-112) is a small molecule that binds to prostate-specific membrane antigen (PSMA), a well-validated target that is highly expressed in both localised and metastatic prostate cancer, including castrate-resistant prostate cancer. PSMA-11 radiolabelled with 68Ga (gallium) is a convenient and clinically efficient approach to imaging prostate cancer with Positron Emission Tomography (PET). PSMA is also targeted by Telix to treat prostate cancer with 177Lu (lutetium).

Telix Co-Founder and CEO Dr. Christian Behrenbruch stated, “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. 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 Co-Founder and CEO Ludovic Wouters noted, “Prostate cancer affects one in eight men in the US3and the market opportunity is very significant. We are pleased to be working with Telix to deliver our solution to patients in the US.” ANMI Co-Founder and CSO Dr. Sam Voccia added, “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.”

As part of the implementation of the agreement, Telix and ANMI will establish a joint-venture (JV) company, with ANMI selling Kits to the JV on an exclusive basis for the US Market. Telix will be appointed as the sales and marketing partner to the JV, via the Company’s US subsidiary.