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 US3 and 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.
About Telix Pharmaceuticals Limited
Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or molecularly-targeted radiation (MTR). The Company is developing an advanced portfolio of oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. For more information visit www.telixpharma.com.
About ANMI SA
ANMI SA is a precursor supplier for radiometal labelled radiopharmaceuticals and a global service provider in the nuclear medicine field, located in Liège, Belgium. ANMI has developed innovative solutions to facilitate the scalable synthesis of “theranostic” radiopharmaceuticals and to ease their daily production in hospitals. ANMI's vision is focused on increasing patient access to new highly specific theranostic radiopharmaceuticals through streamlined and cost-effective production processes. For more information visit www.anmi.be
About Prostate-Specific Membrane Antigen (PSMA)
PSMA is a cancer target (cell surface antigen) that is highly upregulated in prostate cancer cells but has relatively little presence in normal tissues. PSMA is a highly validated and promising target for a range of diagnostic and therapeutic strategies in prostate cancer.
About PSMA-11
PSMA-11 is a small molecule (ligand) that targets and binds to PSMA. When radiolabelled with an isotope such as 68Ga (gallium), metastatic prostate cancer can be imaged using Positron Emission Tomography (PET) with excellent sensitivity and specificity. PET is a highly effective and widely used imaging modality in the management of cancer.
About ANMI’s PSMA-11 kit
ANMI’s PSMA-11 kit is the first kit for direct labelling of a PSMA-targeting molecule with 68Ga. The kit utilises proprietary chemistry to enable robust and reliable radiolabelling at room temperature in less than 5 minutes. ANMI’s PSMA-11 kit is currently under clinical development in Europe.4
1 Either directly with ANMI or in cooperation with ANMI’s network of global distribution partners
2 J Nucl Med 2017; 58:67S–76S - DOI: 10.2967/jnumed.116.186767
3 Prostate Cancer Foundation (PCT): https://www.pcf.org/c/about-the-prostate-cancer-foundation/
4 None of ANMI or Telix’s products currently have marketing authorization in the US, EU or any other territory.