MELBOURNE, Australia and LIÈGE, Belgium, Oct. 15, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) (“Telix”, the “Company”), 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.”
About Telix Pharmaceuticals
Telix Pharmaceuticals Limited (“Telix”) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (Japan) and Indianapolis (USA). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.
About ANMI SA
ANMI SA is a pharmaceutical company developing innovative solutions 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 and is a highly validated and promising target for a range of diagnostic and therapeutic strategies in prostate cancer.
About HBED-CC-PSMA-11 (68Ga-PSMA)
HBED-CC-PSMA-11 (68Ga-PSMA) is a small molecule (ligand) that targets and binds to PSMA and enables 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 the 68Ga-PSMA Kit (illumetTM )
ANMI’s 68Ga-PSMA kit is the first “cold kit” for direct labelling of a PSMA-targeting molecule with 68Ga (gallium). The kit utilizes proprietary chemistry to enable robust and reliable radiolabeling at room temperature in 5 minutes. The 68Ga-PSMA kit is currently in late-stage clinical development in Europe and is partnered in the US with Telix Pharmaceuticals where it is marked under the brand name illumetTM.
|Telix Corporate Contact||Telix Investor Relations (Australia)|
|Dr Christian Behrenbruch|
Telix Pharmaceuticals Limited
Tel: +61 (3) 9866 4722
|Telix Investor Relations (US)|
Tel: +1 212 452 2793
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the products described in this release have obtained a marketing authorization in any jurisdiction, including Japan.