Program relevance
TLX591-CDx (68Ga-PSMA) for the imaging of prostate cancer with positron emission tomography (PET). Branded as illumetTM in the US market.
Synopsis:
Telix continues to make considerable progress with the development of the illumetTM (kit for the preparation of 68Ga-PSMA) product in the US market. In this brief update, the company reports that it has submitted a request to the United States Food and Drug Administration (FDA) for a pre-New Drug Application (NDA) meeting. An NDA is the process by which a company applies for a marketing approval for a pharmaceutical product in the US. In addition, Telix has also added two excellent partners in the US – United Pharmacy Partners Inc. (UPPI) and PharmaLogic – rounding out the Company’s product distribution network in preparation for full commercialisation.
Key Points for Investors:
Telix has formally commenced the process of engaging with the FDA to apply for a marketing authorization for the illumetTM prostate cancer imaging product in the United States. The Company’s NDA activity builds on the prior submission of a Drug Master File (DMF) and multiple clinical studies in the USA and Europe.
The addition of UPPI and PharmaLogic to Telix’s existing distribution partner, Cardinal Health, further extends the partnering options for the company and maximises Telix’s product distribution reach in the United States, pending a marketing authorization (subject to FDA approval).
Melbourne (Australia) and Indianapolis (USA) – 28 May 2019. 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 provides an update on the progress of its prostate cancer imaging product, branded as illumetTM (kit for the preparation of 68Ga-PSMA) in the United States.
IllumetTM Regulatory Update The Company has now submitted a pre-New Drug Application (NDA) meeting request to the US Food and Drug Administration. The company has prepared a comprehensive pre-NDA package and expects to have a meeting with the FDA in July to determine the go/no-go status of a submission for a marketing authorization in the United States. The NDA process builds on the Drug Master File (DMF) that the Company submitted in July of last year. Since then, multiple Investigational New Drug (IND) applications have referenced Telix’s DMF, including the Endocyte (now Novartis) VISION Phase III trial and several important academic studies that are building clinical experience and exploring new application areas for the product in the US market.
Additional illumetTM Distribution Partners Telix has completed a distribution agreement with United Pharmacy Partners Inc. (UPPI) for the illumetTM product. UPPI and its network of nuclear pharmacies provide national coverage for both regional cancer centres as well as large Group Purchasing Organizations (GPOs). The Company has also completed a distribution agreement with PharmaLogic, a network of radiopharmacies and nuclear medicine imaging services located predominantly in the Northeast and Western United States. Telix Pharmaceuticals (USA) President, Dr. Bernard Lambert stated, “We continue to make excellent progress with the development of illumet TM, including building the commercial delivery platform for the product. The addition of PahrmaLogic and UPPI to our existing distribution activity further extends our reach in the US market."
About Telix Pharmaceuticals Limited
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 (JP) and Indianapolis (US). 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.