Program relevance: TLX591-CDx (68Ga-PSMA-11) for the imaging of metastatic prostate cancer with positron emission tomography (PET)
Synopsis: Telix, via its wholly-owned subsidiary Advanced Nuclear Medicine Ingredients (ANMI) SA, had a successful scientific advisory meeting with the Danish Medicines Agency (DKMA) on the 19th of June. The purpose of the meeting was to review the suitability of the Company’s data package for TLX591-CDx (68Ga-PSMA-11) to support a European marketing authorisation application (MAA). The Company has now received the formal meeting minutes from the DKMA and is therefore able to reliably report the outcome of the consultation.
Key Points for Investors:
It is best practice to consult a referring EU Competent Authority in order to validate the non- clinical and clinical regulatory package for a medical product prior to submission of a marketing authorisation application (MAA).
The Danish Medicines Agency (DKMA) was specifically approached as a reference authority because of extensive expertise in reviewing medical imaging and radiopharmaceutical product submissions.
The DKMA indicated broad support for ANMI’s approach for the MAA and is willing to serve as a reference authority for the MAA process.
Detailed scientific advice from the DKMA validates the regulatory strategy for TLX591-CDx and clearly maps out the pathway for a “de-centralized” EU MAA submission.
Telix/ANMI expects to complete the indicated requirements for the MAA submission in the next 6 months.
Telix Pharmaceuticals Reports Positive Consultation for European Approval of Prostate Imaging Agent
Melbourne (Australia) and Liège (Belgium) – 22 July 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) has today announced that it has formalised the documented outcomes of a scientific advisory meeting held with the Danish Medicines Agency (DKMA) on the 19th of June.
Telix, through its wholly owned subsidiary ANMI SA (“ANMI”), has developed a 68Ga-PSMA-11 cold kit (TLX591-CDx, branded as illumetTM in the United States) in conformance with EU guidelines (CPMP/EWP/1119/98/Rev.1) for the development of radiopharmaceutical products and diagnostic agents. As part of the preparation for a marketing authorisation in Europe, ANMI has successfully consulted with the DKMA as a reference Competent Authority in order to ascertain the suitability of the nonclinical and clinical studies to support a product approval in Europe.
The key outcomes from the DKMA scientific consultation relate to three major areas:
Non-clinical
The DKMA supported the dosing approach for TLX591-CDx.
The DKMA supported the rationale and extent of the product’s nonclinical package. Existing and planned studies were deemed adequate to support a marketing authorisation, pending assessment of the final data submission.
Clinical
The DKMA endorsed the suitability of the overall product strategy including human dosimetry and analysis of ANMI’s clinical efficacy data. The DKMA specifically agreed on the proposed surrogate Standard of Truth (SOT) to be used in the analysis of the ANMI clinical data set.
The DKMA agreed that ANMI’s approach to determining bioequivalence between kit and synthesiser-based preparation of 68Ga-PSMA-11 is reasonable and appropriate.
Regulatory
The DKMA agreed that the proposed submission package for TLX591-CDx cold kit fulfils the requirements for a Full-Mixed Marketing Authorisation Application (MAA) dossier.
The DKMA preliminarily agreed that a single MAA should be possible for the different kit configurations that are necessary to enable the use of the various manufacturers of 68Ga radiation sources or “generators” (ITM, Eckert & Ziegler and IRE) that have been validated with the product.
ANMI Managing Director Ludovic Wouters stated “We elected to engage with the DKMA as it has extensive expertise in radiopharmaceutical market approval review and serves as a useful benchmark Competent Authority for approval of our product in Europe. The detail and extent of the scientific advice is very timely and provides clear guidance on the pathway to attain an EU marketing authorisation, subject to review and approval of a complete submission.”
The final studies and analysis required to complete a submission for product approval are expected to take approximately six months. The DKMA scientific advice enables Telix (ANMI) to concurrently pursue European MAA in a timeline that is well aligned with the planned New Drug Application (NDA) submission of the illumetTM product in the United States.
Telix Group CEO Dr Christian Behrenbruch added, “The ANMI team have continued to deliver well against their corporate objectives since the acquisition of the company last December. Ludo and his team are to be commended for their efforts in moving along an EU MAA process in concert with the Telix USA team’s efforts with the US FDA.”
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 Liège (EU), Kyoto (JP) and Indianapolis (US). Advanced Nuclear Medicine Ingredients (ANMI) SA is a wholly-owned subsidiary of Telix that was acquired in December 2018. 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.