Telix and Cyclotek Enter into Manufacturing Partnership for Kidney Cancer Imaging

MELBOURNE, Australia, 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 an extension to its master service agreement (MSA) with Cyclotek (Aust) Pty Ltd  (“Cyclotek”) to include 89Zr-girentuximab (TLX250-CDx) for imaging patients with clear cell renal cell cancer (ccRCC) using Positron Emission Tomography (PET).

Telix has selected Cyclotek to manufacture and supply Australian clinical trial sites as well as serve as a part of Telix’s global production network as a backup site for the Company’s global multi-centre Phase III clinical trial. This extension of the MSA leverages Cyclotek’s extensive expertise in production scale-up of novel PET tracers and its leadership position in the Australian and New Zealand radiopharmaceutical manufacturing landscape. In addition to supporting clinical trials, the manufacturing partnership paves the way for the provision of TLX250-CDx to the regional market.

Telix CEO Dr Christian Behrenbruch stated, “The extension of our agreement with Cyclotek delivers another important component in Telix’s network for supply of TLX250 for our clinical trials and also creates a platform for commercialization of the product in the future. We value our partnership with Cyclotek for their experience in GMP manufacturing and their demonstrated ability to deliver high-quality product as an integrated part of international trials.”

Cyclotek Clinical Director Dr Rob Ware commented, “We are delighted to expand our relationship with Telix to assist with their objective of including several excellent Australian clinical trial sites in their roadmap to establish the clinical effectiveness of 89Zr-girentuximab for the imaging of metastatic kidney cancer. This development aligns with our core belief in the potential of molecularly targeted radiation (MTR) to improve healthcare outcomes for cancer patients, both diagnostically and therapeutically.”

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 (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).

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About Cyclotek (Aust) Pty Ltd

Cyclotek has been a leading manufacturer and supplier of Positron Emission Tomography (PET) radiopharmaceuticals since 2001. Cyclotek currently operates four manufacturing facilities in Australia and New Zealand and is rapidly expanding its facilities to meet the demands for the manufacture of diverse range of diagnostic and therapeutic radiopharmaceuticals. Cyclotek’s facilities are licensed by the Australian Therapeutic Goods Administration (TGA) to manufacture medicines according to the Code of Good Manufacturing Practice (GMP).

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Important Information

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 Australia.