Telix to Supply Bayer with Illuccix® for Global Phase III Prostate Cancer Study

MELBOURNE, Australia, May 8, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix^® (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection)^[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT^[2] at baseline.

The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.

Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool."

About Bayer AG

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

About darolutamide

Darolutamide is an oral ARi with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

The product is approved under the brand name Nubeqa™ in more than 80 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in a number of markets including the U.S., Japan, China and the EU. The compound is also being investigated in further studies across various stages of prostate cancer.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn.

About Illuccix^®

Telix's lead product, Illuccix^® (gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),^[3] and by the Australian Therapeutic Goods Administration (TGA),^[4] and by Health Canada.^[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.^[6]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com

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