Telix and NUCLIBER Sign Distribution Agreement for Prostate Cancer Imaging in Spain

MELBOURNE, Australia and MADRID, Spain, Dec. 07, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an exclusive commercial distribution agreement with Madrid-based NUCLIBER S.A. Spain (NUCLIBER) for Telix’s prostate cancer investigational imaging product Illuccix^® (Kit for the preparation of ⁶⁸Ga-PSMA-11 injection) for the Spanish market.

Under the terms of the agreement, and subject to closing requirements being satisfied, NUCLIBER will be the overall distributor and local representative for Illuccix in Spain, an EU5 country, from the national approval date. NUCLIBER has demonstrated experience in the supply of gallium generators across Spain and has been selected according to its ability to deliver a secure and continuous supply of ⁶⁸Ga necessary for commercial launch in the country.

NUCLIBER Managing Director, Marisol Fornes stated, “We are delighted to be working with Telix and adding the Company’s lead investigational asset to our future nuclear medicine offering in Spain. With recent updates to European¹ and U.S.^2,3 clinical practice guidelines, PSMA-PET is emerging as the standard of care for prostate cancer imaging worldwide. Through this commercial partnership we will support Telix in pursuit of its goal to provide widespread access to state-of-the-art diagnostic imaging for Spanish men living with prostate cancer following marketing authorisation in Spain.”

Telix EMEA President Richard Valeix added, “NUCLIBER is a leading nuclear medicine company in Spain, and we are therefore pleased to have entered into this commercial distribution agreement as we prepare for the European launch of Illuccix. Collaborating with such an established and patient-centric leader in radiopharmaceuticals will help Telix to deliver on the promise of nuclear medicine with the ultimate aim to improve outcomes for Spanish men living with prostate cancer.”

About Prostate Cancer in Spain

In 2020, prostate cancer was the most commonly diagnosed cancer in men in Spain, with approximately 34,600 new cases being diagnosed, exhibiting a significantly higher incidence in men than either lung cancer (21,500 new cases) or bowel cancer (24,600 new cases). Prostate cancer was also a leading cause of cancer death in men, with almost 5,800 men dying from the disease in Spain in 2020. Almost 137,000 Spanish men were estimated to be living with prostate cancer in 2020.⁴

About NUCLIBER

NUCLIBER was founded in 1962 as a company designing and manufacturing equipment for various applications in industry using ionizing radiation. NUCLIBER pioneered the supply of radioisotopes in Spain in the industrial, medical and research fields. Today NUCLIBER is focused on nuclear medicine, oncology, and non-destructive testing, offering a wide range of products. NUCLIBER was founded with a vocation for service and quality. The same vocation exists today. For more information visit: https://www.NUCLIBER.es/

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix’s lead product, Illuccix (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA),⁵ and accepted for filing by the U.S. FDA.⁶ Telix is also progressing marketing authorisation applications for Illuccix in the European Union⁷ and Canada.⁸

With the exception of Illuccix in Australia, none of Telix’s products have received a marketing authorisation in any jurisdiction. In Brazil, Illuccix has been granted exceptional authorisation.⁹

Telix Media Contact

Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
Email: stewart.holmstrom@telixpharma.com

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 “U.S. 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 U.S. Securities Act or an exemption from the registration requirements of the U.S. Securities Act is available. With the exception of Illuccix in Australia, none of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

¹ European Association of Urology 2020.
² Trabulsi EJ et al. J Clin Oncol. Jan 2020.
³ National Comprehensive Cancer Network (NCCN) Guidelines. Sep 2021.
⁴ Globocan 2021.
⁵ ASX disclosure 02/11/21.
⁶ ASX disclosure 24/11/20.
⁷ ASX disclosure 01/05/20.
⁸ ASX disclosure 16/12/20.
⁹ ASX disclosure 01/12/21.