Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Telix Pharmaceuticals Ltd Capital/Financing Update 2021

Sep 12, 2021

31324_rns_2021-09-12_c21468d1-c5d5-4ab9-81dc-930bf8298339.pdf

Capital/Financing Update

Open in viewer

Opens in your device viewer

Telix Pharmaceuticals Limited ACN 616 620 369 Suite 401, 55 Flemington Road North Melbourne Victoria, 3051 Australia

==> picture [146 x 81] intentionally omitted <==

Telix and Radius Sign Italian Distribution Agreement for Prostate Cancer Imaging

Melbourne (Australia) and Bologna (Italy) – 13 September 2021 . Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an exclusive commercial distribution agreement with Bologna-based RADIUS S.r.l. (Radius) for Telix’s prostate cancer investigational imaging product Illuccix[®] (Kit for the preparation of[68] Ga-PSMA-11 injection) for the Italian market. This agreement builds on the support Radius has provided Telix in distributing[68] GaPSMA-11 for magisterial use in Italy.

Under the terms of the agreement, Radius will be the exclusive commercial distributor of Illuccix[®] in Italy, an EU5 country, for a period of three years from the national approval date. Radius is the market leader in the supply of gallium generators across Italy, a position which enables Radius to provide a secure supply of the[68] Ga necessary for launching Illuccix[®] . Radius also has the advantage of being a supplier and service provider for cyclotrons and radiotherapy suites across Italy.

Radius CEO, Dr. Mauro Mei stated, “This commercial partnership with Telix will enable us to open the door to state-of-the-art PSMA imaging for the 39,000 men diagnosed with prostate cancer each year in Italy. Given that PSMA imaging represents the latest standard of care for prostate cancer imaging, having recently been included in European[1] and U.S.[2] clinical practice guidelines, we are delighted to be adding Illuccix[®] to our nuclear medicine portfolio and look forward to bringing this product to Italian men in need, upon receipt of regulatory approval.”

Telix EMEA President Richard Valeix added, “As we prepare for the European launch of Illuccix[®] we are pleased to have entered into this agreement with Radius. Italy is an important market and we look forward to working with Radius to bring this highly anticipated imaging agent to Italian men, living with prostate cancer, once regulatory approval is received. Partnering with such a capable and patient-centric leader in nuclear medicine aligns with Telix’s mission of helping patients with cancer live longer, better quality lives.”

About Prostate Cancer in Italy

In 2020, prostate cancer was the most commonly diagnosed cancer in men in Italy, with approximately 39,000 new cases being diagnosed, exhibiting a significantly higher incidence in men than either lung cancer (28,000 new cases) or bowel cancer (26,000 new cases). Prostate cancer was also a leading cause of cancer death in men, with almost 7,000 men dying from the disease in Italy in 2020. Almost 150,000 Italian men were estimated to be living with prostate cancer in 2020.[3]

About Radius S.r.l.

Founded in 2003, Radius deals with innovative and state of the art solutions and technology in Italy, with exclusivity, for three main areas: Nuclear Medicine, Radiotherapy and Preclinical Research. With its headquarters in Budrio (in the vicinity of Bologna), Radius has two operative units, one in Roma at Policlinico Gemelli and one in Negrar (Verona) at Ospedale Sacro Cuore where technical assistance is provided to the ACSI TR 19 PET Cyclotrons installed at that site (since 2005 and 2013 respectively). Among its other products, Radius is the leading company in Italy for distribution of

1 European Association of Urology 2020.

2 Trabulsi EJ et al. J Clin Oncol. Jan 2020. 3 Globocan 2020.

Page 1

Eckert & Ziegler’s[68] Ga Generator, GalliaPharm[®] (which will be used with Illuccix[®] ). For more information visit www.radiustech.it

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, 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 investigational product, Illuccix[®] (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,[4] and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).[5] Telix is also progressing marketing authorisation applications for Illuccix[®] in the European Union[6] and Canada.[7] None of Telix’s products have received a marketing authorisation in any jurisdiction.

Telix Investor Relations

Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: [email protected]

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. 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.

4 ASX disclosure 24/11/20.

5 ASX disclosure 14/04/21.

6 ASX disclosure 1/05/20.

7 ASX disclosure 16/12/20.

Page 2