MELBOURNE, Australia and LIÈGE, Belgium, March 29, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has signed an exclusive agreement with Xiel Limited (Xiel) for the distribution of Telix's prostate cancer investigational imaging product, Illuccix® (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11 injection) in the United Kingdom (U.K.) and the Republic of Ireland.
Under the terms of the agreement, Xiel, a specialist distributor of Nuclear Medicine, Radiotherapy and Diagnostic Radiology technologies across the U.K. and Ireland will be the exclusive commercial distributor of Illuccix in the U.K. (a top 5 European market by GDP) and the Republic of Ireland for a period of three years from the national approval date.
Xiel Managing Director, Jack Knight stated, "PSMA PET imaging is emerging as the standard of care having recently been included in European1 and U.S.2,3 clinical practice guidelines. We are delighted to be adding Illuccix® to our nuclear medicine portfolio and look forward to bringing this product to British and Irish men in need, upon regulatory approval. This commercial partnership with Telix will enable us to open the door to state-of-the-art PSMA imaging for the 61,000 men diagnosed with prostate cancer each year in the U.K. and the Republic of Ireland."
Telix CEO EMEA, Richard Valeix added, "The U.K. and Republic of Ireland are one of Telix's largest potential markets within the EMEA region, so we are pleased to have secured this agreement in anticipation of regulatory approval. Telix is creating a network of leading distribution partners to ensure we have a strong footprint to optimise our service to customer sites and ensure we can bring our imaging agent to patients across the region."
Xiel replaces Curium as Telix's exclusive distribution partner in the U.K. and the Republic of Ireland.
About Prostate Cancer in the U.K. and Ireland
In 2020, prostate cancer was the most commonly diagnosed cancer in men in the U.K. and Ireland, with approximately 61,000 new cases being diagnosed, exhibiting a significantly higher incidence in men than either lung cancer (30,000 new cases) or bowel cancer (32,000 new cases). Prostate cancer was also a leading cause of cancer death in men, with almost 14,000 men dying from the disease in the U.K. and Ireland in 2020. 255,000 British and Irish men were estimated to be living with prostate cancer in 2020.4
About Xiel Limited
Xiel Ltd is a specialist distributor of medical technologies in the U.K. and Ireland, working with global leading solution providers to continuously improve efficiency and quality for customers. The team at Xiel has extensive experience in bringing innovative new products to the field of Nuclear Medicine and Oncology and has commercialised numerous diagnostic and therapeutic radiation products. Xiel, with its headquarters in Shepton Mallet (near Bristol), is particularly familiar with the range of UK clinicians and technologists in the prostate cancer space and is well placed to facilitate the adoption of innovative products by multi-disciplinary teams. The leadership group at Xiel has previously organised the successful U.K. launch of a market-leading theranostic combination of a gallium-based diagnostic and therapeutic molecular radiotherapy in the neuro-endocrine cancer market, and has expertise in the regulatory and reimbursement processes. For more information visit xiel.co.uk/.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation 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® (kit for preparation of gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),5 and by the Australian Therapeutic Goods Administration (TGA).6 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe7 and Canada.8
This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.
Legal Notices
This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.
The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
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1 |
European Association of Urology (EAU) Guidelines on Prostate Cancer. Limited Update March 2022. Available at: https://uroweb.org/guidelines/prostate-cancer. |
2 |
Trabulsi EJ et al. J Clin Oncol. Jan 2020. |
3 |
National Comprehensive Cancer Network (NCCN) Guidelines. Sep 2021. Available at: https://www.nccn.org/guidelines/category_1. |
4 |
Globocan 2021. |
5 |
ASX disclosure 20 December 2021. |
6 |
ASX disclosure 2 November 2021. |
7 |
ASX disclosure 10 December 2021. |
8 |
ASX disclosure 16 December 2020. |