Telix Further Strengthens European Distribution Network for Illuccix

MELBOURNE, Australia and LIÈGE, Belgium, April 22, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces agreements with Sociedade Avanço, Unipessoal, LDA (Avanço) and THP Medical Products Vertriebs GmbH (THP) for the distribution of Telix's prostate cancer investigational imaging product Illuccix® (Kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as PSMA-11) injection) for the Portuguese and Austrian, Czech Republic and Slovak Republic markets, respectively.

Under the terms of the new agreement in Portugal, Avanço, a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products, will be the exclusive commercial distributor of Illuccix in the Portuguese market for a period of three years from the national approval date.

In Austria, the Czech Republic and the Slovak Republic, this new agreement builds on the support THP, a specialist distributor of nuclear medicine products, has provided Telix in distributing ⁶⁸Ga-PSMA-11 for magisterial use since December 2015. Under the terms of the new agreement, THP will be the exclusive commercial distributor of Illuccix for a period of five years from national approval.

The signing of these agreements coincides with a recent update to the European Association of Urology (EAU) 'Guidelines on Prostate Cancer', which demonstrates an increasing recognition of the clinical utility of prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging modalities (PSMA PET), including gallium-68 PSMA-11, in the diagnosis of prostate cancer.^[1]

Telix CEO EMEA, Richard Valeix added, "Telix is building an extensive distribution network across Europe, with high quality partners with a strong reputation and radiopharmaceutical experience. We are pleased to welcome Avanço and further reinforce our strong collaboration with THP for the Portuguese and Austrian, Czech Republic and Slovak Republic markets, respectively, as we prepare for the European launch of Illuccix. These are important markets for Telix and, with PSMA-PET imaging emerging as a standard of care having recently been included in latest European^[1] and U.S.^[2],[3] clinical practice guidelines, we look forward to bringing this product to men in need, upon receipt of regulatory approval."

Telix now has European commercial distribution agreements in place in France (IRE ELiT), Germany (Eckert & Ziegler Strahlen- und Medizintechnik AG), Italy (Radius R.r.l) Spain (NUCLIBER S.A.), and the UK and Ireland (Xiel Limited), (all EU5 countries), plus Austria, Slovak Republic and Czech Republic (THP), Greece and Cyprus (BIOKOSMOS S.A.), Poland (Synektik Pharma Sp. Zo. o), Portugal (Avanço), Sweden, Denmark, Finland and Norway (all S Ahlén Medical Nordic AB).

About Sociedade Avanço

Avanço is a company focused on the commercialisation of advanced diagnostic and therapy solutions dedicated to cancer care. Avanço works closely with its clients to provide the best solutions matching their needs and this agreement represents a milestone in the strengthening of its portfolio, by improving access to this very important diagnostic modality.

About THP Medical Products

THP is a distributor of radiopharmaceuticals and life science research products, founded in 2000 and based in Vienna. Expertise and commitment to outstanding service and customer relations has led THP to become a significant player in the nuclear medicine market in Austria. 

THP's pharmaceutical representatives/product specialists support nuclear medicine departments in Austria, Slovakia and the Czech Republic as well as referring physicians (e.g. radiologists, oncologists, hepatologists, haematologists, urologists and neurologists). In addition to selling products, one of THP's goals is to be a reliable and high-quality service provider for customers and business partners. In order to offer competent advice in medical, technical and logistical matters, THP requires top personnel and continuous education and training.

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^[1] and follow Telix on Twitter^[2] (@TelixPharma) and LinkedIn^[3].

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),^[4] and by the Australian Therapeutic Goods Administration (TGA).^[5] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[6] and Canada.^[7]

Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[4]

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

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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.  

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[1] European Association of Urology (EAU) Guidelines on Prostate Cancer. Limited Update Mar 2022. Available at: https://uroweb.org/guidelines/prostate-cancer^[5].

[2] Trabulsi EJ et al. J Clin Oncol. Jan 2020.

[3] National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) Sep 2021. Available at: https://www.nccn.org/guidelines/category_1^[6].

[4] ASX disclosure 20 December 2021.

[5] ASX disclosure 2 November 2021.

[6] ASX disclosure 10 December 2021.

[7] ASX disclosure 16 December 2020.

References

1. ^{^} www.telixpharma.com (www.telixpharma.com)
2. ^{^} Twitter (twitter.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)
5. ^{^} https://uroweb.org/guidelines/prostate-cancer (uroweb.org)
6. ^{^} https://www.nccn.org/guidelines/category_1 (www.nccn.org)