Telix Pharmaceuticals and Eczacibasi-Monrol Sign Manufacturing and Distribution Agreement

MELBOURNE, Australia and ISTANBUL, Turkey, June 13, 2019 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX.TLX) ("Telix”, the "Company”), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation” (MTR) has today announced that it has concluded a master services and distribution agreement with Eczacibasi-Monrol.

Under the terms of the agreement, Telix has appointed Eczacibasi-Monrol as a radiopharmaceutical production partner and distributor in Turkey/Middle East/North Africa. Eczacibasi-Monrol is commercially active in more than 40 countries, including important growth territories that complement Telix’s current commercial strategy for the US and Europe. The parties will initially focus on the production and distribution of TLX250-CDx (⁸⁹Zr-girentuximab) for imaging of renal cell carcinoma with Positron Emission Tomography (PET), including to support the addition of four (4) Turkish clinical sites to the ZIRCON Phase III trial.

Telix Pharmaceuticals co-founder and CEO, Dr. Christian Behrenbruch stated, "Eczacibasi-Monrol is an important nuclear medicine company in the countries in which they operate, providing critical nuclear medicine products and services. Through our partnership with Eczacibasi-Monrol we are able to extend Telix’s reach into countries that have a rapidly developing need for our products as well as make use of Eczacibasi-Monrol’s technical strength within the Turkish production team.”

Telix and Eczacibasi-Monrol have been working closely for over 6 months to facilitate the technology transfer of radiopharmaceutical manufacturing methods for TLX250-CDx to Eczacibasi-Monrol’s cyclotron production facility in Istanbul. Due to the 3.3 day half-life of ⁸⁹Zr, the excellent product stability of TLX250-CDx coupled with the strong regional logistics through Istanbul, Eczacibasi-Monrol is able to centrally manufacture Telix products for the region, as well as potentially provide production backup for Telix’s EU operations.

Eczacibasi-Monrol General Manager Aydin Küçük stated, "Telix has rapidly emerged as a leading company in the radiopharmaceutical space. We are very pleased to be working with Telix to be able to, in the first instance, include Turkish patients in the international Phase III ZIRCON trial, but to also work closely with Telix to provide market access for their product portfolio in our operating region. We are particularly pleased to be providing regional manufacturing services including back-up for Telix manufacturing operations in Europe, the unique strength of a Turkish company.”

By including Turkish patients in the ZIRCON trial, Telix expects to be able to concurrently file for marketing authorization in Turkey and Europe. The Turkish Ministry of Health is an influential healthcare body in the region and Eczacibasi-Monrol has a successful track record of leveraging domestic product approvals to obtain marketing authorizations in regional countries.

About TLX250

TLX250 (Girentuximab) is being developed by Telix Pharmaceuticals both as a diagnostic PET agent - ⁸⁹Zr-Girentuximab (Phase III) and a therapeutic radiopharmaceutical – ¹⁷⁷Lu-Girentuximab (Phase II). TLX250 is an antibody-based platform that targets carbonic anhydrase IX (CAIX), a cell surface target that is over-expressed in several serious cancers, including renal, lung and esophageal cancer. High CAIX tumour expression is generally correlated with poor prognosis. Telix has prioritized the development of TLX250 for metastatic renal cell carcinoma (RCC), particularly the clear cell variant (ccRCC), which almost ubiquitously over-expresses CAIX.

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or "molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.

About Eczacibasi-Monrol

Eczacibasi-Monrol Nuclear Products Co. is a leading developer, manufacturing and distributor of radiopharmaceutical products in the Balkans, Middle East, North Africa, Central and Eastern Europe. Eczacibasi-Monrol has 9 world-class production facilities, 5 in Turkey and 4 abroad, employing modern and environmentally responsible production technologies. The company also operates cyclotrons in Kuwait, Pakistan and Iraq. Eczacibasi-Monrol is headquartered in Atasehir (a district of Istanbul, Turkey) and services regional nuclear medicine needs through 300 employees and more than 20 distributors, delivering high quality and customer-oriented service to nuclear medicine centers in Turkey and more than 40 countries around the world.

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 "US 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 US Securities Act or an exemption from the registration requirements of the US Securities Act is available. None of the products described in this release have obtained a marketing authorisation in any jurisdiction.