Pharma Focus Asia

Telix Pharmaceuticals and Eczacıbaşı-Monrol Sign Manufacturing and Distribution Agreement

Friday, June 14, 2019

Telix Pharmaceuticals Limited, 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 Eczacıbaşı-Monrol.

Under the terms of the agreement, Telix has appointed Eczacıbaşı-Monrol as a radiopharmaceutical production partner and distributor in Turkey/Middle East/North Africa. Eczacıbaşı-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, “Eczacıbaşı-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 Eczacıbaşı-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 Eczacıbaşı-Monrol’s technical strength within the Turkish production team.”

Telix and Eczacıbaşı-Monrol have been working closely for over 6 months to facilitate the technology transfer of radiopharmaceutical manufacturing methods for TLX250-CDx to Eczacıbaşı-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, Eczacıbaşı-Monrol is able to centrally manufacture Telix products for the region, as well as potentially provide production backup for Telix’s EU operations.

Eczacıbaşı-Monrol General Manager Aydın 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 Eczacıbaşı-Monrol has a successful track record of leveraging domestic product approvals to obtain marketing authorizations in regional countries.

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