GlobeNewswire

Telix Pharmaceuticals and Eczacıbaşı-Monrol Sign Manufacturing and Distribution Agreement

Share

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 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.

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 Eczacıbaşı-Monrol

Eczacıbaşı-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. Eczacıbaşı-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. Eczacıbaşı-Monrol is headquartered in Ataşehir (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. 

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Inventiva secures new patent in the US strengthening the protection of its lead product candidate lanifibranor20.8.2019 17:45:00 CESTPress release

Inventiva secures new patent in the US strengthening the protection of its lead product candidate lanifibranor New patent granted in the United States by the USPTO protects the use of lanifibranor for the treatment of fibrotic diseases until June 2035 This patent strengthens the protection of lanifibranor in the United States Daix (France), August 20, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the United States Patent and Trademark Office (USPTO) granted a new patent on August 20, 2019 that protects the use of lanifibranor for the treatment of fibrotic diseases until June 2035. This new patent further strenghens Inventiva’s patent portfolio for lanifibranor, the Company’s lead product candidate, in the United States, which already comprised a New Chemical Entity (NCE) patent and a patent protect

PCI Biotech: Invitation to second quarter and first half 2019 results presentation20.8.2019 15:38:00 CESTPress release

Oslo, Norway, 20 August 2019 - PCI Biotech invites to a presentation of the company's second quarter and first half 2019 results on Wednesday 28 August 2019 at Oslo Cancer Cluster Innovation Park. Time: Wednesday 28 August, 08:30am – 09:30am CEST (local time). Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster Innovation Park, Ullernchausséen 64, Oslo. The presentation will be held in English and if you wish to attend the presentation, please confirm with an e-mail to post@pcibiotech.com. The presentation will also be a live webcast and can be accessed through www.pcibiotech.com. It will be possible to post questions through the webcast console. The interim report and the presentation will be available on www.newsweb.no and on the company's webpage, www.pcibiotech.com from 07:00am (CEST) on 28 August 2019. For further information, please contact: Ronny Skuggedal, CFO Email: rs@pcibiotech.no Mobile: +47 9400 5757 About PCI Biotech PCI Biotech is a biopharmaceutica

Regarding resignation of member of the Supervisory Board20.8.2019 15:30:00 CESTPress release

We hereby inform that, T. Lukoševičius, a member of Supervisory Board of AB Klaipedos nafta (hereinafter – the Company) 20 August 2019 submitted a notice of resignation of members of Supervisory Board of the Company as of 3 September 2019 (this day is the last day of the mandate). It should be noted that, currently the Supervisory Board of the Company consists of 3 members, 2 of them are independent. After the resignation of T. Lukoševičius, the Ministry of Energy of the Republic of Lithuania will conduct the selection of new member of the Supervisory Board. The Supervisory Board is elected by the General Meeting of Shareholders for 4 years. If individual members of the Supervisory Board are elected, they shall be elected only until the end of the term of office of the current Supervisory Board. Jonas Lenkšas, Chief Financial Officer,+370 694 80594

SERSTECH AB: Boardmember Anna Werntoft resigns from the Board of Serstech20.8.2019 13:40:00 CESTPress release

Anna Werntoft will leave the board of directors effective on the 30th of September. The reason for her resignation is that she enters a new operational position with terms that does not allow external assignments. Serstech wishes Anna all the best in her new position and would like to thank her for her contribution while being on the Serstech Board. The Serstech will consist of three Board members until the vacant position is filled. The search for a replacement has started and will be concluded before the next annual general meeting. For further information, please contact: Stefan Sandor, CEO, Serstech AB tel: +46 739 606067 email: ss@serstech.com Thomas Pileby, Chairman of the Board, Serstech AB tel: +46 702 072643 email: tp@serstech.com Company website: www.serstech.com The information was submitted for publication, through the agency of the contact person set out above at 13:40 CET on August 20, 2019. Certified advisor to Serstech is Västra Hamnen Corporate Finance AB, phone: 040-2