Melbourne (Australia) and Henderson, NV (U.S.A.) – 27 April 2021. Telix announces it has completed a strategic manufacturing agreement with Global Medical Solutions to manufacture and supply finished unit doses of MTR products for clinical development programs.
Telix is pleased to announce that it has completed a strategic manufacturing agreement with Global Medical Solutions, Ltd. (GMS), a global manufacturer and distributor of diagnostic and therapeutic radiopharmaceuticals, to manufacture and supply finished unit doses of Telix’s Molecularly Targeted Radiation (MTR) products for certain clinical development programs.
Under the terms of the agreement, GMS will initially manufacture and deliver finished unit doses of Telix’s investigational prostate cancer therapy products TLX591 (177Lu-rosopatamab) and TLX592 to sites in Australia for Telix’s planned ProstACT Phase III and CUPID Phase I clinical trials, respectively. The agreement is structured to support Telix’s manufacturing needs for further products and incorporates potential future product distribution requirements in the Asia-Pacific region.
Telix Chief Executive Officer Dr. Christian Behrenbruch stated, “GMS is a dynamic nuclear medicine company with a well-deserved reputation for manufacturing diagnostic and therapeutic radiopharmaceutical agents to rigorous quality standards. We are pleased to have entered this manufacturing partnership with GMS, which supports our immediate clinical development activities in Australia as we commence key clinical trials. Our agreement also paves the way for a longer-term product relationship within the region, particularly in ASEAN countries where GMS is strongly positioned in terms of regulatory expertise and market access.”
GMS Senior Vice President Operations and Business Development Shahe Bagerdjian said, “Telix has quickly grown into a global theranostics leader with an impressive pipeline of investigational products. We look forward to leveraging our strengths in manufacturing and distribution to support Telix’s development of their lead prostate cancer therapy candidates in these important clinical trials in Australia. GMS is committed to expanding access to diagnostic and therapeutic radionuclides in Australia and more broadly in the Asia-Pacific region. We are well placed to support Telix to develop and ultimately deliver these products to patients with prostate cancer in need.”
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About Telix Pharmaceuticals Limited (ASX: TLX)
Telix is a late-stage radiopharmaceutical company developing a broad portfolio of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix’s products address significant unmet medical needs in prostate, kidney, glioblastoma (brain) and hematologic (blood) cancers, as well as a range of immunologic and high value rare diseases.
The Company is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States, and is listed on the Australian Securities Exchange (ASX: TLX).
Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. Food and Drug Administration (FDA) and has been granted Priority Review status by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for Illuccix® in the European Union and Canada. None of Telix’s products have currently received a marketing authorisation in any jurisdiction. For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.