Clinical-stage biopharmaceutical company Telix Pharmaceuticals Limited (ASX: TLX) has completed a strategic manufacturing agreement with Global Medical Solutions Ltd (GMS) to manufacture and supply finished unit doses of Telix’s Molecularly Targeted Radiation (MTR) products for certain clinical development programmes.
Global Medical Solutions Ltd is a global manufacturer and distributor of diagnostic and therapeutic radiopharmaceuticals.
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.
Telix CEO, Dr Christian Behrenbruch, said 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.
GMS is a dynamic nuclear medicine company with a well-deserved reputation for manufacturing diagnostic and therapeutic radiopharmaceutical agents to rigorous quality standards,” Dr Behrenbruch said.
“We are pleased to have entered this manufacturing partnership with GMS, which supports both 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.”