Race Oncology executes agreement with leading global contract development and manufacturing organisation, Ardena as additional partner for GMP manufacturing of flagship RC220 bistanrene formulation Ardena has a long track record of providing sterile injectable products for all stages of clinical development Partnership strengthens the existing manufacturing programs by serving as a primary source for EU compliant supplies required for EU clinical studies, while also providing a backup source for US and Australian clinical programs.
SYDNEY, July 12, 2023 /PRNewswire/ — Race Oncology Limited (“Race”) is pleased to announce that it has signed an agreement with leading global contract development and manufacturing organisation (CDMO), Ardena Holding NV (Ardena) to provide additional Good Manufacturing Practice (cGMP)-standard manufacturing capability for Race’s flagship intravenous (IV) formulation of bisantrene, RC220.
Ardena is a fully integrated CDMO which assists biopharma companies with services spanning the drug development life cycle. The company has a long track record of providing sterile injectable products for all stages of clinical development.
The partnership strengthens Race’s existing manufacturing programs by serving as a primary source for EU compliant supplies of RC220 required for EU clinical studies. It also provides a backup source for US and Australian clinical programs.
CEO and Managing Director, Damian Clarke-Bruce commented: “We are pleased to welcome Ardena as a manufacturing partner, adding to our existing contracted manufacturing capability. Ardena’s position in Europe ensures ease of access to RC220 product for our European clinical trials and adds a second source of FDA-compliant pharmaceutical grade product.”
The initial development budget contracted is approximately USD $1m. Ardena is expected to provide Race’s first EU and international compliant GMP supplies with goal of completion being by the end of 2023. Technology transfer to formally commence the program will occur in the coming months.
The agreement with Ardena is for an initial period of 5 years and shall then be automatically extended for successive one year periods unless terminated earlier in accordance with the terms of the agreement.