- Race Oncology (RAC) partners with Ardena to bolster the manufacturing capabilities of its flagship intravenous (IV) formulation of bisantrene, RC220
- The collaboration serves as a primary source for EU-compliant supplies of RC220 in European clinical studies and serves as a backup for US and Australian programs
- The agreement will last five years but can be extended for successive one-year periods unless terminated earlier
- RAC has put forth an initial budget of $1.5 million towards this collaboration, and Ardena will deliver the first EU and international-compliant GMP supplies of RC220 by the end of 2023
- RAC shares closed 2.98 per cent lower, trading at $1.47 at market close
Race Oncology (RAC) has signed an agreement with leading global contract development and manufacturing organisation (CDMO) Ardena.
The partnership aims to bolster Race Oncology’s manufacturing capabilities, with a specific focus on its flagship intravenous (IV) formulation of bisantrene, RC220.
This strategic move signifies the company’s commitment to advancing its drug development pipeline.
Ardena, a fully integrated CDMO renowned for its expertise, will provide additional Good Manufacturing Practice (GMP) capabilities to Race.
This collaboration will serve as a primary source for EU-compliant supplies of RC220 in European clinical studies, while also serving as a backup source for US and Australian clinical programs.
“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,” RAC CEO and Managing Director Damian Clarke-Bruce said.
Race Oncology has allocated an initial development budget of US$1 million (A$1.5 million) towards this collaboration, and Ardena is expected to deliver the first EU and international-compliant GMP supplies of RC220 by the end of 2023.
The required technology transfer to initiate the program will take place in the coming months.
RAC shares closed 2.98 per cent lower, trading at $1.47 at market close.