Race Oncology Ltd. signed an agreement with Ardena Holding NV, global CDMO, to provide additional good manufacturing practice (cGMP)-standard manufacturing capability for Race’s flagship intravenous (IV) formulation of bisantrene, RC220.

Ardena assists biopharma companies with services spanning the drug development life cycle and provides 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 clinical studies. It also provides a backup source for U.S. and Australian clinical programs.

The initial development budget contracted is approximately $1million. Ardena is expected to provide Race’s first EU and international compliant GMP supplies with goal of completion 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 five years and can be automatically extended for successive one-year periods in accordance with the terms of the agreement.

CEO and Managing Director, Damian Clarke-Bruce, said, “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.”