Race Oncology Limited (ASX:RAC) has signed an agreement with leading global contract development and manufacturing organisation Ardena Holding NV 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 programmes 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 programmes.
CEO and Managing Director, Damian Clarke-Bruce, said 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 US$1 million. 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 programme will occur in the coming months.
The agreement with Ardena is for an initial period of five years and shall then be automatically extended for successive one year periods unless terminated earlier in accordance with the terms of the agreement.
