Race Oncology Limited is pleased to announce that it has signed an agreement with Ardena Holding NV one of the world's leading contract development and manufacturing companies to provide additional good manufacturing practice (cGMP) manufacturing capability for the intravenous (IV) formulation of bisantrene, RC220, Race's lead product.

Ardena is a fully integrated CDMO that supports biopharmaceutical companies by providing services spanning the drug development cycle. The company has a long history of providing sterile injectable products at all stages of clinical development.

This partnership strengthens Race's existing manufacturing programs by serving as the primary source for EU compliant supplies of RC220 required for EU clinical studies. It is also a back-up source for US and Australian clinical programs.

Damian Clarke-Bruce, CEO of Race, commented:  “We are pleased to welcome Ardena as a manufacturing partner, in addition to our existing contract manufacturing capability. Ardena's position in Europe ensures easy access to the RC220 product for our European clinical trials and adds a second source of FDA-compliant pharmaceutical grade product. »

The initial development budget under the contract is approximately $1 million. Ardena is expected to supply Race with the first GMP supplies that comply with European and international standards, with the aim of completing the project by the end of 2023. Technology transfer to officially launch the program will take place in the coming months.

The agreement with Ardena is entered into for an initial period of five years and will then be automatically extended for successive periods of one year, unless terminated earlier in accordance with the terms of the agreement.

 

Source:prnewswire.com

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