Race executes agreement with Ardena for GMP manufacturing of RC220
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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.
View original content:https://www.prnewswire.co.uk/news-releases/race-executes-agreement-with-ardena-for-gmp-manufacturing-of-rc220-301875089.html
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