Island Pharmaceuticals (ASX:ILA) executed an agreement with PI Health Sciences for a good manufacturing practices (GMP) campaign to produce its Galidesivir drug candidate to support pivotal studies, according to a Thursday Australian bourse filing.
The agreement also includes analytical method validation, reference standard preparation, and stability studies. The campaign is designed to validate and scale production to a level appropriate for late-stage development. Manufacturing activities have begun.
The manufacturing will support its planned Marburg virus disease development program under the US Food and Drug Administration's (FDA) Animal Rule pathway.