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Island Pharmaceuticals Executes Agreement for GMP Manufacturing Campaign for Drug Candidate

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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.

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