Capsugel reported an agreement with Chiasma, in which Capsugel’s Dosage Form Solutions (DFS) business unit will increase manufacturing operations for the only investigational oral form of octreotide in clinical development. The drug candidate is in Phase 3 clinical trials for the treatment of acromegaly, a disorder that develops when a person's pituitary gland produces too much growth hormone. This agreement extends the companies’ existing product-development relationship.
Scale-up activities for the drug are underway at Capsugel’s site in Livingston, Scotland. Capsugel DFS has already manufactured several clinical batches of the compound, including those needed for the new drug application (NDA) registration. Commercial scale batches are expected to be validated during Q4 2014/Q1 2015.
Octreotide acetate is the lead candidate for Chiasma, a privately owned biopharmaceutical company that develops oral drugs previously only available by injection using its proprietary Transient Permeability Enhancer (TPE) System. Chiasma and Roche will develop and commercialize theproduct. If approved, oral octreotide acetate will offer the first oral alternative for the treatment of acromegaly.