Capsugel, Chiasma Partner for Manufacture of Octreotide
Capsugel reports that its Dosage Form Solutions (DFS) business unit is scaling up manufacturing for an oral form of the peptide octreotide, a somatostatin analog that is being developed by the Jerusalem-based biopharmaceutical company Chiasma, Inc., a developer of oral drugs using its proprietary Transient Permeability Enhancer technology. Octreotide is currently available onlyby injection.
Chiasma is partnered with Roche for octreotide. The companies signed a license agreement in 2013 for the development and commercialization of octreotide to treat acromegaly and neuroendocrine disorders. Under that agreement, Roche is responsible for commercialization and Chiasma for up to and including Phase III development. Octreotide is currently in Phase III development for treating acromegaly, a disorder that develops when a person’s pituitary gland produces too much growth hormone.
The new manufacturing agreement between Capsugel and Chiasma extends the companies' existing product-development relationship, which dates back four years, and sets the stage for them to continue to collaborate on commercial manufacturing preparation. Scale-up activities are underway at Capsugel’s site in Livingston, Scotland, which became part of Capsugel's DFS network when it acquired Encap Drug Delivery in March 2013. Capsugel DFS has already manufactured several clinical batches of the compound, including those needed for the new drug application registration. Commercial-scale batches are expected to be validated during the fourth quarter 2014 or first quarter 2015.
Capsugel has recently invested at the Livingston site. The company recently installed commercial-scale milling equipment (U20 Comil) and associated containment equipment, in-house printing facilities, and large-scale capsule coating equipment (up to 160 L capacity). The facility modifications and equipment installations were successfully completed at the end of the first quarter 2014, with initial commercial-scale manufactures now in progress.