Manufacturing will take place at Capsugel facility in Livingston, Scotland
Capsugel's Dosage Form Solutions (DFS) business unit has won a contract with Chiasma of New York and Israel to scale up manufacturing of the oral form of the peptide octreotide for the treatment of acromegaly, which is currently in Phase III trials.
Octreotide, a growth hormone inhibitor developed jointly by Chiasma and Roche, is currently only available in an injectable formulation.
The oral form of the drug will be manufactured at Capsugel’s FDA- and MHRA-accredited site in Livingston, Scotland, which became part of Capsugel’s DFS network when it acquired Encap Drug Delivery in March 2013.
This agreement extends an existing product-development relationship between the two companies, which dates back four years, and sets the stage for them to continue to collaborate on commercial manufacturing preparation.
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 the fourth quarter 2014 or first quarter 2015.
This agreement extends an existing product-development relationship between the two companies
'Capsugel was the best choice of partner because of its combined capabilities in liquid-fill and capsule coating, as well as their track record in scale-up and commercialisation of pharmaceutical liquid-filled products,' said Roni Mamluk, Chief Executive at Chiasma. 'We have been impressed by Capsugel’s ability to quickly transfer the technology and scale up for Phase III manufacturing.'
Capsugel has invested heavily in its capability to optimise and accelerate formulation scale up 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 160L capacity). The facility modifications and equipment installations were successfully completed at the end of the first quarter 2014, with initial commercial scale manufacturing now in progress.
'We are pleased to partner with Chiasma to manufacture this oral drug to help those living with acromegaly,' said Stephen Brown, Managing Director of Capsugel DFS’ Encap Drug Delivery. 'Our expertise in liquid-filled hard capsule development, advanced enteric drug delivery technologies, and handling of hormonal products offers our clients solutions to help bring new medicines to market quickly.'
The Livingston site currently has five development client projects in late Phase III or submission phases that are scheduled to become commercial products in the near term.