Capsugel today announced an agreement with Chiasma, Inc., wherein Capsugel’s Dosage Form Solutions (DFS) business unit is scaling up manufacturing 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, which dates back four years, and sets the stage for them to continue to collaborate on commercial manufacturing preparation.
Scale-up activities for the drug are underway 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. 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.
“Capsugel was the best choice of partner because of their combined capabilities in liquid-fill and capsule coating, as well as their track record in scale-up and commercialization of pharmaceutical liquid-filled products,” said Roni Mamluk, PhD, Chief Executive Officer at Chiasma. “We have been impressed by Capsugel’s ability to quickly transfer the technology and scale-up for Phase 3 manufacturing.”
Capsugel has invested heavily in its capability to optimize 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 manufactures now in progress.
"We are pleased to partner with Chiasma to manufacture this oral drug to help those living with acromegaly,” said Stephen Brown, PhD, 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."
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 TPE™ System ("Transient Permeability Enhancer"). Chiasma and Roche will develop and commercialize the product. The scale-up agreement with Capsugel marks an important milestone in the product's development. If approved, oral octreotide acetate will offer the first oral alternative for the treatment of acromegaly.
Leveraging development and manufacturing centers in the U.S., Europe and Japan, Capsugel’s DFS business unit is working on a broad array of client projects spanning new chemical entities, specialty products, generics, and consumer and nutrition products. Services include feasibility studies, formulation development and optimization, scale-up and commercial scale manufacture of approved products. The Livingston site currently has five development client projects in late Phase 3 or submission phases that are scheduled to become commercial products in the near term.