The agreement will see the contract development and manufacturing organisation (CDMO) help advance Grünenthal’s abuse-deterrent formulation technology platform, INTAC, for the German pharma firm’s opioid pipeline.
The technology platform itself is based on the Hot Melt Extrusion (HME) process, explained Grünenthal spokesperson Steffen Fritzsche.
“HME is an innovative and viable technique that has been effectively utilised in the pharmaceutical industry,“ he told in-Pharmatechnologist.com. “With that technology we are able to provide tailored formulations for extended release, immediate release and modified drug release additionally providing our established abuse deterrent properties.“
When applied to opioid drugs, the platform can help tackle the growing problem of abuse in the US, something that is falling more and more onto the shoulders of drugmakers, he continued.
“Technologies with proven track record have a clear advantage in this competitive environment. This is favourable for Grünenthal since our company has been a pioneer and is today an acknowledged expert in the field of abuse deterrent formulations.“
Preferred CDMO
Financial terms of the deal were not revealed but Patheon, acting as a strategic partner, says production work will be conducted under its “condo model,” a service for clients which helps to simplify manufacturing by bringing equipment and technologies into the CDMO’s own facilities.
“This agreement is a tangible example of the deeper, collaborative relationships we are pursuing and winning with clients,” said Mike Lehmann, EVP at Patheon.
And therefore, Fritzsche told us: “A full set of equipment required for development and manufacturing activities with Grünenthal’s proprietary technology will be installed at Patheon’s Cincinnati manufacturing site.Contracts are set-up to ensure that IP rights of involved parties are fully considered.“
The decision to select Patheon was driven in part by Grünenthal‘s established development relationship with the CDMO, he added.