The agreement confirms OctoPlus' transformation from a formulation services company to one firmly planted in drug development and verifies its commitment to manufacture and market its drug delivery platforms PolyActive and OctoDEX.
The new platform is based on SynBiosys, a biodegradable polymeric system enabling development of controlled release formulations of peptides and small molecules. Its biodegradability, biocompatibility and easily programmable release characteristics make it an ideal platform for the controlled release of peptides and small molecules.
With these three platforms, OctoPlus will be able to develop tailor-made controlled release formulations for all classes of injectable drug compounds.
Dr Theo Flipsen, CEO of InnoCore Technologies said: "It will definitely give a boost to the further development of SynBiosys injectable drug delivery systems and maximize its market potential within the pharmaceutical field."
In initial studies, it was shown to be feasible to develop a six-month release formulation of a peptide based on the SynBiosys polymer that shows true zero-order kinetics without initial burst release. It has further been demonstrated that the polymers can be made into various product configurations, such as coatings, membranes, microspheres and gels. SynBiosys is currently under pre-clinical evaluation by InnoCore Technologies for use as a biodegradable drug eluting coronary stent coating and drug-eluting implant.
Dr Joost Holthuis, president and CEO of OctoPlus said: "What makes us unique with this agreement is that we can offer controlled release platforms for almost any injectable drug compound."
Controlled release formulations reduce injection frequency and increase patient comfort and compliance. They can also improve safety and efficacy of a drug by avoiding peak concentrations and achieving prolonged high concentrations in target organs and tissues.
The new platform will be designed to complement OctoPlus' existing drug delivery platforms PolyActive and OctoDEX, which are based on modified dextran chains - already widely used in medicine in plasma extending products - that can be used to physically trap proteins in a matrix. After injection under the skin, the matrix slowly breaks down, and the protein is gradually released.
Luc Sterkman, OctoPlus' director of medical affairs, told In-Pharmatechnologist.com that one of the attractions of this dextran technology is that, unlike PEGylation (the most widely used method of extending the plasma half life of protein drugs), there is no need to chemically modify the protein itself.
PEGylation cannot be used with some proteins, including hGH, because of chemical incompatibilities between the protein and polymer. But while OctoDEX represents an alternative to PEGylation, there could be additional benefits to combining the two technologies, noted Sterkman.
For example, hiking the loading dose and tightening the dextran matrix might improve the duration of release of an OctoDEX-formulated protein to around three weeks. But load a PEGylated protein into the matrix and you could have a system that would deliver the protein over a month or more, further reducing the number of injections needed by patients.