Through a revised licensing agreement with IsoTis of the US, OctoPlus now has full rights to use and manufacture PolyActive in controlled-release pharmaceuticals, medical coatings and orthopaedics, as well as intellectual property rights to the technology in these applications.
IsoTis, which develops and markets bone-graft substitutes for the treatment of musculoskeletal disorders, retains rights to manufacture, market and sell orthopaedic plugs and cement restrictors based on the PolyActive technology, including those related to its marketed product SynPlug.
OctoPlus originally gained access to PolyActive in 2003, when it acquired IsoTis' affiliate Chienna B.V. That agreement included intellectual property rights to the technology for pharmaceuticals and medical device coatings.
Under the revised agreement, the Dutch company will pay an upfront licensing fee of €1.25m to IsoTis, as well as future royalties on sales of pharmaceutical products based on PolyActive.
According to Joost Holthuis, CEO of OctoPlus, the revised contract " strengthens our intellectual property position for PolyActive and shows our strategic commitment to developing this technology to its full potential within our product pipeline ."
PolyActive is a biodegradable polymeric drug delivery system for the controlled release of biopharmaceuticals and small lipophilic molecules.
It comprises a series of polyether ester multiblock copolymers, based on polyethylene glycol (PEG) and polybutylene terephthalate (PBT).
A major advantage of this system, OctoPlus says, is the ability to vary the amount and length of each of the two building blocks, creating a diverse family of customised polymers.
Polymer matrix characteristics such as rate of controlled release, degradation, swelling and strength can be precisely controlled through the right combination of the two copolymer segments - for example, OctoPlus notes, polymers with a higher PEG content show a faster degradation profile.
Using PolyActive allows the development of burst-free drug delivery systems, while the technology's hydrophilic properties preserve the activity and stability of labile compounds such as proteins, the company adds.
Products made with PolyActive can also be processed into various shapes and configurations, opening up a wide range of applications.
The PolyActive polymer is already marketed in a number of medical devices approved by the US Food and Drug Administration, such as the SynPlug cement restrictor for hip implants mentioned above.
As far as pharmaceutical applications go, OctoPlus is conducting Phase IIa clinical trials with Locteron, a controlled-release formulation of interferon-alfa (BLX-883) for the treatment of chronic hepatitis C. The company expects to release interim results from these studies in the middle of this year, said spokesperson Rianne Roukema.
The interferon-alfa is supplied by OctoPlus' US co-development partner Biolex Therapeutics.
Outside that relationship, the Dutch company is exploring the potential to combine PolyActive with a number of other compounds - and looking for partners to take this work forward.
According to Roukema, the technology would be applicable to any other protein that called for multiple injections.