The deal, financial terms of which are not being released, covers a modified version of the bio-adhesive polysaccharide excipient chitosan, developed by Ploughshare as an adjuvant for oral and nasal medications. The compound, which has an improved solubility profile, is designed to increase the immune response to antigen-based vaccines. Archimedes uses chitosan in its ChiSys delivery platform to increase the residency time of certain macromolecular and hydrophilic medications at mucosal surfaces, thereby enhancing their absorption characteristics. The firm hopes that the licensed technology will broaden the range of diseases to which ChiSys can be applied.
An Archimedes spokesman told in-PharmaTechnologist that the intellectual property covered by the deal "has the potential to increase the range of the ChiSys platform, for example by allowing the delivery of certain antigens at physiological pH whilst maintaining their stability and effectiveness." He explained that "certain therapeutically important antigens are unstable at anything other than physiological pH and so couldn't be administered as a spray. This new IP potentially extends the range of antigens that could be delivered intranasally."
The Archimedes spokesman added that the licensed technology "will be incorporated on a case-by-case basis to new programmes and to certain undisclosed existing programmes." He emphasised that the existing platform "can be applied to a broad range of molecules - hydrophilic small molecules, peptides and proteins." One example is Javelin Pharmaceuticals' nasally-delivered morphine drug Rylomine. The product, which was developed using the ChiSys technology, has recently met primary endpoints in a Phase III trial examining it in post-operative pain.
Busy drug development programme Archimedes has a strategic alliance with Montana-based LigoCyte Pharmaceuticals for the use of ChiSys in the development of two vaccines; one against norovirus which has begun Phase I trials, and another against anthrax which is currently in preclinical development.
Under the terms of the agreement, Archimedes will receive a stream of revenues, including R&D payments, milestones and royalties through the development, manufacture and commercialisation of the products. However, the newly-licensed chitosan technology is unlikely to be used in conjunction with Archimedes' existing programmes and will instead be employed in the development of new vaccines.
A recent study by the Freedonia group predicted that the worldwide demand for innovative drug delivery systems will increase by more than 10 per cent a year over the next few years, reaching $132bn (€83.7bn) by 2012. The report predicted a considerable market expansion for drugs delivered nasally, particularly given the recent high-profile failure of new inhaled medications like Pfizer's Exubera and Eli Lilly's AIR.