Looking for an edge in both proprietary and off-patent products, Plethora Solutions has licensed two drug delivery platforms from Maelor Pharmaceuticals and Metris Therapeutics in the UK.
In the first agreement, London-based Plethora will obtain a global exclusive licence to Maelor's micelle nanotechnology, for application in Plethora's PSD597 programme for the treatment of interstitial cystitis and painful bladder syndrome (IC/PBS).
IC/PBS is a condition characterised by chronic pelvic pain and afflicts up to two million women in the United States and Europe, yet its causes are unknown and the few available approved treatments fail to bring about immediate and long-lasting symptomatic relief.
But Plethora says it has already completed clinical pilot studies which indicated that its proprietary treatment, PSD597, can result in effective symptomatic relief from IC/PBS.
Because Maelor's technology allows insoluble active pharmaceuticals to be solubilised into an aqueous formulation, Plethora found it to be a good choice for its hydrophobic drug.
Maelor's micelle nanotechnology entraps drug compounds inside minute particles built up from polymers, delivering effective concentrations of drugs which would otherwise be insoluble.
The micelles may also protect the entrapped drug from hydrolysis by enzymes or protect the drug from extreme pH environments, as is the case with lidocaine in urine, thus enabling more drug to be delivered to its site of action.
Nevertheless, Plethora has already completed a phase II study showing it has a method to deliver PSD597 locally into the bladder using a dual compartment syringe.
"Maelor's technology only requires one syringe and one catheter but would cost us more because of the royalties we would have to pay and the cost of production, which would be 70 to 120 per cent more than our method," Mike Wyllie, Plethora's chief scientific officer, told In-PharmaTechnologist.com.
"Our drug delivery platform achieves immediate release whereas micelle nanotechnology offers sustained release, so we may end up using both, it all depends on commercial viability."
Plethora will be responsible for product development and the licence agreement is based upon an upfront payment, development and sales milestones and royalties to Maelor.
In addition, Plethora has in-licensed two clinical stage compounds together with access to a proprietary drug delivery technology from Metris.
The two compounds are M5003 for treatment of dysmenorrhea and M5004 for treatment of endometriosis, targeting conditions which have limited treatment options
Both M5003 and M5004 are new formulations of off-patent pharmaceuticals with large, established long-term safety profiles and well understood mechanisms of action.
They have been reformulated to be administered intra-vaginally utilising Metris's technology which uses a vacular portal system, a sort of "medicated tampons."
This local drug delivery enhances safety by minimising systemic exposure and potentially boosts efficacy by delivering higher doses of the drug to the desired site than would otherwise be possible via oral delivery.
The cost of clinical trials for M5003 and M5004 will be met in part by the placing of 374,995 new Plethora shares with a number of Metris shareholders raising £750,000 (€1.1m). The remaining development costs will be met by Plethora from existing cash resources.
Upon completion of the prescribed Phase II programme for each compound, Plethora intends to license the projects to pharmaceutical marketing partners with participating Metris shareholders sharing in any future license income
While Plethora has considerable experience in clinical trials, it is not a drug manufacturer, so there will be plenty of outsourcing opportunities until its developed products reach the market.