TPR100 utilises
our skin delivery technology
TPR100 will provide topical pain relief. The product incorporates a non-steroidal anti-inflammatory drug ("NSAID") and utilises Futura's DermaSys® technology.
Futura has developed a highly efficient and proprietary delivery technology, DermaSys®, for the absorption of active molecules through the skin. The DermaSys® technology was originally developed for use in our topical treatment for erectile dysfunction, MED2002. DermaSys® is a versatile and bespoke technology in that it can be tailored to suit the specific active compound being used and the therapeutic indication. Such targeted delivery offers an optimised profile in terms of dose, onset time and duration of effect as well as an improved safety profile through lower systemic uptake and the reduced risk of side effects.
We have completed a clinical study that showed significant superiority in terms of skin penetration of the NSAID molecule for TPR100 compared with the commercially available, market-leading product. Clinical tests carried out by Futura have shown that TPR100 achieves between 30 to 40 times higher bioavailability than those achieved by the market-leading product with none of the side effects which are seen with oral NSAID products.
We have previously consulted with relevant regulatory authorities and believe the regulatory pathway for TPR100 in a number of key commercial territories is relatively straightforward as the active compound is well-characterised and has already been approved in both oral and topical form for the indication of pain relief.
In June 2010, we signed an agreement with GlaxoSmithKline plc (GSK) for the development of TPR100. Under the terms of the agreement GSK will fully fund and be responsible for all clinical and regulatory development. GSK will also make modest annual payments to Futura whilst development work proceeds. Subject to satisfactory clinical outcomes and regulatory approvals both parties expect to enter into a commercial distribution agreement in due course.