Futura Medical Regulatory News (FUM)

6 Sep 2006 07:01

Futura Medical PLC06 September 2006 For immediate release 6 September 2006 Futura Medical Plc New topical analgesics formulation beats leading brands in human skin studies Futura Medical plc (AIM: FUM) the pharmaceutical and medical device group, todayannounces that its new topical non-steroidal anti-inflammatory (NSAID)formulation, known as DCF100, has shown impressive results in recently conductedin vitro human skin permeation studies with permeation rates in excess of eighttimes higher than the world's current market leader. Permeation through human abdominal skin was measured in a validated model for avariety of formulations in studies conducted by Professor Mike Roberts at theUniversity of Queensland in Australia. Professor Roberts is a world-renownedexpert in skin permeability of pharmaceutical compounds. The dramatic improvement in permeation rates observed in DCF100 formulationscompared with two over the counter topical brands, including the world's marketleader, Voltarol(R) Emulgel, is highlighted in a graph viewable at http://www.futuramedical.co.uk/archive/060906_graph.pdf DCF100 also showed astatistically significant improvement in drug delivered through the skin in a 24hour period from a single dose compared with Pennsaid(R), a prescription basedtopical NSAID which up until now has provided the best reported permeation ratesfor topical Diclofenac. Voltarol(R) Emulgel worldwide topical sales are estimated to be US$215 millionout of a current worldwide market for topical NSAIDs in 2005 of US$2.35 billion. No topical NSAID has yet received marketing authorisation within the USA fromthe Food and Drug Administration (FDA). This is due to concerns that NSAIDscannot permeate the skin in sufficient quantity to deliver a therapeutic dose.This may however change with the regulatory dossier on Pennsaid(R) recentlybeing submitted to the FDA to obtain marketing authorisation due to its improvedskin permeation compared with existing topical NSAIDs. We expect the market fortopical NSAIDs to grow significantly once the FDA approves products. Plans are at an advanced stage to conduct human tissue micro-dialysis and plasmalevel studies later this year with Futura's preferred DCF100 formulation. Thesestudies aim to confirm local targeted delivery, thereby demonstrating thepotential for excellent clinical efficacy but without systemic uptake and theassociated side effects often associated with oral NSAIDs. In the meantimediscussions are underway with potential distributors for DCF100, the outcome ofwhich will be announced to shareholders in due course. Professor Mike Roberts said: "Topical formulations have sought to deliver aneffective therapeutic dose of Diclofenac from a safe and user friendly topicallyapplied formulation. Initial in vitro studies suggest Futura's DCF100formulations deliver high effective doses of Diclofenac and are supportive oftheir further clinical development for topical NSAIDs." James Barder, Chief Executive of Futura, said: "These results beat our owninternal expectations and we see a significant opportunity to develop a furthervaluable asset for our shareholders at limited cost and risk. These studiesalso support our belief that our delivery system, initially developed forMED2002, has significant commercial applications beyond MED2002." For further information:Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 685 670email to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries:Buchanan Communications Tel: +44 (0) 20 7466 5000Mark Court Notes Futura Medical plc Futura Medical is a pharmaceutical drug and medical device group largelydeveloping innovative products for the sexual health market. The Company isdeveloping a portfolio of products and its strategy is to license theirmanufacture and distribution to major pharmaceutical and healthcare groups.Futura's primary focus is on over-the-counter products. Futura is based in Guildford, Surrey, and its shares trade on the AIM market ofthe London Stock Exchange. For further details please visit www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange