Futura Medical Regulatory News (FUM)

6 Jul 2006 07:01

Futura Medical PLC06 July 2006 For immediate release 6 July 2006 Futura Medical plc Update on New Product Development Futura Medical plc (AIM: FUM), the AIM-listed pharmaceutical and medical devicegroup that develops innovative products for the sexual health market, announcesa product development update to introduce three new products: • DCF100 - a topical analgesic formulation of a generic non-steroidal, anti-inflammatory drug (NSAID). • PET500 - an over-the-counter topical treatment for premature ejaculation (PE) using established topical anaesthetics. • FSD500 - an over-the-counter treatment for female sexual dysfunction (FSD) using glyceryl trinitrate (GTN) as used in Futura's MED2002. Futura has developed a highly efficient and proprietary delivery system for theabsorption of active molecules through the skin. This delivery system is used ina gel form for MED2002, the Company's topical treatment for men with erectiledysfunction (ED) currently undergoing late stage clinical trials. The rapid absorption offered by this delivery system means that low doses ofcertain compounds can be targeted, which brings potential benefits such astargeted site of action, rapid speed of onset, potency and reduced side effects. To maximise the value of this asset, Futura has been evaluating its use in arange of compounds and has decided to conduct further trial work and marketresearch on a topical NSAID and products for PE and FSD. DCF 100 NSAIDs are widely used to reduce pain and inflammation in conditions such asarthritis, rheumatism and sports injuries. Available in oral, topical andinjectable form for more than 30 years, many NSAIDs has been shown to be welltolerated although higher dose oral formulations result in significant adversegastrointestinal events in some users. The NSAID market is estimated to have achieved sales of $17.5 billion in 2005.Topical sales in the UK alone exceeded £52 million in 2004. The world leader inthe topical NSAID market is EmulgelTM, distributed by Novartis. During the Company's evaluation, a specific generic NSAID was identified ashaving the correct characteristics to benefit from Futura's gel deliverytechnology. The topical application of NSAIDs to the skin for targeted-regionaldelivery to underlying tissue is an important therapeutic idea but one which hasyet to be fully realised. By definition, selectivity of action is required anddrug levels at the tissue target below the application site should besignificantly above those required for therapeutic activity whereas those in thesystemic circulation should be 1/50 or less than these. In this way, robustlocal efficacy may be obtained but without the potential for systemic adverseevents sometimes seen with NSAID usage. Futura's initial NSAID gel, known as DCF100, has shown an encouraging absorptionprofile in recent in vitro results (using a synthetic skin membrane model).This in vitro work is now being repeated against the two current topical marketleaders, EmulgelTM and DolautTM but in human skin studies. In vitro human skinstudies are recognised as the gold standard for evaluating topical absorptioncharacteristics. The results of these comparison studies using Futura'sproprietary DCF100 when compared against EmulgelTM and DolautTM are expected inAugust. PET500 Premature ejaculation (PE) is the most common form of male sexual dysfunction.The Global Study of Sexual Attitudes and Behaviour, published in 2003, reportedan overall global prevalence rate in men of 21.4%. PET500 will target men whosuffer situational or occasional PE. Futura's team believe that men whoexperience this mild to moderate form of PE will respond well to a rapid actingcompound which allows the user greater control over his sexual performancewithout a loss of sexual satisfaction either to himself or his sexual partner.PE is a complex condition with many psychological factors. It is thereforeessential that as a non prescription product it is developed in response to meetboth the expectations of the PE sufferer as well as those of his sexual partner. PET500 will utilise Futura's delivery system and a mild topical anesthetic. Futura is currently undertaking multi-country qualitative and quantitativeresearch in order to help design a product to meet this unmet clinical needwhilst clinical formulation work continues in parallel. Assuming satisfactoryqualitative and quantitative market research PET500 is expected to enterclinical trials in the first half of 2007. FSD500 Futura conducted in 2004 a placebo-controlled study on healthy female subjectsat the internationally renowned Porterbrook Clinic in Sheffield, UK. This studydemonstrated that low doses of glyceryl trinitrate (the active compound used inMED2002) improved vaginal microcirculation using photoplethysmography. Thepattern of changes observed in responders mimicked the blood flow changes seenin women during clitoral stimulation and sexual arousal. This may potentiallyimprove natural lubrication although this was not measured in this study. FSD is a complex condition and the role of pharmaceutical treatments comparedwith sexual therapy remains unproven. Nevertheless Futura considers there maybe further opportunities for the compound in the treatment of certain aspects ofFSD and intends to conduct further evaluation during the remainder of 2006 toestablish whether a potential opportunity exists that complies with Futura'sstrategic aims. For further information:Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 6845 670mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries:Buchanan CommunicationsMark Court Tel: +44 (0) 020 7466 5000 For further details please visit www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange