Futura Medical Regulatory News (FUM)

25 Apr 2005 07:00

Futura Medical PLC25 April 2005 Press Release 25 April 2005 Futura Medical Plc CSD500 Manufacturing trials Futura Medical plc ("Futura" or "the Company"), the AIM-listed pharmaceuticaland medical device group that develops innovative products for the sexualhealthcare market, today announces completion of initial manufacturing trials ofits Condom Safety Device ("CSD500"). This manufacturing trial follows encouraging stability and compatibility resultson the gel in laboratory studies and will generate essential data to confirm thelaboratory data. This will facilitate the submission of an application to EUregulators for CSD500 marketing authorisation later in the year. CSD500 is a latex condom incorporating within its teat a gel to help healthy menmaintain an erection throughout intercourse, thereby reducing the likelihood ofcondom slippage. James Barder, Chief Executive of Futura, said: "This is an important steptowards the completion of the dossier for CSD500." For further information: Futura Medical plc James Barder, Chief Executive Tel: +44 (0) 1483 845 670 mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries: Abchurch Peter Curtain / Samantha Robbins Tel: +44 (0) 20 7398 7700 mailto: samantha.robbins@abchurch-group.com www.abchurch-group.com Notes to Editors: Futura Medical is an AIM-listed pharmaceutical drug and medical device groupdeveloping innovative products for sexual health. The Company is developing aportfolio of products with the intention of licensing their manufacture anddistribution to major pharmaceutical and healthcare groups. Several agreementshave been signed. Futura's primary focus is on Over the Counter ("OTC") products with particularappeal to men and women who are reluctant to discuss potentially embarrassingsexual matters with their doctors. The Company has three products indevelopment and is in discussions to expand the pipeline. CSD500 is a latex condom incorporating within its teat a gel to help healthy menmaintain an erection throughout intercourse, thereby reducing the likelihood ofcondom slippage. An exclusive agreement for worldwide distribution has beensigned with SSL International plc, the maker of Durex(TM). FLD500, aimed primarily at female partners of male condom users, will help womenmaintain lubrication during intercourse, thereby reducing the risk of condomfailure. SSL International plc holds an option for worldwide distributionrights. In trials, MED2002, a locally applied gel for erectile dysfunction ("ED"), hasshown dramatically improved dermal absorption rates and a dose-ranging study iscurrently being conducted prior to commencement of a Phase III study in late2005. Futura has entered into exclusive discussions with a major globalpharmaceutical group for the worldwide development and marketing of MED2002. A trial to assess the safety of MED2002 in angina patients has already beensuccessfully completed. Subject to regulatory approval the Company intends torecruit men suffering from ED with mild to moderate angina into the Phase IIItrial. Normal medications taken by angina patients prevent the use of availableED treatments such as Viagra(TM), Cialis(TM) and Levitra(TM). www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange