Futura Medical Regulatory News (FUM)

12 Aug 2005 07:00

Futura Medical PLC12 August 2005 Press release 12 August 2005 Futura Medical Plc Female Lubrication Device - Product development update Futura Medical plc ("Futura" or "the Company"), the AIM-listed pharmaceuticaland medical device group that develops innovative products for the sexualhealthcare market, today announced it has completed its clinical assessmentprogramme for the Female Lubrication Device ("FLD500"). Following a review of all the clinical data by Futura's panel of consultants andsupported by preliminary feedback from an EU competent authority no furtherclinical work is planned prior to the submission of the dossier for FLD500 forregulatory approval in the European Union. Work is continuing to finalise theproduct, develop the manufacturing process and complete remaining supportivedata including stability in order to submit the dossier. James Barder, Chief Executive of Futura Medical, said: "This is further goodnews for FLD500 and its progress to market, following SSL's exercise of itsoption for global distribution rights for the product. The present clinicalassessment of FLD500 is considered sufficient for regulatory requirements and weavoid the expense and time associated with conducting a further clinical study." In early July Futura announced that SSL International plc ("SSL"), the consumerhealthcare brands company and manufacturer and distributor of DurexTM, theworld's biggest-selling branded condom, had exercised its option for the globalmarketing and distribution rights for FLD500. For further information: Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 845 670mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries:AbchurchSamantha Robbins Tel: +44 (0) 20 7398 7700mailto: samantha.robbins@abchurch-group.com www.abchurch-group.com Notes to Editors: Futura Medical 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 an erectogenic compound within its teat agel to help healthy men maintain an erection throughout intercourse, therebyreducing the likelihood of condom slippage. An exclusive agreement forworldwide distribution has been signed with SSL International plc, the maker ofDurexTM. 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 has exclusive worldwide distribution rights. 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. Futurahas entered into exclusive discussions with a major global pharmaceutical groupfor 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 ViagraTM, CialisTM and LevitraTM. www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange