Futura Medical Regulatory News (FUM)

28 Nov 2005 07:01

Futura Medical PLC28 November 2005 For immediate release 28 November 2005 Futura Medical plc Announces the submission of CSD500 device dossier for EU marketing author isation Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device groupthat develops innovative products for the sexual healthcare market, announcessubmission of the regulatory dossier for the condom safety device CSD500. Thisdossier has been submitted to the relevant Notified Body/Competent Authority forseeking market authorisation in the European Union. CSD500 will be marketed as a Durex(TM) branded condom containing an activecompound which will enhance the barrier function of the condom. The activecompound will help healthy men to maintain a fuller and firmer erection duringsexual intercourse, thereby helping to reduce the risk of condom slippage. Durex(TM) has a 29% share of the global market for branded condoms with sales of£146 million in 2004. Seventy nine percent (79%) of SSL group sales in 2004 werein Europe where the initial marketing authorisations will be sought for CSD500.Although the precise terms of the deal are confidential, Futura will receiveroyalty based payments from sales of the CSD500 condom. James Barder, Chief Executive of Futura, said: "We are delighted to reach thismajor milestone for the first of our three leading products which will reinforceour position as an innovative sexual health company. The dossier submissiondemonstrates Futura's ability to work closely with our commercial partners toovercome technical challenges and to drive investor value. Consumers' sexualhealth is a key issue for medical authorities with the increase in SexuallyTransmitted Infections such as chlamydia. In this context, combined with theevolving market for sexual health products and working with Durex(TM) as theleading global condom brand, we believe CSD500 will generate significant demand." Chris Bunniss, SSL's group marketing and innovations director, said: "Durex(TM) isno longer a brand associated purely with safer sex, but better sex too. We areconstantly looking at the development of innovative products in the area ofsexual enhancement. We believe CSD500 could become an exciting addition andleading product within the Durex(TM) range that will help to improve the sex livesof our customers." 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:Buchanan CommunicationsMark Court / Tim Anderson / Rebecca Dietrich Tel: +44 (0) 020 7466 5000 Notes to Editors: Futura Medical plc 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. Exclusiveworldwide distribution agreements have already been signed in respect ofFutura's two condom safety products, CSD500 and FLD500, with SSL Internationalplc, the makers of Durex(TM) condoms. For further information please visit www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange