Futura Medical Regulatory News (FUM)

16 Nov 2006 07:01

Futura Medical PLC16 November 2006 For immediate release 16 November 2006 Futura Medical plc CSD500 Regulatory Update Futura Medical plc (AIM: FUM), the AIM-listed pharmaceutical group that developsinnovative products for consumer healthcare with expertise in sexual health,announces that, together with distribution partner SSL International plc, it isnow proceeding with a user study. This will support the marketing launch ofCSD500 currently scheduled for the final quarter of 2007. The decision to begin a user study follows meetings with the relevant NotifiedBody & Competent Authority (Regulators) during which the remaining data requiredto achieve EU regulatory approval for CSD500 was agreed in principle. This datawill be submitted as soon as practicable and is expected to resolve alloutstanding questions from the Regulators and to lead to EU marketing approval. CSD500 will be marketed as a Durex(R) branded condom containing an activecompound which will enhance the barrier function of the condom. The activecompound will help healthy men maintain a firm erection during sexualintercourse when using a condom. Durex(R) has an approximately 30% share of the global market for branded condomswith sales of £156 million in the financial year ended March 2006. Sixty-sixpercent (66%) of SSL branded condom sales in that financial year were in Europewhere the first marketing authorisations are sought. Futura will receive amilestone payment once marketing authorisation is granted within the EU androyalty based payments from sales of the CSD500 condom. James Barder, Chief Executive of Futura, said: "We now have clear guidance onthe remaining data required to achieve marketing authorisation. Both companiesare fully committed to achieving a successful market launch of CSD500 next year." For further information:Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 685 670mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk Media enquiries:Buchanan CommunicationsMark Court / Rebecca Skye Dietrich Tel: +44 (0) 020 7466 5000 Notes Futura Medical plc Futura Medical is a pharmaceutical group that develops innovative products for the consumer healthcaremarket with a strong expertise in sexual health. The Company is developing a portfolio of products andits strategy is to license their manufacture and distribution to major pharmaceutical and healthcaregroups. Futura's primary focus is on over-the-counter products with particular appeal to men and womenwho are reluctant to discuss potentially embarrassing sexual matters with their doctors. Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London StockExchange. www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock Exchange