Futura Medical Regulatory News (FUM)

10 Nov 2009 07:00



Futura Medical plc

("Futura" or "the Group" or "the Company")

Update on CSD500

Futura Medical plc (AIM: FUM), the pharmaceutical group that develops innovative products for consumer healthcare, announces an update on progress towards the marketing authorisation of its lead product, CSD500, which is scheduled to be launched as a Durex®-branded condom by SSL International plc (SSL).

The generation of additional manufacturing validation data required to complete the CE Mark approval process continues as planned. During this validation work, a number of potential improvements to the manufacturing process have been identified and are currently under evaluation at SSL's condom manufacturing plant in India, where CSD500 will be produced. As well as simplifying the manufacturing process, the proposed changes have the potential to improve product yields and commercial attractiveness. Data is still being collected by a joint development team from SSL and Futura to assess the benefits of the proposed changes.

Given this new information Futura expects SSL to file the additional data for CE Mark approval early in the first quarter of 2010. The regulatory timetable for CE Mark approval is expected to take between 45 and 90 days from submission. Subject to timely CE Mark approval, CSD500 remains on course to be launched later in 2010.

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Notes to Editors

Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.

www.futuramedical.co.uk