CSD500 Positive Opinion

RNS Number : 0409J

Futura Medical PLC

27 November 2008

 



For immediate release

27 November 2008

Futura Medical plc

('Futura' or 'the Group' or 'the Company')

Positive opinion on CSD500

Futura Medical plc (AIM: FUM), the pharmaceutical group that develops innovative products for consumer healthcare, is pleased to announce that it has received positive regulatory opinion relating to the pharmaceutical aspects of CSD500, the Company's innovative condom to help men maintain a firm erection. The positive opinion marks the pivotal step towards European marketing authorisation for CSD500, which will be sold under the Durex® brand by SSL International plc (SSL).

The Competent Authority's opinion forms a key part of the process to permit the award of a CE Mark, the regulatory approval mechanism for this class of medical device in Europe.  The award of the CE Mark will allow CSD500 to be marketed throughout all EU member states.

CSD500 will be manufactured, marketed and distributed by SSL under the Durex® brand. 

To protect the unique intellectual property of CSD500, patents have been granted, or are proceeding to grant, in 32 consumer markets, including the key commercial territories in Europe and the US, and are pending in a further 4 territories.

James Barder, Futura's Chief Executive, said: 'This positive regulatory opinion for CSD500 marks a pivotal step for Futura and we can now look forward to the award of the CE Mark and the product's commercial launch as a Durex® branded condom. This positive opinion highlights the quality of Futura's technology and project management, and gives us confidence in our regulatory approach to our portfolio of products.'

Leigh Taylor, Head of Innovation at SSL, said: 'CSD500 is a highly innovative solution that will improve the sexual well-being of millions of people. We look forward to seeing this product in the Durex® condom range.'

For any further information please contact:

Futura Medical plc
James Barder, Chief Executive	Tel: [phone]
mail to: [e-mail]	www.futuramedical.co.uk
Canaccord Adams
Ryan Gaffney / Adria Da Breo Richards	Tel: [phone]
For media enquiries please contact:
Buchanan Communications
Mark Court / Rebecca Skye Dietrich / Stasa Filiplic	Tel: [phone]

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

 

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