• Share price
• Investor PDF
• Interims 2008 PDF

16 November 2006

CSD500 Regulatory Update

Futura Medical plc (AIM: FUM), the AIM-listed pharmaceutical group that develops innovative products for consumer healthcare with expertise in sexual health , announces that, together with distribution partner SSL International plc, it is now proceeding with a user study. This will support the marketing launch of CSD500 currently scheduled for the final quarter of 2007.

The decision to begin a user study follows meetings with the relevant Notified Body & Competent Authority (Regulators) during which the remaining data required to achieve EU regulatory approval for CSD500 was agreed in principle . This data will be submitted as soon as practicable and is expected to resolve all outstanding questions from the Regulators and to lead to EU marketing approval.

CSD500 will be marketed as a Durex® branded condom containing an active compound which will enhance the barrier function of the condom. The active compound will help healthy men maintain a firm erection during sexual intercourse when using a condom.

Durex® has an approximately 30% share of the global market for branded condoms with sales of £156 million in the financial year ended March 2006. Sixty-six percent (66%) of SSL branded condom sales in that financial year were in Europe where the first marketing authorisations are sought. Futura will receive a milestone payment once marketing authorisation is granted within the EU and royalty based payments from sales of the CSD500 condom.

James Barder, Chief Executive of Futura, said : “We now have clear guidance on the remaining data required to achieve marketing authorisation. Both companies are fully committed to achieving a successful market launch of CSD500 next year.”

Site map | Contact us | By using the website, you are deemed to have accepted the terms of the disclaimer.

© and Database Right: Futura Medical Plc 2004 - 2008. All rights reserved.