28 November 2005
Submission of CSD500 device dossier for EU marketing authorisation
Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device group that develops innovative products for the sexual healthcare market, announces submission of the regulatory dossier for the condom safety device CSD500. This dossier has been submitted to the relevant Notified Body/Competent Authority for seeking market authorisation in the European Union.
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 to maintain a fuller and firmer erection during sexual intercourse, thereby helping to reduce the risk of condom slippage.
Durex® 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 were in Europe where the initial marketing authorisations will be sought for CSD500. Although the precise terms of the deal are confidential, Futura will receive royalty based payments from sales of the CSD500 condom.
James Barder, Chief Executive of Futura, said: “We are delighted to reach this major milestone for the first of our three leading products which will reinforce our position as an innovative sexual health company . The dossier submission demonstrates Futura’s ability to work closely with our commercial partners to overcome technical challenges and to drive investor value. Consumers’ sexual health is a key issue for medical authorities with the increase in Sexually Transmitted Infections such as chlamydia. In this context, combined with the evolving market for sexual health products and working with Durex® as the leading global condom brand, we believe CSD500 will generate significant demand.“
Chris Bunniss, SSL’s group marketing and innovations director, said: “Durex® is no longer a brand associated purely with safer sex, but better sex too. We are constantly looking at the development of innovative products in the area of sexual enhancement. We believe CSD500 could become an exciting addition and leading product within the Durex® range that will help to improve the sex lives of our customers.”