Futura's condom product is aimed at improving the sex lives of healthy men and women. In 2006, the global condom market was worth US$3.3 billion. Our distribution partner SSL International plc, the makers of Durex® are the global leader with a 35% market share of the branded condom market (SSL International plc, Annual Report and Accounts 2009).
CSD500, the Condom Safety Device, will be a condom to be used by healthy men to help maintain a firmer erection during intercourse whilst wearing a condom.
In a double blind clinical study comparing CSD500 against a standard condom co-sponsored by Futura, of those who expressed a preference, a significant proportion of both men and women reported improvements in the firmness of the man's erection during intercourse when using CSD500, compared against a standard condom. A result that was highly statistically significant. Furthermore, of those who expressed a preference, a significant proportion of both men and women also felt that CSD500 increased the penis size and a significant proportion of women reported a longer lasting sexual experience with CSD500.
In the UK, a government report from the Health Protection Agency has shown that in the last 10 years new cases of syphilis have increased by 1130%, HIV by over 300%, gonorrhoea by 45% and chlamydia by 166%. The 'safe sex' message is not getting through and this may partly be linked to the fact that some healthy men can experience a loss of sensitivity when using a condom. This in turn can contribute to a partial loss of erection during intercourse and therefore discourage some men from always wearing a condom during intercourse.
Market research conducted by Acupoll on behalf of Futura showed that up to 22% of healthy men can sometimes suffer a partial loss of erection during intercourse whilst wearing a condom. This may in part explain the growing trend of men to be reluctant to practice safe sex. The Directors believe that CSD500, by helping men maintain a firmer erection whilst wearing a condom, may help promote condom usage and compliance.
Market research commissioned by Futura has shown that the product has significant commercial potential:
- 88% of existing condom users would be interested in purchasing CSD500
- 49% of non-condom users would be interested in purchasing CSD500
In November 2008, CSD500 received a positive regulatory opinion relating to the pharmaceutical aspects of the dossier. This positive opinion marked a pivotal step towards European marketing authorisation for CSD500, which will be sold under the Durex® brand by SSL International plc ("SSL").
The EU Competent Authority's opinion forms a key part of the process to permit the award of the 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. We expect SSL to submit the remaining regulatory data to the Notified Body to complete the dossier during March 2010 with CE mark approval expected before the end of June 2010. Under the terms of the commercial agreement signed between SSL and Futura, the launch and marketing of CSD500 within the Durex® range is the responsibility of SSL.