CSD500, our Condom Safety Device is a condom developed for use by healthy men. The product incorporates an erectogenic compound to help men maintain a firmer erection during intercourse whilst wearing a condom. The gel is to be licensed under the trademarked brand name of Zanifil®.
By applying the CSD500 condom, a pharmacological dose contained within the teat of the condom will be delivered to the penis. This has been clinically proven to increase local blood flow within the penis which in turn leads to increased firmness, increased penile size and longer duration of an erection.
Discussions with EU regulatory authorities have confirmed that the product will be classified within the EU as a Class III medical device with an ancillary medicinal substance. This classification will allow the product to be sold throughout Europe in the same way as conventional condoms.
Futura has signed a global distribution agreement with the world's largest branded condom manufacturer and distributor, SSL International plc ("SSL" - makers of the Durex® condom range) for the lifetime of the patents.
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. The quality of the study results has reinforced our confidence that CSD500 has significant commercial potential. A good safety and tolerability profile was reported for CSD500.
In November 2008, CSD500 received a positive regulatory opinion relating to the pharmaceutical aspects of the dossier. The positive opinion marks a pivotal step towards European marketing authorisation for CSD500, which will be sold under the Durex® brand by 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.
Once CSD500 is launched, Futura will receive royalty payments from SSL based on product sales.
To protect the unique intellectual property of CSD500, patents have been granted, or are proceeding to grant, in 34 consumer markets, including the key commercial territories in Europe and the US, and are pending in a further two territories.
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