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 full erection during intercourse when 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 will result in increased local blood flow which in turn will lead to improved rigidity, tumescence and 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 2007, Futura announced positive results from a user study of CSD500. The study, equally funded by Futura and its marketing and distribution partner SSL, successfully met its primary endpoint. 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 to using a normal 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.
The study included 108 healthy couples, the male of which had at some time experienced a loss or partial loss of erection whilst using standard condoms. A good safety and tolerability profile was reported for CSD500.
In November 2008, CSD500 received 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 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.
It is expected that CE marketing authorisation will be received around the end of 2009 with the launch of CSD500 as soon as possible thereafter.
CSD500 will be manufactured, marketed and distributed by SSL under the Durex® brand. SSL is currently carrying out the detailed preparatory work for CSD500's EU marketing launch, including the selection of the product's brand name within the Durex® portfolio and the product's logo and packaging. Once launched, Futura will receive royalty payments from SSL based on product sales.
Leigh Taylor, Head of Innovation at SSL, made the following statement in April 2009:
“CSD500 is a highly innovative solution that will improve the sexual well-being of millions of people. We are committed to launching CSD500 as soon as possible and believe it will become a leading product in the Durex® portfolio. ”
To protect the unique intellectual property of CSD500, patents have been granted, or are proceeding to grant, in 33 consumer markets, including the key commercial territories in Europe and the US, and are pending in a further 3 territories.
FLD500, a condom-based product designed to improve natural female lubrication during sexual intercourse, uses the same active compound as CSD500 but in FLD500 the active compound is on the outside of the condom so that it is rapidly absorbed through the vaginal mucosa during sexual intercourse. To a large extent, the positioning of FLD500 in the market place, and the final details of the regulatory strategy, will depend upon SSL’s and our experience following the launch of CSD500. It has therefore been agreed between us to prioritise resources towards launching CSD500 as soon as possible.
With 40% of condoms being purchased by women we firmly believe that a female version of CSD500 would have considerable consumer appeal. The precise strategy will be determined with our commercial partner, SSL, in due course.
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