CSD500 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.
In a double blind clinical study comparing CSD500 against a standard condom, 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 August 2011 Futura's commercial partner was awarded a CE mark for CSD500 enabling CSD500 to be marketed and sold within the EU as a Class III medical device with an ancillary medicinal substance (“CE mark”). In addition to 29 European territories a number of other non-European territories also recognise the CE mark process thereby facilitating registration.
In August 2012, Futura regained the global rights to CSD500 from Reckitt Benckiser (RB) as both parties had been unable to reach acceptable common ground for the continued development and launch of CSD500.
Futura has a clear strategy for commercialising the product. The first steps in this strategy are well advanced with the appointment of contract condom manufacturers and confirmation of the regulatory requirements, which are straightforward, following a meeting with the relevant regulator for the issue of a CE mark. Other than some new manufacturing data on the different condoms used no further data is required. In May 2013, Futura announced that it has submitted the CSD500 regulatory dossier for CE mark approval and is on track to receive regulatory approval in the second half of this year. In May 2013, Futura gained ISO 13485 certification as part of its preparation for becoming the regulatory licence holder of the product.
Under this new commercialisation strategy, Futura will control the manufacture of CSD500 but manufacturing itself will be outsourced to contract condom manufacturers. This approach provides a number of benefits for Futura, including increased control with the ability to license CSD500 to a number of different distributors. Futura's virtual business model remains unchanged, and the Company will therefore not be directly involved in manufacturing, packaging, warehousing or any other discipline associated with integrated businesses.
In April 2013 Futura signed a licensing agreement with Church and Dwight Co Inc for the distribution rights to CSD500 in North America and in a number of key European territories. Church and Dwight's condom brand Trojan® is the number one condom brand in North America and the world's second biggest condom brand by product sales. The financial details of the agreement are not being disclosed although Futura will receive an upfront payment and royalties on all product sales along with certain minimum performance guarantees.
In addition, Futura is in discussion with many of the world's major condom distributors and healthcare companies and is confident of relicensing CSD500 in other key territories.
To protect the unique intellectual property of CSD500, patents have been granted in 36 consumer markets, including the key commercial territories in Europe and the US, and are pending in one remaining territory.