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.
Futura has a clear strategy for commercialising the product and is progressing on track to deliver this strategy. We have made major progress with our manufacturing strategy by gaining the necessary ISO 13485 certification and establishing two outsourced and independent supply chains, one in Europe and one in Asia. In October 2013, Futura was awarded the CE mark certificate for CSD500. The award of the CE mark means that CSD500 can be marketed in all European territories. In addition to these 29 European territories, a number of other non-European territories also recognise the CE mark process thereby facilitating registration.
The recent CE mark certificate currently covers one of these supply chains with the second supply chain expected to come on stream next year as more distribution agreements are agreed. 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.
We have improved the technical and commercial specifications and the supply chain for CSD500 which will extend the shelf life of the product and result in a significant reduction in the cost of goods, for the shared benefit of Futura and our commercial partners. We have filed a new patent in connection with these improvements which, if granted, would extend the commercial value of the product for a further 10 years to 2033.
Since April 2013 Futura has signed a number of licensing agreements for CSD500 in many key territories. This out-licensing work continues in order to give CSD500 the strongest possible global distribution platform. As a further evolution of our strategy we intend to launch CSD500 in at least one European country under a Futura owned brand name, with the distribution outsourced to an established European condom distributor. We continue in discussions in respect of licensing deals in other geographic territories and look forward to making further announcements in due course. In total, the rights to CSD500 have been licensed in 30 countries with initial launches commencing in the second half of 2014.
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.