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 has been licensed under the trademarked brand name of Zanifil® which will be displayed on all packaging containing CSD500 condoms throughout the world.
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 on track to deliver this strategy. We have made major progress with our manufacturing strategy by gaining the necessary ISO 13485 certification and are 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 28 European territories, a number of other non-European territories also recognise the CE mark process thereby facilitating registration. Our distributor has recently received regulatory approval in Saudi Arabia – the first approval for a major market outside the EU. Regulatory filings have also been made in further countries in the Middle East, Asia and South America.
The CE mark certificate currently covers one of these supply chains with the second supply chain expected to come on stream by the end of 2015 following regulatory clearance. 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 along with the supply chain for CSD500. We are currently working with our manufacturers to replicate these changes to enable us to extend the shelf life of the product and reduce the cost of goods, for the shared benefit of Futura and our commercial partners. We have also 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.
Futura has signed six licensing and distribution agreements for CSD500 covering many key territories. This out-licensing work continues in order to give CSD500 the strongest possible global distribution platform.
In addition to out-licensing CSD500 to companies that will launch the product under their own brand names we have also created our own condom brand, Blue Diamond®, which is being used by some of our licensing partners. Blue Diamond® is now available online and in store in the Netherlands and Belgium. We are pleased that the in-market experience of the product to date is consistent with the product's performance in clinical studies. Further information is available at www.bluediamondcondom.com.
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 33 countries.
To protect the unique intellectual property of CSD500, patents have been granted in 37 consumer markets, including the key commercial territories in Europe and the US.