Company Profile
Futura Medical plc (“Futura”) is a pharmaceutical drug and medical device group that develops innovative products for sexual health. Our
products under development are focused on the sexual wellbeing of healthy men and women and the treatment of sexual dysfunction. Our
primary focus is on non-prescription products with particular appeal to men and women who are reluctant to discuss potentially
embarrassing sexual matters with their doctors. A summary of our main products under development is set out below.
CSD500 – Condom Safety Device
CSD500 will be a condom to be used by healthy men. It incorporates an erectogenic compound in the tip of the condom to help maintain
a full erection throughout intercourse in order to reduce condom slippage. The gel is to be licensed under the trademark Zanifil™.
Market research has identified that 22 per cent of healthy men have experienced a partial loss of penile rigidity before or during
intercourse as a result of wearing a condom. This not only discourages the use of condoms but also increases the risk of the condom
slipping completely off the penis during intercourse.
It has been estimated that approximately two percent of condoms slip off during intercourse and that global condom usage in 2004
exceeded 14 billion. This implies that incidences of “slippage” may occur up to 280 million times a year, with the resultant risk of both
unwanted pregnancies and the transference of sexually transmitted infections. The Directors believe that by making condom use more
acceptable CSD500 will considerably extend the market as well as reduce the risk of condom slippage.
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 a global distribution agreement for CSD500 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.
On 28 November 2005, the regulatory dossier for CSD500 was submitted to the relevant Notified Body and Competent Authority seeking
marketing authorisation in the European Union.
FLD500 – Female Lubrication Device
FLD500 is a “sister” product to CSD500. However, the erectogenic compound will be applied to the outside of a condom, thereby coming
into direct contact with the vagina during sexual intercourse.
A survey conducted on behalf of Futura in the UK showed that about 40 per cent of condoms are purchased by women. A further survey
conducted amongst women on behalf of Futura showed there was a high level of appeal for FLD500, which was perceived to be a unique
product providing a competitive advantage for better and safer sex.
FLD500 is aimed at helping healthy women maintain lubrication during intercourse, reducing the risk of condom failure. The product is
intended to be classified within the EU as a Class III medical device with an ancillary medicinal substance.
During sexual penetration a pharmacological dose will be delivered to the clitoral and peri-clitoral regions. This will result in improved local
blood flow which in turn should lead to increased vaginal lubrication. By reducing friction during intercourse, this should reduce the risk of
condom slippage or breakage. As well as improving safety, the Directors believe this may facilitate an enhanced overall sexual experience
for both partners.
Futura also has a global distribution licence for FLD500 with the world’s largest branded condom manufacturer and distributor, SSL for the
lifetime of the patents.
MED2002* – Male Erectile Dysfunction Treatment
MED2002 will be a ‘rub-on’ gel applied directly to the penis for the treatment of male erectile dysfunction. The Directors believe this will
become the first pharmaceutical treatment for erectile dysfunction which will be available without the need of a doctor’s prescription.
It is estimated that 50 per cent of men aged 45 or over have some degree of erectile dysfunction. The British Journal of Urology expects
the number of men with erectile dysfunction to double from its current level of 152 million worldwide to 302 million by 2025.
The Futura product is based on glyceryl trinitrate, a potent vasodilator, which has been used for the treatment of angina and associated
cardio-vascular defects for more than 40 years and has been determined to be a safe and effective drug with a known side-effect profile.
Futura is in the final stage of formal approval with a major global pharmaceutical group for the worldwide development and
commercialisation of MED2002.
Website
More information regarding Futura Medical plc can be found on our website www.futuramedical.co.uk
Notes
*MED2002 describes all Futura’s different gel formulations applied directly to the penis for the treatment of male erectile dysfunction. Futura may code certain
formulations, for identification purposes, by altering the final digit, e.g. MED2001 or MED2004.
