Futura Medical PLC
06 July 2006
For immediate release 6 July 2006
Futura Medical plc
Update on New Product Development
Futura Medical plc (AIM: FUM), the AIM-listed pharmaceutical and medical device
group that develops innovative products for the sexual health market, announces
a product development update to introduce three new products:
• DCF100 - a topical analgesic formulation of a generic non-steroidal,
anti-inflammatory drug (NSAID).
• PET500 - an over-the-counter topical treatment for premature
ejaculation (PE) using established topical anaesthetics.
• FSD500 - an over-the-counter treatment for female sexual dysfunction
(FSD) using glyceryl trinitrate (GTN) as used in Futura's MED2002.
Futura has developed a highly efficient and proprietary delivery system for the
absorption of active molecules through the skin. This delivery system is used in
a gel form for MED2002, the Company's topical treatment for men with erectile
dysfunction (ED) currently undergoing late stage clinical trials.
The rapid absorption offered by this delivery system means that low doses of
certain compounds can be targeted, which brings potential benefits such as
targeted site of action, rapid speed of onset, potency and reduced side effects.
To maximise the value of this asset, Futura has been evaluating its use in a
range of compounds and has decided to conduct further trial work and market
research on a topical NSAID and products for PE and FSD.
DCF 100
NSAIDs are widely used to reduce pain and inflammation in conditions such as
arthritis, rheumatism and sports injuries. Available in oral, topical and
injectable form for more than 30 years, many NSAIDs has been shown to be well
tolerated although higher dose oral formulations result in significant adverse
gastrointestinal events in some users.
The NSAID market is estimated to have achieved sales of $17.5 billion in 2005.
Topical sales in the UK alone exceeded £52 million in 2004. The world leader in
the topical NSAID market is EmulgelTM, distributed by Novartis.
During the Company's evaluation, a specific generic NSAID was identified as
having the correct characteristics to benefit from Futura's gel delivery
technology. The topical application of NSAIDs to the skin for targeted-regional
delivery to underlying tissue is an important therapeutic idea but one which has
yet to be fully realised. By definition, selectivity of action is required and
drug levels at the tissue target below the application site should be
significantly above those required for therapeutic activity whereas those in the
systemic circulation should be 1/50 or less than these. In this way, robust
local efficacy may be obtained but without the potential for systemic adverse
events sometimes seen with NSAID usage.
Futura's initial NSAID gel, known as DCF100, has shown an encouraging absorption
profile in recent in vitro results (using a synthetic skin membrane model).
This in vitro work is now being repeated against the two current topical market
leaders, EmulgelTM and DolautTM but in human skin studies. In vitro human skin
studies are recognised as the gold standard for evaluating topical absorption
characteristics. The results of these comparison studies using Futura's
proprietary DCF100 when compared against EmulgelTM and DolautTM are expected in
August.
PET500
Premature ejaculation (PE) is the most common form of male sexual dysfunction.
The Global Study of Sexual Attitudes and Behaviour, published in 2003, reported
an overall global prevalence rate in men of 21.4%. PET500 will target men who
suffer situational or occasional PE. Futura's team believe that men who
experience this mild to moderate form of PE will respond well to a rapid acting
compound which allows the user greater control over his sexual performance
without a loss of sexual satisfaction either to himself or his sexual partner.
PE is a complex condition with many psychological factors. It is therefore
essential that as a non prescription product it is developed in response to meet
both the expectations of the PE sufferer as well as those of his sexual partner.
PET500 will utilise Futura's delivery system and a mild topical anesthetic.
Futura is currently undertaking multi-country qualitative and quantitative
research in order to help design a product to meet this unmet clinical need
whilst clinical formulation work continues in parallel. Assuming satisfactory
qualitative and quantitative market research PET500 is expected to enter
clinical trials in the first half of 2007.
FSD500
Futura conducted in 2004 a placebo-controlled study on healthy female subjects
at the internationally renowned Porterbrook Clinic in Sheffield, UK. This study
demonstrated that low doses of glyceryl trinitrate (the active compound used in
MED2002) improved vaginal microcirculation using photoplethysmography. The
pattern of changes observed in responders mimicked the blood flow changes seen
in women during clitoral stimulation and sexual arousal. This may potentially
improve natural lubrication although this was not measured in this study.
FSD is a complex condition and the role of pharmaceutical treatments compared
with sexual therapy remains unproven. Nevertheless Futura considers there may
be further opportunities for the compound in the treatment of certain aspects of
FSD and intends to conduct further evaluation during the remainder of 2006 to
establish whether a potential opportunity exists that complies with Futura's
strategic aims.
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 6845 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Buchanan Communications
Mark Court Tel: +44 (0) 020 7466 5000
For further details please visit www.futuramedical.co.uk
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The company news service from the London Stock Exchange
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