Futura Medical plc, the pharmaceutical drug and medical device group, it develops innovative products for sexual health, announced that it has entered into a development agreement with GlaxoSmithKline Consumer Healthcare (GSK-CH) for Futura's topically applied gel (MED2002) for the treatment of erectile dysfunction (ED). GSK-CH is a division of GSK plc, the global pharma and healthcare group.

If successful, MED2002 would be the world's first non-prescription pharmaceutical treatment for men with ED. By being available from pharmacies without the need for a doctor's prescription, MED2002 will be a convenient treatment for men with ED.

While some treatments are taken orally or injected, MED2002 is topically applied and provides a rapid onset of action. This has considerable advantages, in terms of giving a local rather than the systemic effect that is associated with other current ED treatments.

Treatments such as phosphodiesterase inhibitors, sildenafil, tadalafil and vardenafil, have revolutionised the market for ED. This has led to an enormous increase in public awareness of this condition, which affects, to some degree, 50 per cent of men aged 45 or over. It is expected that the number of men with ED will double from its current level of 152 million, worldwide to 322 million by 2025 due to ageing populations. Despite this, it is estimated that only 15 per cent of men with ED will seek prescription treatment.

GSK will provide global regulatory and technical support for MED2002. The programme is expected to comprise up to three studies involving approximately 1,500 men with ED and several additional safety studies, to support the existing studies already completed by Futura. The clinical development programme is already in an advanced stage of planning and is currently expected to complete in time for regulatory submissions in 2008.

The first clinical study that both parties have committed to is expected to commence before the end of 2006. Under the terms of the agreement GSK will pay 65 per cent of the clinical development program costs for MED2002 and Futura will pay 35 per cent. The cost of the entire clinical development program is expected to be about £3.65 million which would result in a contribution from Glaxo Smith Kline of about £2.4 million.

The agreement also includes licence terms, that are not yet legally binding but are intended to be incorporated into a global licence agreement, to be negotiated and executed by both parties for MED2002 following final approval from GSK. Under these terms GSK would have global distribution and marketing rights for MED2002 for the lifetime of the MED2002 patents, currently expected to run until around 2024. Negotiations of the detailed terms and conditions are continuing with the intention of executing the licence agreement as soon as practicable. The clinical development programme will run in parallel.

Under the licence agreement, Futura would also grant GSK first refusal rights, on two other products currently in the early stages of development, a non-prescription treatment for arousal and desire disorders associated with female sexual dysfunction and a non-prescription treatment for premature ejaculation.

James Barder, Chief Executive of Futura, said: "Over the past year we have developed a close working relationship with the team at Glaxo Smith Kline and have been impressed by the dynamism, professionalism and expertise they have brought to the development of MED2002. We look forward to continuing this extensive collaboration and converting the potential of MED2002 into a leading product as the world's first licensed non-prescription treatment for men with erectile dysfunction."

Paul Berman, VP Business Development and Strategic Planning, GSK-CH, Europe, said: "This is a very exciting new business opportunity for GSK Consumer Healthcare, one that meets a significant unmet need in the marketplace, and the prospect to be the first regulatory approved non-prescription erectile dysfunction product is compelling. We have an extensive clinical development program ahead and we look forward to working with Futura Medical to fulfil this opportunity."