4th Jul 2006 14:39
Futura Medical PLC04 July 2006 For immediate release 4 July 2006 Futura Medical plc Announces agreement to develop non-prescription treatment for erectile dysfunction (MED2002) with GlaxoSmithKline plc Futura Medical plc (AIM: FUM), the pharmaceutical drug and medical device groupthat develops innovative products for sexual health, announced today it hasentered into a development agreement with GlaxoSmithKline Consumer Healthcare(GSK CH) for Futura's topically applied gel (MED20021) for the treatment oferectile dysfunction (ED). GSK CH is a division of GlaxoSmithKline plc(GlaxoSmithKline), the global pharmaceutical and healthcare group. If successful, MED2002 would be the world's first non-prescriptionpharmaceutical treatment for men with ED. By being available from pharmacieswithout the need for a doctor's prescription, MED2002 will be a convenienttreatment for men with ED. While some treatments are taken orally or injected, MED2002 is topically appliedand provides a rapid onset of action. This has considerable advantages in termsof giving a local rather than the systemic effect that is associated with othercurrent ED treatments. Treatments such as phosphodiesterase inhibitors, such as sildenafil, tadalafiland vardenafil, have revolutionised the market for ED. This has led to anenormous increase in public awareness of this condition, which affects, to somedegree, 50 per cent of men aged 45 or over. It is expected that the number ofmen with ED will double from its current level of 152 million worldwide to 322million by 2025 due to ageing populations2. Despite this, it is estimated thatonly 15 per cent of men with ED will seek prescription treatment3. This isattributed to the embarrassment associated with the need, on all current EDpharmaceutical treatments, to consult a doctor in order to obtain aprescription. GlaxoSmithKline will provide global regulatory and technical support forMED2002. The program, to be run and managed primarily by GlaxoSmithKline, isexpected to comprise up to three studies involving approximately 1,500 men withED and several additional safety studies to support the existing studies alreadycompleted by Futura. The clinical development program is already in an advancedstage of planning and is currently expected to complete in time for regulatorysubmissions in 2008. The first clinical study that both parties have committed to is expected tocommence before the end of 2006. Under the terms of the agreementGlaxoSmithKline will pay 65% of the clinical development program costs forMED2002 and Futura will pay 35%. The cost of the entire clinical developmentprogram is expected to be about £3.65 million which would result in acontribution from GlaxoSmithKline of about £2.4 million. The Agreement also includes licence terms that are not yet legally binding butare intended to be incorporated into a global licence agreement to be negotiatedand executed by both parties for MED2002 following final approval from GSK.Under these terms GlaxoSmithKline would have global distribution and marketingrights for MED2002 for the lifetime of the MED2002 patents, currently expectedto run until around 2024. Negotiations of the detailed terms and conditions arecontinuing with the intention of executing the licence agreement as soon aspracticable. The clinical development program will run in parallel. Under the licence agreement, Futura would also grant GSK first refusal rights ontwo other products currently in the early stages of development: anon-prescription treatment for arousal and desire disorders associated withfemale sexual dysfunction and a non-prescription treatment for prematureejaculation. James Barder, Chief Executive of Futura, said: "Over the past year we havedeveloped a close working relationship with the team at GlaxoSmithKline and havebeen impressed by the dynamism, professionalism and expertise they have broughtto the development of MED2002. We look forward to continuing this extensivecollaboration and converting the potential of MED2002 into a leading product asthe world's first licensed non-prescription treatment for men with erectiledysfunction." Paul Berman, VP Business Development and Strategic Planning, GlaxoSmithKlineConsumer Healthcare Europe, said: "This is a very exciting new businessopportunity for GSK Consumer Healthcare, one that meets a significant unmet needin the marketplace, and the prospect to be the first regulatory approvednon-prescription erectile dysfunction product is compelling. We have anextensive clinical development program ahead and we look forward to working withFutura Medical to fulfil this opportunity." For further information:Futura Medical plcJames Barder, Chief Executive Tel: +44 (0) 1483 685 670mail to: [email protected] www.futuramedical.co.uk Media enquiries:Buchanan CommunicationsMark Court Tel: +44 (0) 20 7466 5000 GlaxoSmithKline Consumer HealthcareClaire Dixon Tel: +44 (0) 20 8047 4296 / +44 (0) 7717 801 391 1. MED2002 is the term used by Futura to describe all the different gelformulations applied directly to the penis for the treatment of male erectiledysfunction. Futura may code certain formulations, for identification purposes,by altering the final digit. For example MED2001 or MED2004. 2. BJU Int, July 1999, vol. 84 part 1, pages 50-56 3. Prog Urol February 2003, vol 13 part 1, pages 85-91 Notes Futura Medical plc Futura Medical is a pharmaceutical drug and medical device group developinginnovative products for the sexual health market. The Company is developing aportfolio of products and its strategy is to license their manufacture anddistribution to major pharmaceutical and healthcare groups. Futura's primaryfocus is on over-the-counter products with particular appeal to men and womenwho are reluctant to discuss potentially embarrassing sexual matters with theirdoctors. Futura is based in Guildford, Surrey, and its shares trade on the AIM market ofthe London Stock Exchange. For further details please visit www.futuramedical.co.uk This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Futura MedicalGlaxosmithkline