Plethora Solutions Holdings Plc Regulatory News (PLE)

22 Jun 2006 07:02

Plethora Solutions Holdings PLC22 June 2006 For Immediate Release 22nd June 2006 PLETHORA SOLUTIONS HOLDINGS PLC Two genito-urinary compounds and delivery technology licensed and funded via novel agreement Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM: PLE), aUK-based specialty pharmaceutical company, is pleased to announce that it hasin-licensed two clinical stage compounds together with access to a proprietarydrug delivery technology from Metris Therapeutics Limited ('Metris'), a privateUK drug development company. The two compounds are M5003 for treatment ofdysmenorrhea (period-pain/menstrual cramps) and M5004 for treatment ofendometriosis (a painful condition of the womb often resulting in infertility).Both of these commonly occurring conditions have limited treatment options.Plethora will undertake a Phase IIb study for M5003 and a pilot clinical studyfor M5004. The cost of these studies will be met in part by the placing of 374,995 newordinary Plethora shares with a number of Metris shareholders raising £750,000.The remaining development costs will be met by Plethora from existing cashresources. Both M5003 and M5004 are new formulations of off-patent pharmaceuticals withlarge, established long-term safety profiles and well understood mechanisms ofaction. These drugs have been reformulated to be administered intra-vaginallyutilising proprietary Metris technology which forms the basis for new patentcoverage. This local drug delivery enhances safety by minimising systemicexposure and potentially enhances efficacy by delivering higher doses of thedrug to the desired site than would otherwise be possible via oral delivery. Endometriosis is a painful, chronic disease that occurs when the tissue whichnormally lines the uterus is disseminated outside of the uterus. This misplacedtissue responds to the menstrual cycle in the same way as normal uterine lining.However, blood and tissue shed from endometrial growths have no way of leavingthe body, causing internal bleeding and inflammation. Endometriosis occurs inaround 20-30% of women with fertility problems. There is currently no cure forendometriosis. Dysmenorrhea is painful, often incapacitating, menstrual cramp which afflictsmore than 50% of women of reproductive age. 'Primary' dysmenorrhea occurs withthe onset of menstruation in healthy females. 'Secondary' dysmenorrhea may beginlater in life and is strongly linked with endometriosis, uterine fibroids andpelvic infection. Pharmaceutical treatment for both conditions is based on non-steroidalanti-inflammatory drugs, painkillers and hormone therapy. While these treatmentscan bring about a degree of symptomatic relief, they all carry some risk of sideeffects. M5003 and M5004 are convenient, "on-demand" treatments which have beendesigned to minimise systemic exposure to anti-inflammatory and analgesic agentswhile giving safe and effective relief from pain. Upon completion of the prescribed Phase II programme for each compound, Plethoraintends to license the projects to pharmaceutical marketing partners withparticipating Metris shareholders sharing in any future license income. Metrisshareholders participating in the placing are SV Life Sciences, SofinnovaCapital, 3i Group plc and Northern Venture Managers. Steven Powell, CEO of Plethora, commented: "This agreement enables us tocontinue to replenish our pipeline with new products and access novel drugdelivery technologies without having a major impact on existing cash resources.We expect our current development pipeline of urology projects, excluding theMetris programme, to have completed their respective Phase II programmes by mid2007. The Metris programme provides a new generation of licensable projects andbroadens our focus into significant, poorly met medical needs in femaleuro-gynaecology. In addition, Metris' drug delivery platform could offer furthertherapeutic development opportunities in other clinical indications. The funding mechanism provides Metris shareholders with access to Plethora'sclinical development expertise to drive two of its programmes forward withouthaving to fund this capability internally. In addition, by part-funding theprogramme through an equity investment, Metris can share in future valuegenerated by the current, broad Plethora pipeline". For further information contact: Plethora Solutions Tel : 0207 269 8630Steven Powell Collins Stewart Tel : 0207 523 8350Tim Mickley Buchanan Communications Tel : 0207 466 5000Isobel Podda About Plethora: Plethora is focused on the development of products for the treatment ofurological disease. The Company has products in clinical development for thetreatment of overactive bladder, benign prostatic hyperplasia, stress urinaryincontinence, interstitial cystitis and premature ejaculation. In January 2006,Plethora acquired Minneapolis (Mn) based Timm Medical Technologies Inc whichmarkets products for the treatment of erectile dysfunction (ED) to urologyclinics through a US-based speciality sales team. The Company is headquarteredin the UK and is listed on the London Stock Exchange (AIM:PLE) Furtherinformation is available at www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange