Plethora Solutions Holdings Plc Regulatory News (PLE)

4 Apr 2006 07:01

Plethora Solutions Holdings PLC04 April 2006 For Immediate Release 4 April 2006 PLETHORA SOLUTIONS HOLDINGS PLC Preliminary Results FOR THE YEAR ENDED 31 December 2005 Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), aUK-based speciality pharmaceutical company, is pleased to announce itspreliminary results for the year ended 31 December 2005. A summary of key pointsfollows: Highlights Operations • PSD502: Successful completion of a Phase II clinical study demonstrating a positive clinical effect for treatment of premature ejaculation. Out-licensing discussions are progressing with a number of leading pharmaceutical companies • New clinical programme initiated to develop PSD502 in a second indication for treatment of wound and burn pain • PSD401: Development agreement signed with Johnson & Johnson • PSD503: Progression into a full Phase II clinical study for treatment of stress urinary incontinence • PSD506: In-license of potential treatment for overactive bladder from F.Hoffman-La Roche • PSD597: In-license of potential treatment for interstitial cystitis from Queen's University, Kingston, Ontario • Acquisition of Timm Medical Technologies, Inc., post reporting period, providing a North American sales and marketing operation with approved products for treatment of erectile dysfunction Financial • Successful admission to AIM in March 2005 raising £ 8.9m net of expenses • Placing raising £6.3 million in January 2006 primarily to finance acquisition of Timm Medical Technologies, Inc. (post reporting period) • Loss for 2005 of £ 5.4m in line with expectations • R&D expenses include a pre-placing license fee payment to Roche in relation to PSD506 of £1.6 million. Operating costs were, therefore, £3.8m • Year end cash of £6.2m provides sufficient funds to progress expanded pipeline to licensing points at end of Phase II • Acquisition of Timm Medical Technologies, Inc. post reporting period, strengthens financial position further Stuart Wallis, Chairman of Plethora, commented: "2005 was an extremely exciting year for Plethora during which we took majorstrides towards our goal of becoming a leading force in urology. We haveannounced major developments in our pipeline demonstrating considerable progresswith our original drug development programmes whilst expanding the pipeline withthe addition of new products with significant market potential. "Following the positive outcome of the Phase II study of PSD502 for thetreatment of premature ejaculation we expect that this project will be licensedto a marketing partner in mid 2006. With this and the establishment of anexciting franchise in erectile dysfunction (ED) through the acquisition of TimmMedical Technologies and North American rights to an injectible treatment forED, Invicorp(R), we have moved into 2006 with a solid and extensive productplatform and an expectation of delivering positive and consistent news fromacross our portfolio as we progress through this next year. We look forward toupdating shareholders on our progress." For additional information contact: Plethora Solutions Tel : 020 7269 8630 Steven Powell, Chief Executive OfficerBrad Hoy, Chief Financial Officer Collins Stewart Tel : 020 7523 8350 Tim Mickley Buchanan Communications Tel : 020 7466 5000 Isabel Podda Notes to Editor Plethora is focused on the development and marketing of products for thetreatment of urological disorders. Since its foundation, the Group has built anextensive pipeline of clinical development programmes for treatment ofoveractive bladder, stress urinary incontinence, interstitial cystitis andpremature ejaculation together with a late stage, pre-registration drug,Invicorp(R), for the treatment of erectile dysfunction. In January 2006,Plethora acquired Minneapolis (Mn) based Timm Medical Technologies, Inc., aprofitable sales and marketing operation with its own field sales forcemarketing directly to urology clinics. The Company is headquartered in the UKand is listed on the London Stock Exchange (AIM:PLE) Further information isavailable at www.plethorasolutions.co.uk Chief Executive's Review In 2005 we concentrated our activities on building an extensive developmentpipeline of products for the treatment of urological conditions and drivingvalue by moving products through clinical trials. Since our flotation in March2005 we have completed a Phase II trial for one of our products, commenced PhaseII trials on two further products as well as introducing marketed products forthe treatment of erectile dysfunction to the Plethora portfolio. Having established this solid platform, our primary goal for 2006 will be togenerate value by driving projects forward and establishing revenue generatingcommercial partnerships, leading off with PSD502. PREMATURE EJACULATION Premature ejaculation (PE) is the most commonly reported form of male sexualdysfunction, afflicting 25 to 30% of men in the US and Europe. We estimate thatthere are over 25 million married men in North America and the major Europeannations alone who suffer from PE. No pharmaceutical treatments are approved forPE. PSD502 Plethora's development product for the treatment of PE, PSD502, is a proprietaryformulation of two local anaesthetics, lidocaine and prilocaine, dispensed bymetered dose aerosol. Application to the glans of the penis just prior tointercourse results in prolongation of time to ejaculation. The productrepresents a convenient, on-demand therapy with a minimal risk of druginteraction or any other safety issues. In December 2005, we were delighted to report that PSD502 had successfullycompleted a double-blind, placebo-controlled parallel group Phase II clinicalstudy conducted in subjects with primary PE. A baseline intravaginal ejaculationlatency time (IELT: the time to ejaculation from penetration) was establishedfor each subject and the IELT scores determined after application of eitherPSD502 or a placebo spray. Results obtained for 43 evaluable subjects showed astatistically-significant (p