Plethora Solutions Holdings Plc Regulatory News (PLE)

27 Nov 2006 07:01

Plethora Solutions Holdings PLC27 November 2006 PLETHORA SOLUTIONS HOLDINGS PLC Product Update PSD401 - Sexual Activity Monitor (SAMTM) Plethora Enters Into Agreement with Global Pharmaceutical Company Plethora Solutions Holdings plc ("Plethora" or the "Company", AIM : PLE), thespecialist developer of products for the treatment and management of urologicaldisorders, today announces that it has entered into an agreement with a majormulti-national pharmaceutical company to supply Plethora's Sexual AssessmentMonitor (SAMTM, PSD401), a device for the measurement and automated recording ofejaculation time, into a clinical programme using time to ejaculation as aprimary endpoint. The use of PSD401 to measure time to ejaculation introduces anew level of accuracy over the traditional method of measurement using a handheld stop watch. A similar agreement was entered into with Johnson & Johnson in2005. Plethora recently published the successful conclusion of development trials onPSD401. (Dinsmore et al (2006) BJU Int, 98; 613-61). These trials, monitoringboth healthy volunteers and patients suffering from Premature Ejaculation (PE),established the reproducibility, efficacy and safety of the product and theability to discriminate between healthy patients with "normal" latency times andPE sufferers. Dr. Mike Wyllie, CSO of Plethora, commented; "We are delighted that anotherleading pharmaceutical company has selected PSD401 for use in their developmentof treatments for sexual dysfunction. This second agreement demonstrates clearlythat PSD401 can be a valuable aid to clinical development within majorpharmaceutical companies and is a key component in our commercialisation of theproduct." As well as working with pharmaceutical companies that utilise the product inclinical development and marketing programmes for drugs for the treatment of PE,PSD401 will ultimately be used by the urologists, andrologists, other relevantspecialists and primary care physicians who are responsible for the diagnosisand management of the large PE patient population. For this purpose, Plethorahas obtained both European and US marketing approval for the device, which willbe marketed through its subsidiary, Timm Medical. The recent 510K approval formarketing of the device should also expedite acceptance in the US as a frontline diagnostic system. In this context, many of the key sexual health opinionleaders in the USA are to take delivery of PSD401s in Q1 2007 In the expanding sexual health market, PSD401 complements Plethora's therapeuticproduct PSD502 for the treatment of PE which is about to enter phase IIIclinical trials once on-going partnering discussions are finalised. -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell City/Financial Enquiries Tel: 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel: 020 7861 3838DeFacto CommunicationsRichard Anderson More about PSD401: PSD401 is a diagnostic device designed for use either in urology clinics,physicians' offices or in "at home" situations to quantify ejaculation latencytime. Demand for such a system was based on market analysis of the requirementsof US physicians and US and European regulators and the knowledge that severalnew drugs for PE are in advanced stages of clinical development. Despite thelarge patient population, there is no validated technique for either diagnosingPE or assessing and comparing treatments for PE. This is an issue given thenumber of treatments for PE at various stages of clinical development and notunexpectedly regulatory authorities are applying pressure for a standardiseddiagnostic device for use in such trials. Given the need for definitive andreproducible endpoints in clinical trials, the existing approach to quantitativediagnosis of PE of a patient-operated stopwatch to measure intravaginalejaculation time (IELT) has inherent problems with compliance and reproducibility. About Plethora: Plethora is focused on the development and marketing of products for thetreatment of urological disorders. The Company has products in clinicaldevelopment for the treatment of overactive bladder, stress urinaryincontinence, interstitial cystitis, gynaecological pain and prematureejaculation. In January 2006, Plethora acquired Minneapolis (Mn) based TimmMedical Technologies Inc which markets products for the treatment of erectiledysfunction (ED) to urology clinics through a US-based specialty sales team. TheCompany is headquartered in the UK and is listed on the London Stock Exchange(AIM:PLE) Further information is available at www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange