Plethora Solutions Holdings Plc Regulatory News (PLE)

13 Jul 2005 07:00

Plethora Solutions Holdings PLC13 July 2005 For immediate release 13 July 2005 PLETHORA SOLUTIONS HOLDINGS PLC PSD401 - Sexual Activity Monitor (SAM) Collaborative Agreement with Johnson and Johnson Pharmaceutical Research LLC Plethora Solutions Holdings PLC ("Plethora" or the "Company", AIM : PLE), ispleased to announce that it has entered into an agreement with Johnson & JohnsonPharmaceutical Research & Development LLC (J&J) to perform a clinical programmeincorporating the use of Plethora's Sexual Assessment Monitor (PSD401) as aprimary endpoint. PSD 401 is a device for the measurement and automatedrecording of ejaculation time which has been traditionally measured using a handheld stop watch. Plethora recently announced the successful conclusion of development trials onPSD401. These trials, monitoring both healthy volunteers and patients sufferingfrom Premature Ejaculation (PE), established the reproducibility, efficacy andsafety of the product and the ability to discriminate between healthy patientswith "normal" latency times and PE sufferers. The aim of the collaborative studywith J&J is to define the site of action of agents that prolong ejaculationlatency. As well as working with pharmaceutical companies, such as J&J, to utilise theproduct in clinical development and marketing programmes for drugs for thetreatment of PE, Plethora has also initiated discussions with potentialmarketing and distribution partners who will target the urologists,andrologists, other relevant specialists and primary care physicians who will beresponsible for the management of the large PE patient population. In the expanding sexual health market, PSD401 complements Plethora's therapeuticproduct PSD502 for the treatment of PE which is currently undergoing Phase IIclinical trials. Steven Powell, CEO of Plethora, commented; "We are delighted that J&J, a leaderin development of therapeutics for the treatment of premature ejaculation, haschosen to incorporate PSD401 into this important programme. This demonstratesthat PSD401 can be an important aid to clinical development and marketing of PEdrugs and is a key step in our commercialisation of the product." For further information contact: Steven PowellPlethora Solutions Tel : 0207 269 8630 Tim MickleyCollins Stewart Tel : 0207 523 8350 Tim Anderson, Isabel PoddaBuchanan Communications Tel : 0207 466 5000 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 andreproducibility. About Plethora: Plethora is a UK-based speciality pharmaceutical company focused on thedevelopment of products for the treatment of urological disease. The company hasproducts in clinical development for the treatment of overactive bladder, benignprostatic hyperplasia, stress urinary incontinence and premature ejaculation.The company is headquartered in the UK and recently listed on the London StockExchange (PLE:LN) This information is provided by RNS The company news service from the London Stock Exchange