Plethora Solutions Holdings Plc Regulatory News (PLE)

9 Oct 2006 07:00

Plethora Solutions Holdings PLC09 October 2006 PLETHORA SOLUTIONS HOLDINGS PLC Product Update Osbon ErecAid(R): FDA Allows Labeling for Use of ErecAid after Radical Prostate Surgery. Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,today announces that its Osbon ErecAid(R) product marketed through Plethora's USsubsidiary, Timm Medical, has received permission from the US FDA for extendedlabeling. This clarifies that the product may be used to create and maintainerections by providing arterial blood to the penis during recovery fromprostatectomy ("penile rehabilitation") and thus aid in maintaining preoperativesexual function. The Osbon ErecAid is the first device or drug to be cleared bythe FDA for this specific wider indication. Men treated for localised prostate cancer by either radical prostatectomy (RP)or radiotherapy can expect some degree of erectile dysfunction (ED) and thecondition may persist long into the recovery period. Prostate cancer screeninghas led to the detection of more cases in younger men and an increasing focus onrestoring sexual activity after treatment. According to the American CancerSociety, around 230,000 new cases of prostate cancer were diagnosed in theUnited States during 2005. The majority had localised (Stage II) disease atdiagnosis and between 25% and 30% of this patient group will be treated byradical prostatectomy, resulting in a potential penile rehabilitation treatmentpopulation of around 50,000 patients each year in the United States alone. ErecAid is already known to be highly effective in patients who either don'trespond to oral drugs, those who can not tolerate their side effects or in thosepatients who are precluded from using phosphodiesterase inhibitors, e.g. nitrateusers or patients with high cardiovascular risk. Impressive new clinicalevidence (Monga et al, World Congress of Endourology, August 2006) has helpedconvince the regulators that ErecAid can be of considerable benefit inmaintaining erectile function in men who experience erectile dysfunction afterprostate surgery, a situation where oral drugs may be of only limited use. The time from prostate surgery to restoration of normal sexual function may beup to two years, even with correctly applied nerve-sparing techniques.(i),(ii)Given the possible consequences of prolonged lack of erections and resultingpenile hypoxia, there has been an increased focus in recent years on so calledrehabilitation programmes to promote early nerve recovery following RP. "Theoverall concept of penile rehabilitation is to prevent cavernous tissue damagefrom occurring during neural recovery, by providing adequate arterial blood(oxygenation) to the erectile tissues." Encouraging results have beendemonstrated from use of the Osbon ErecAid, a vasoactive therapy.(iii),(iv) Intheir recent review, Kendirci et al. concluded that pharmacological penilerehabilitation protocols are beneficial after radical prostatectomy and that ".. .either intracavernous injections or a vacuum erection device can berecommended as a first-line option for the early post operative months, as theirmechanism of action does not require intact neural transmission." Previous studies have indicated that early penile rehabilitation can reduce theimpact of ED. Nerve damage after radical prostatectomy causes a loss of naturalnocturnal erections, reducing blood flow to the penis which causes fibrosis ofthe penile tissue, resulting in a reduction in penile length. Early penilerehabilitation is aimed at increasing blood flow to the penis so that the peniletissue is maintained while nerve function is restored. The efficacy of oral EDdrugs is greatly reduced in patients with nerve damage so alternative treatmentsare required. Mr. Roger Kirby, The Prostate Center, London commented "In situations where sexual function can be adversely affected by surgicalprocedures ErecAid would appear to have an important role in restoring potencyin a cost effective and timely manner". Dr Steven Powell, Plethora CEO, concluded: "The Osbon ErecAid is frequently prescribed for patients that are unable to usePDE-5 Inhibitors either because they are contraindicated, find the drug islimited in its effectiveness or because they cannot tolerate the associated sideeffects. This regulatory endorsement of the use of the Osbon ErecAid duringrecovery from prostatectomy provides physicians and their patients with a toolto fight the significant quality of life impact associated with prostatecancer". -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 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 (i) Walsh PC. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. J Urol2000; 164: 1929-1934.(ii) Burnett AL. Rationale for cavernous nerve restorative therapy to preserve erectile function after radical prostatectomy. Urology 2003; 61: 491-497(iii) Gontero P, Fontana F, Zitella A, et al. A prospective evaluation of efficacy and compliance with a multistep treatment approach for erectile dysfunction in patients after non-nerve sparing radical prostatectomy. BJU Int2005; 95: 359-365(iv) Raina R, Agarwal A, Allamaneni SS, et al. Sildenafil citrate and vacuum constriction device combination enhances sexual satisfaction in erectile dysfunction after radical prostatectomy. Urology2005; 65: 360-364. This information is provided by RNS The company news service from the London Stock Exchange