Plethora Solutions Holdings Plc Regulatory News (PLE)

22 Feb 2007 07:02

Plethora Solutions Holdings PLC22 February 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD502 for premature ejaculation IND application advances PSD502 to final stage of development Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disorders,has announced that it has filed an Investigational New Drug (IND) applicationwith the FDA to initiate the final phase of clinical development of PSD502, aproduct for the treatment of premature ejaculation. This follows positiveoutcomes from meetings with regulatory authorities in both the USA (FDA) andEurope (MHRA) which have defined the clinical development programme required totake this project to marketing authorisation. As announced previously, Plethora is in the advanced stage of partneringdiscussions for PSD502. Having reviewed the PSD502 development plans withpotential development and marketing partners, Plethora has now completed itsfiling with the FDA ahead of moving the product into Phase III once partneringagreements have been concluded. This is another key step towards the commercialisation of PSD502 and follows therecent conclusion of a manufacturing and supply agreement between the companyand Inyx Inc of New York, USA. Under the terms of this agreement, Plethora hassecured supply of PSD502 both for the Phase III study and any subsequentpotential commercial requirements. PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the USA and for which there is no approved treatment. The product is applied locallywhen needed (often referred to as "on demand" therapy) and is effective within five minutes. Other key advantages of the product are a minimal risk of safety issues, minimal partner transfer eliminating the need to use a condom and the potential for the dose to be self titrated or adjusted under physician direction. The product was shown to increase ejaculation latency time substantially when compared with placebo in a multi-centre Phase II study. Thisdata has been published recently in BJU International (Dinsmore W et al 2007 BJU int 99: 369-35) The programme to secure product registration in the USA and Europe will involveless than 600 patients and could be completed within 15 months. This residualdevelopment programme reflects both the excellent efficacy data generated byPlethora to date and the extensive historical clinical safety database availableon the components of PSD 502. The suitability of this development programme hasbeen confirmed via recent meetings with the FDA and the European authorities(MHRA). The design and structure of the Phase III study has also been discussedextensively with potential marketing partners. The combined worldwide Phase IIIprogramme will involve in the region of 20 European and 20 North Americancentres and will be supported by Plethora and its future development marketingpartners. Professor Culley Carson of the University of North Carolina and a past presidentof the Sexual Medicine Society of North America (SMSNA) stated "The fact theregulatory authorities require relatively little additional safety data wouldappear to vindicate Plethora's approach of using a product that does not resultin systemic exposure. Given the proposed track of the programme, welcome relieffor the many hundreds of thousands of PE sufferers is in sight at last." Steven Powell, Plethora CEO, concluded: "We are pleased to be advancing PSD502 into the final phase of clinicaldevelopment for treatment of premature ejaculation. With the relatively shortdevelopment path to registration and the proximity to securing partneringagreements these are exciting times for Plethora". -Ends- For further information contact: Plethora Solutions Tel : 020 7269 8630Steven PowellCity/Financial Enquiries Tel: 020 7379 5151 MaitlandBrian 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 This information is provided by RNS The company news service from the London Stock Exchange