Plethora Solutions Holdings Plc Regulatory News (PLE)

26 Feb 2007 07:03

Plethora Solutions Holdings PLC26 February 2007 PLETHORA SOLUTIONS HOLDINGS PLC Clinical Update - PSD510 (Invicorp(R)) for erectile dysfunction Invicorp(R) advances to final stage of development Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialistdeveloper of products for the treatment and management of urological disordershas announced, following positive discussions with FDA, that it intends toinitiate the final component of the clinical development programme for Invicorp(R), a potential treatment for erectile dysfunction (ED). The phase IIIprogramme, in up to 30 sites in the US, is expected to commence in the 3rdquarter this year and is anticipated to take approximately 12 months tocomplete. Plethora licensed the exclusive North American rights to Invicorp(R) fromSenetek PLC (OTCBB:SNTKY) in 2006. Invicorp(R) is a patented injectablecombination of phentolamine mesilate and vasoactive intestinal polypeptide.Published clinical data indicate that the efficacy and local tolerabilityprofile of Invicorp(R) compare favourably with current non-oral drug treatmentoptions for the treatment of ED. The product has marketing authorisation inDenmark and was launched there in September 2006. Invicorp(R) has also beenapproved in the UK and New Zealand. The ED market is dominated by the oral phosphodiesterase (PDE5) inhibitor drugs.Although these are reported to be effective in around 70% of ED patients, oralED drugs cannot be taken by men who require nitrate medications for angina andtheir effectiveness is substantially reduced in diabetic patients and in thoserecovering from prostate cancer or pelvic surgery. Plethora estimates that thereare over 5.9 million men in the US alone for whom oral ED drugs are not a viabletreatment option. Non-oral ED drug sales exceeded $31 million in the US in 2005(IMS data). Upon approval, Invicorp(R) could be the first novel non-oral EDtreatment to enter the North American market in over a decade. Professor Tom Lue (Vice-Chair of Urology, UCSF and President of the SexualMedicine Society of North America) commented, "The arrival of Invicorp(R) intothe US market should make an invaluable addition to our therapeuticarmamentarium for many men. In particular those individuals for whomphosphodiesterase inhibitors give an unsatisfactory response or arecontra-indicated and for those who like the quality of erection and the speed ofonset of an injectable". Dr. Mike Wyllie, Plethora CSO, commented: "Once again this re-enforces the valueof the Plethora approach of developing products with large existing safetydatabases, facilitating a relatively rapid track to registration. Although thereare marketed products in this segment of the ED market, we believe that Invicorp(R) has key points of differentiation. Invicorp(R) injection is essentially painfree whereas the marketed products have been shown to producecompliance-limiting pain on administration in over 30% of men". Frank Massino (CEO, Senetek) stated "We are extremely encouraged at the speedwith which Plethora is moving Invicorp(R) towards the US market. Leading marketresearchers have continually reported that physicians eagerly await theavailability of this product in the United States". -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 This information is provided by RNS The company news service from the London Stock Exchange