Plethora Solutions Holdings Plc Regulatory News (PLE)

21 Feb 2006 07:01

Plethora Solutions Holdings PLC21 February 2006 For Immediate Release 21 February 2006 SENETEK LICENSES INVICORP(R) ERECTILE DYSFUNCTION TREATMENT TO PLETHORA SOLUTIONS FOR NORTH AMERICA PLETHORA SOLUTIONS ASSUMES FULL REGULATORY RESPONSIBILITY AND RECEIVES OPTION ON ADDITIONAL TERRITORIES; SENETEK TO RECEIVE ROYALTIES AND MILESTONE PAYMENTS Senetek PLC (OTCBB: SNTKY), and Plethora Solutions (LSE:AIM : PLE) todayjointly announced the signing of an exclusive license for Plethora tomanufacture and market in North America Invicorp(R), Senetek's patentedcombination drug treatment for male erectile dysfunction (ED). Senetek is ahealthcare technologies company targeting the creation of products for theanti-aging market worldwide, and Plethora is an emerging specialtypharmaceutical company focused on the development and marketing of products forthe diagnosis, treatment and management of urological disorders. Under the terms of the license agreement, Plethora assumes full responsibilityfor the drug regulatory process for Invicorp(R) and for establishing thisimportant new therapy in the key North America market, which represents some 40%of global sales of erectile dysfunction treatments, and is granted options onadditional non-North American markets outside of the European Community. Senetekwill participate in the success of Invicorp through royalties based onPlethora's and its sub-licensees' net sales of Invicorp plus predeterminedmilestone payments upon achievement of regulatory approvals and cumulative netsales targets. Invicorp(R) and the erectile dysfunction market Invicorp(R) is Senetek's patented injectable combination of phentolaminemesylate and vasoactive intestinal polypeptide for the treatment of ED. Theproduct has already received marketing authorization in Denmark, which has beenchosen as the Reference Member State for the Mutual Recognition Procedure inEurope, as well as the UK. The prevalence of ED as reported in international surveys ranges from 10% to24%. ED prevalence increases with age and is almost threefold greater in menaged 70 or more than in men aged 40 to 49 years. Current pharmacotherapy for ED comprises of oral, injectable and transurethraltreatments. The common oral ED agents are contraindicated in patients takingnitrate medications for angina or certain drugs for the treatment of benignprostate hyperplasia (BPH). Also, their efficacy is reduced in patients withdiabetes and in those with nerve damage following prostate or pelvic surgery.Existing injectable and transurethral ED treatments are contraindicated inpatients with certain medical conditions. Invicorp, on the other hand, has adifferent mode of action to existing injectable and transurethral ED drugs andis not contraindicated in any patient population in those countries where itcurrently has marketing authorization. The product is self-administered using aconvenient microinjection system. Dr Mike Wyllie, Founder and Chief Scientific Officer of Plethora, remarked: "Invicorp(R) has great potential in the management of the large number ofpatients, e.g. diabetics, who have a poor or inadequate response to oral drugsand those patients who cannot safely take them. The latter category includes notonly nitrate users but also some patients taking common medications for thetreatment of benign prostatic hyperplasia (BPH). In this respect, like ourexisting Timm product line, Invicorp(R) could become an attractive treatmentoption for many patients". Frank J. Massino, Chairman and Chief Executive Officer of Senetek, commented:"This licensing agreement with Plethora Solutions marks a second major step inbringing this unique injectable formulation to a currently under-served patientpopulation. Finding an Invicorp commercial partner for the key North Americamarket that could give it the focus it deserves and the technical expertise anddistribution infrastructure to speed it to market was a key objective ofSenetek's 2006 business plan and Plethora Solutions is perfectly suited to thatrole. We are confident that our partnership with Plethora will allow Invicorp(R) to realize its full potential in the growing erectile dysfunction market.With this agreement in place, Senetek is ideally positioned to concentrate onits core business of expanding its portfolio of proprietary dermatologicals forthe global ethical pharmaceutical and cosmeceutical markets." Steven Powell, Chief Executive Officer of Plethora, commented: "Our recentacquisition of Timm Medical Technologies provides us with an establishedU.S.-focused urology sales and marketing capability. We are delighted to nowhave the opportunity to license rights to a pre-registration product which webelieve will make an important addition to our portfolio of products for thetreatment of male sexual dysfunction and which can be marketed, subject toachieving approval and registration, through our newly acquired field force.This confirms our previously stated objective to develop the Timm Medicalbusiness by leveraging its established sales force with new productopportunities." For further information contact: Plethora Solutions Tel : +44 (0)207 269 8630Steven Powell Buchanan Communications Tel : +44 (0)207 466 5000Tim Anderson, Isabel Podda Notes to Editor Senetek PLC is a life sciences-driven product development and licensing companyfocused on the high growth market for dermatological and skin care productsprimarily addressing photodamage and age-related skin conditions. Senetek'spatented compound Kinetin is a naturally occurring cytokinin that has proveneffective in improving the appearance of aging skin with virtually none of theside effects associated with acid-based active ingredients. Senetek haslicensed Kinetin to leading global and regional dermatological and skin caremarketers including Valeant Pharmaceuticals, The Body Shop and Revlon, andrecently announced the grant to Valeant Pharmaceuticals of an exclusive globallicense Zeatin, a promising analogue of Kinetin scheduled for launch early in2006. Senetek's researchers at the University of Aarhus, Denmark, also arecollaborating with the Institute of Experimental Botany, Prague, and withBeiersdorf AG, Hamburg, to identify and evaluate additional new biologicallyactive compounds for this high growth field. Senetek has developed its patentedInvicorp erectile dysfunction product, having started successful clinical trialsin Europe in 1991, gained marketing authorizations in Denmark, England and NewZealand, and exclusively licensed Invicorp to Ardana Bioscience for the EuropeanCommunity in 2003. www.senetekplc.com Senetek PLC Investor Relations Contact:1-707-226-3900 ext. 102E-mail: Pknopick@eandecommunications.com Plethora Solutions Holdings PLC is a UK-headquartered speciality pharmaceuticalcompany focused on the development of products for the treatment of urologicaldisease. It is listed on the Alternative Investment Market of the London StockExchange (AIM:PLE). The company has products in clinical development for thetreatment of overactive bladder, benign prostatic hyperplasia, stress urinaryincontinence, interstitial cystitis and premature ejaculation. In February 2006,Plethora acquired Minneapolis (Mn) based Timm medical Technologies Inc whichmarkets products for the treatment of erectile dysfunction (ED) to urologyclinics through a US-based speciality sales team. www.plethorasolutions.co.uk Safe Harbor Statement This news release contains statements that may be considered "forward-lookingstatements" within the meaning of the Private Securities Litigation Reform Act,including those that might imply Senetek's expectation that that Invicorp(R)will receive regulatory approvals in Europe for its marketing, and that PlethoraSolutions Ltd. will achieve commercial success with this product.Forward-looking statements by their nature involve substantial uncertainty, andactual results may differ materially from those that might be suggested by suchstatements. Important factors identified by the Company that it believes couldresult in such material differences are described in the Company's Annual Reporton Form 10-K for the year 2003. However, the Company necessarily can give noassurance that it has identified or will identify all of the factors that mayresult in any particular forward-looking statement materially differing fromactual results, and the Company assumes no obligation to correct or update anyforward-looking statements which may prove to be inaccurate, whether as a resultof new information, future events or otherwise This information is provided by RNS The company news service from the London Stock Exchange