Plethora Solutions Holdings Plc Regulatory News (PLE)

30 Oct 2007 12:30

Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialtypharmaceutical company, and Plethora Solutions Holdings PLC("Plethora") (AIM:PLE), the specialist developer of products for thetreatment and management of urological disorders, today jointlyannounced that they have initiated patient enrollment for the PhaseIII clinical trials in the U.S. for PSD502 for the treatment ofpremature ejaculation. In May 2007, Sciele signed an exclusivelicensing agreement for PSD502 with Plethora Solutions. £ PSD502 is a proprietary formulation of two marketed drugs -lidocaine and prilocaine - dispensed by a metered dose aerosol anddeveloped for the treatment of premature ejaculation, a disorderaffecting up to 30% of men in Europe and the U.S. and for which therecurrently is no FDA-approved prescription treatment. The product isapplied locally when needed (often referred to as "on demand" therapy)and is effective within five minutes. The product has been shown toincrease ejaculation latency time substantially when compared withplacebo in a multi-center Phase II study. This data was publishedrecently in BJU International (Dinsmore W et al 2007,BJU Int 99: 369-35). £ Patrick Fourteau, President and Chief Executive Officer of ScielePharma, said, "We are pleased with the excellent progress Plethora hasmade with the development of PSD502, initiating the Phase III pivotaltrials within our previously announced timelines. PSD502 for prematureejaculation addresses an unmet medical need that affects a significantnumber of adult males in all age groups." £ Steven Powell, Chief Executive Officer of Plethora, commented, "Weare pleased to be advancing PSD502 into the final stage of clinicaldevelopment for the treatment of premature ejaculation. If patientrecruitment proceeds as planned, we would expect to see headline datatowards the end of 2008 which will be a major milestone in the life ofboth this product and Plethora." £ Study Details: £ Plethora intends to run the two pivotal studies in parallel, onein the U.S. and one in Europe. Each will be a multi-center,randomized, double-blind, placebo-controlled efficacy study recruitinga total of 540 patients across both studies. Patients will be treatedfor a 12-week period with an optional five-month open-label phase. Theprimary endpoints will be Intra-vaginal Ejaculation Latency Time(IVELT), sexual satisfaction and ejaculatory control. Secondaryendpoints will include Sexual Quality of Life and partnersatisfaction. The study design and powering, in agreement with bothU.S. and E.U. regulatory authorities, employ validated patientreported outcomes (PROs). The two studies will recruit patients in 36centers in Europe and 38 in the U.S. and Canada, including almost allNorth American opinion leaders. It also has been agreed with theregulators that one-year open-label extensions to the studies are notrequired, which will reduce time to study closure considerably. £ About Plethora Solutions £ Plethora is focused on the development and marketing of productsfor the treatment of urological disorders. The Company has products inclinical development for the treatment of overactive bladder, stressurinary incontinence, interstitial cystitis, gynecological pain andpremature ejaculation. In January 2006, Plethora acquired Minneapolis(MN) based Timm Medical Technologies, Inc. which markets theErecAid(R) and Rigiscan(R) products for the treatment of erectiledysfunction (ED) to urology clinics through a US-based specialty salesteam. Most recently, the ErecAid has been found to be effective formen that fail Medical Management and for men recovering fromprostatectomy. The Company is headquartered in the UK and is listed onthe London Stock Exchange (AIM:PLE) Further information is availableat www.plethorasolutions.co.uk £ About Sciele Pharma, Inc. £ Sciele Pharma, Inc. is a pharmaceutical company specializing insales, marketing and development of branded prescription productsfocused on Cardiovascular/Metabolic, Women's Health and Pediatrics.The Company's Cardiovascular/Metabolic products treat patients withhigh cholesterol, hypertension, high triglycerides, unstable anginaand Type 2 diabetes; its Women's Health products are designed toimprove the health and well-being of women and mothers and theirbabies; and its Pediatrics products treat allergies, asthma, coughsand colds, and attention deficit/hyperactivity disorder (ADHD).Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharmaemploys more than 900 people. The Company's success is based onplacing the needs of patients first, improving health and quality oflife, and implementing its business platform - an EntrepreneurialSpirit, Innovation, Speed of Execution, Simplicity, and Teamwork. £ Safe Harbor Statement £ This press release contains forward-looking statements that aresubject to risks and uncertainties that could cause actual results tomaterially differ from those described. Although we believe that theexpectations expressed in these statements are reasonable, we cannotpromise that our expectations will turn out to be correct. Our actualresults could be materially different from and worse than ourexpectations. With respect to such forward-looking statements, we seekthe protections afforded by the Private Securities Litigation ReformAct of 1995. These risks include, without limitation: £ We may not attain expected revenues and earnings. If we areunsuccessful in obtaining third party payor contracts for ourproducts, we may experience reductions in sales levels and may fail toreach anticipated sales levels. If demand for our products exceeds ourinitial expectations or the ability of our suppliers to providedemand-meeting quantities of product and samples, our ability to sellthese products could be adversely impacted. The potential growth ratefor our promoted products may be limited by slower growth for theclass of drugs to which our promoted products belong and unfavorableclinical studies about such class of drugs. We may encounter problemsin the manufacture or supply of our products, for which we dependentirely on third parties. £ Strong competition exists in the sales of our promoted products,which could adversely affect the expected growth of our products'sales or increase our selling costs. We may not be able to protect ourcompetitive position for our promoted products from infringers. £ Altoprev has experienced manufacturing issues; if the issues recurand cannot be resolved, our ability to acquire the product for saleand sampling will be adversely affected. Sales of our Robinul producthave been adversely affected by the introduction of knock-off andgeneric product. £ We may incur unexpected costs in integrating new products into ouroperations. If we have difficulties acquiring new products or rightsto market new products from third parties, our financial results couldbe adversely impacted. We may be unable to develop or market lineextensions for our products including Sular, Triglide, Fortamet, andour Prenate Line or, even if developed, obtain patent protection forour line extensions. Further, introductions by us of line extensionsof our existing products may require us to make unexpected changes inour estimates for future product returns and reserves for obsoleteinventory. If these risks occur, our operating results would beadversely affected. Our licensor/supplier can terminate our rights tocommercialize Nitrolingual and the 60 dose size of this product hasnot yet met our expectation. Our new Sular formulation is presentlyundergoing clinical trial testing. There can be no assurance that thetrial results will be positive, and if they are not, we may not beable to market and sell our new Sular formulation. £ We depend on a small senior management group, the departure of anymember of which would likely adversely affect our business. An adverseinterpretation or ruling by one of the taxing jurisdictions in whichwe operate could adversely impact our operating results. A smallnumber of customers account for a large portion of our sales and theloss of one of them, or changes in their purchasing patterns, couldresult in substantially reduced sales and adversely impact ourfinancial results. If third-party payors do not adequately reimbursepatients for our products, doctors may not prescribe them. Further,our business is subject to increasing government price controls andother healthcare cost-containment measures. Side effects or marketingor manufacturing problems with our products could result in productliability claims which could be costly to defend and could result inthe withdrawal or recall of products from the market. £ We rely on operational data obtained from IMS, an industryaccepted data source. IMS data may not accurately reflect actualprescriptions (for instance, we believe IMS data does not capture allproduct prescriptions from some non-retail channels). An adversejudgment in the securities class action litigation in which we andcertain current and former directors and executive officers aredefendants could have a material adverse effect on our results ofoperations and liquidity. £ If we fail to obtain, or encounter difficulties in obtaining,regulatory approval for new products or new uses of existing products,or if our development agreements are terminated, we will have expendedsignificant resources for no return. Our business and products arehighly regulated. The regulatory status of some of our products makesthese products subject to increased competition and other risks, andwe run the risk that we, or third parties on whom we rely, couldviolate the governing regulations; if generic competitors that competewith any of our products are introduced, our revenues may be adverselyaffected. £ Some unforeseen difficulties may occur. £ The above are some of the principal factors that could causeactual results to differ materially from those described in theforward-looking statements included above. These factors are notintended to represent a complete list of all risks and uncertaintiesinherent in our business, and should be read in conjunction with themore detailed cautionary statements and risk factors included in ourother filings with the Securities and Exchange Commission. Copyright Business Wire 2007