Plethora Solutions Holdings Plc Regulatory News (PLE)

24 May 2007 07:03

Plethora Solutions Holdings PLC24 May 2007 Plethora Enters Into Exclusive License Agreement with Sciele to Market PSD502 for the Treatment of Premature Ejaculation Sciele Pharma to Purchase $7 Million Equity Stake in Plethora ATLANTA, LONDON (May 24, 2007) Sciele Pharma, Inc. (NASDAQ:SCRX) and PlethoraSolutions Holdings plc ("Plethora", AIM:PLE) announced today that they havesigned an exclusive license agreement for the marketing of PSD502 for prematureejaculation (PE) in the United States together with an agreement for Sciele topurchase a $7 million equity stake in Plethora. Plethora is developinginnovative products for women's health and male sexual dysfunction. Plethora hasproducts in clinical development for the treatment of premature ejaculation,overactive bladder, stress urinary incontinence, interstitial cystitis andgynecological pain. Under the terms of the license agreement, Plethora will receive payments uponachievement of regulatory and sales milestones, and royalty payments on productsales. Plethora will have co-promotion rights for urologists in the UnitedStates. PE is the most common form of sexual dysfunction among men. PE is estimated toaffect approximately 25% to 30% of men of all ages (Laumann et al1999 JAMA281537-44). According to the results of this survey, approximately 25 millionmen between the ages of 18 and 59 in the U.S. experience PE. PSD502 comprises a unique, proprietary, and rapidly absorbed formulation of twowell-established local anesthetics, lidocaine and prilocaine, dispensed in ametered dose spray. Plethora has completed a phase II clinical trial usingPSD502, and Plethora is expected to begin a phase III study in the second halfof 2007. Under the agreement to purchase a $7 million equity stake in Plethora, Scielehas purchased 1,772,505 new Ordinary Shares in Plethora at £2.00 per share. Patrick Fourteau, Chief Executive Officer of Sciele, said, "We are pleased totake an equity stake and enter into this collaboration with Plethora as they aredeveloping new products for Women's Health and sexual dysfunction. Thispartnership will enable us to further expand our product pipeline and leverageour sales force. We are enthusiastic about PSD502, which may provide a potentialPE treatment, addressing an unmet medical need for millions of men." Steven Powell, Chief Executive Officer of Plethora, said, "We are delighted tohave Sciele as a licensing partner and welcome them as a shareholder. We lookforward to working with Sciele and to updating our shareholders on progress withlicensing PSD502 for premature ejaculation elsewhere in territories outside theUSA." About Plethora Solutions: 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, gynecological pain and prematureejaculation. In January 2006, Plethora acquired Minneapolis (MN) based TimmMedical Technologies, Inc. which markets the ErecAid(R) and Rigiscan(R) productsfor the treatment of erectile dysfunction (ED) to urology clinics through aUS-based specialty sales team. Most recently, the ErecAid has been found to beeffective for men that fail Medical Management and for men recovering fromprostatectomy The Company is headquartered in the UK and is listed on the LondonStock Exchange (AIM:PLE) Further information is available atwww.plethorasolutions.co.uk About Sciele Pharma, Inc. Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketingand development of branded prescription products focused on Cardiovascular/Diabetes and Women's Health. The Company's Cardiovascular/Diabetes productstreat patients with high cholesterol, hypertension, high triglycerides, unstableangina and Type 2 diabetes, and its Women's Health products are designed toimprove the health and well-being of women and mothers and their babies. Foundedin 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than800 people. The Company's success is based on placing the needs of patientsfirst, improving health and quality of life, and implementing its businessplatform - an Entrepreneurial Spirit, Innovation, Speed of Execution,Simplicity, and Teamwork. Safe Harbor Statement This press release contains forward-looking statements that are subject to risksand uncertainties that could cause actual results to materially differ fromthose described. Although we believe that the expectations expressed in thesestatements are reasonable, we cannot promise that our expectations will turn outto be correct. Our actual results could be materially different from and worsethan our expectations. With respect to such forward-looking statements, we seekthe protections afforded by the Private Securities Litigation Reform Act of1995. These risks include, without limitation: We may not attain expected revenues and earnings. If we are unsuccessful inobtaining third party payor contracts for our products, we may experiencereductions in sales levels and may fail to reach anticipated sales levels. Ifdemand for our products exceeds our initial expectations or the ability of oursuppliers to provide demand-meeting quantities of product and samples, ourability to sell these products could be adversely impacted. The potential growthrate for our promoted products may be limited by slower growth for the class ofdrugs to which our promoted products belong and unfavorable clinical studiesabout such class of drugs. We may encounter problems in the manufacture orsupply of our products, for which we depend entirely on third parties.Strong competition exists in the sales of our promoted products, which couldadversely affect the expected growth of our products' sales or increase ourselling costs. We may not be able to protect our competitive position for ourpromoted products from infringers. Altoprev has experienced manufacturing issues; if the issues recur and cannot beresolved, our ability to acquire the product for sale and sampling will beadversely affected. Sales of our Robinul product have been adversely affected bythe introduction of knock-off and generic product. We may incur unexpected costs in integrating new products into our operations.If we have difficulties acquiring new products or rights to market new productsfrom third parties, our financial results could be adversely impacted. We may beunable to develop or market line extensions for our products including Sular,Triglide, Fortamet, and our Prenate Line or, even if developed, obtain patentprotection for our line extensions. Further, introductions by us of lineextensions of our existing products may require us to make unexpected changes inour estimates for future product returns and reserves for obsolete inventory. Ifthese risks occur, our operating results would be adversely affected. Ourlicensor/supplier can terminate our rights to commercialize Nitrolingual and the60 dose size of this product has not yet met our expectation. Our new Sularformulation is presently undergoing clinical trial testing. There can be noassurance that the trial results will be positive, and if they are not, we maynot be able to market and sell our new Sular formulation. We depend on a small senior management group, the departure of any member ofwhich would likely adversely affect our business. An adverse interpretation orruling by one of the taxing jurisdictions in which we operate could adverselyimpact our operating results. A small number of customers account for a largeportion of our sales and the loss of one of them, or changes in their purchasingpatterns, could result in substantially reduced sales and adversely impact ourfinancial results. If third-party payors do not adequately reimburse patientsfor our products, doctors may not prescribe them. Further, our business issubject to increasing government price controls and other healthcarecost-containment measures. Side effects or marketing or manufacturing problemswith our products could result in product liability claims which could be costlyto defend and could result in the withdrawal or recall of products from themarket. We rely on operational data obtained from IMS, an industry accepted data source.IMS data may not accurately reflect actual prescriptions (for instance, webelieve IMS data does not capture all product prescriptions from some non-retailchannels). An adverse judgment in the securities class action litigation inwhich we and certain current and former directors and executive officers aredefendants could have a material adverse effect on our results of operations andliquidity. If we fail to obtain, or encounter difficulties in obtaining, regulatoryapproval for new products or new uses of existing products, or if ourdevelopment agreements are terminated, we will have expended significantresources for no return. Our business and products are highly regulated. Theregulatory status of some of our products makes these products subject toincreased competition and other risks, and we run the risk that we, or thirdparties on whom we rely, could violate the governing regulations; if genericcompetitors that compete with any of our products are introduced, our revenuesmay be adversely affected. Some unforeseen difficulties may occur.The above are some of the principal factors that could cause actual results todiffer materially from those described in the forward-looking statementsincluded above. These factors are not intended to represent a complete list ofall risks and uncertainties inherent in our business, and should be read inconjunction with the more detailed cautionary statements and risk factorsincluded in our other filings with the Securities and Exchange Commission. Contact: Sciele Pharma, Inc.Joseph T. Schepers, 678-341-1401ir@sciele.com or Plethora SolutionsSteven Powell, 020 7269 8630 or City/Financial Enquiries - PlethoraMaitlandBrian Hudspith/Liz Morley, 020 7379 5151 or Scientific/Trade Press Enquiries - PlethoraDeFacto CommunicationsRichard Anderson, 020 7861 3838 This information is provided by RNS The company news service from the London Stock Exchange