Plethora Solutions Holdings Plc Regulatory News (PLE)

24 May 2007 13:00

Sciele Pharma, Inc. (NASDAQ:SCRX) and Plethora Solutions Holdingplc ("Plethora") (AIM:PLE) announced today that they have signed anexclusive license agreement for the marketing of PSD502 for prematureejaculation (PE) in the United States together with an agreement forSciele to purchase a $7 million equity stake in Plethora. Plethora isdeveloping innovative products for women's health and male sexualdysfunction. Plethora has products in clinical development for thetreatment of premature ejaculation, overactive bladder, stress urinaryincontinence, interstitial cystitis and gynecological pain. £ Under the terms of the license agreement, Plethora will receivepayments upon achievement of regulatory and sales milestones, androyalty payments on product sales. Plethora will have co-promotionrights for urologists in the United States. £ PE is the most common form of sexual dysfunction among men. PE isestimated to affect approximately 25% to 30% of men of all ages(Laumann et al 1999 JAMA 281 537-44). According to the results of thissurvey, approximately 25 million men between the ages of 18 and 59 inthe U.S. experience PE. £ PSD502 comprises a unique, proprietary, and rapidly absorbedformulation of two well-established local anesthetics, lidocaine andprilocaine, dispensed in a metered dose spray. Plethora has completeda phase II clinical trial using PSD502, and Plethora is expected tobegin a phase III study in the second half of 2007. £ Under the agreement to purchase a $7 million equity stake inPlethora, Sciele has purchased 1,772,505 new Ordinary Shares inPlethora at GBP 2.00 per share. £ Patrick Fourteau, Chief Executive Officer of Sciele, said, "We arepleased to take an equity stake and enter into this collaboration withPlethora as they are developing new products for Women's Health andsexual dysfunction. This partnership will enable us to further expandour product pipeline and leverage our sales force. We are enthusiasticabout PSD502, which may provide a potential PE treatment, addressingan unmet medical need for millions of men." £ Steven Powell, Chief Executive Officer of Plethora, said, "We aredelighted to have Sciele as a licensing partner and welcome them as ashareholder. We look forward to working with Sciele and to updatingour shareholders on progress with licensing PSD502 for prematureejaculation elsewhere in territories outside the USA." £ 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/Diabetes and Women's Health. The Company'sCardiovascular/Diabetes products treat patients with high cholesterol,hypertension, high triglycerides, unstable angina and Type 2 diabetes,and its Women's Health products are designed to improve the health andwell-being of women and mothers and their babies. Founded in 1992 andheadquartered in Atlanta, Georgia, Sciele Pharma employs more than 800people. The Company's success is based on placing the needs ofpatients first, improving health and quality of life, and implementingits business platform - an Entrepreneurial Spirit, Innovation, Speedof 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