ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc. (NASDAQ:SCRX - News) and Plethora Solutions Holding plc (“Plethora”) (AIM:PLE) announced today that they have signed an exclusive license agreement for the marketing of PSD502 for premature ejaculation (PE) in the United States together with an agreement for Sciele to purchase a $7 million equity stake in Plethora. Plethora is developing innovative products for women’s health and male sexual dysfunction. Plethora has products in clinical development for the treatment of premature ejaculation, overactive bladder, stress urinary incontinence, interstitial cystitis and gynecological pain.
Under the terms of the license agreement, Plethora will receive payments upon achievement of regulatory and sales milestones, and royalty payments on product sales. Plethora will have co-promotion rights for urologists in the United States.
PE is the most common form of sexual dysfunction among men. PE is estimated to affect approximately 25% to 30% of men of all ages (Laumann et al 1999 JAMA 281 537-44). According to the results of this survey, approximately 25 million men between the ages of 18 and 59 in the U.S. experience PE.
PSD502 comprises a unique, proprietary, and rapidly absorbed formulation of two well-established local anesthetics, lidocaine and prilocaine, dispensed in a metered dose spray. Plethora has completed a phase II clinical trial using PSD502, and Plethora is expected to begin a phase III study in the second half of 2007.
Under the agreement to purchase a $7 million equity stake in Plethora, Sciele has purchased 1,772,505 new Ordinary Shares in Plethora at GBP 2.00 per share.
Patrick Fourteau, Chief Executive Officer of Sciele, said, “We are pleased to take an equity stake and enter into this collaboration with Plethora as they are developing new products for Women’s Health and sexual dysfunction. This partnership will enable us to further expand our product pipeline and leverage our sales force. We are enthusiastic about PSD502, which may provide a potential PE treatment, addressing an unmet medical need for millions of men.”
Steven Powell, Chief Executive Officer of Plethora, said, “We are delighted to have Sciele as a licensing partner and welcome them as a shareholder. We look forward to working with Sciele and to updating our shareholders on progress with licensing PSD502 for premature ejaculation elsewhere in territories outside the USA.”
About Plethora Solutions:
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynecological pain and premature ejaculation. In January 2006, Plethora acquired Minneapolis (MN) based Timm Medical Technologies, Inc. which markets the ErecAid® and Rigiscan® products for the treatment of erectile dysfunction (ED) to urology clinics through a US-based specialty sales team. Most recently, the ErecAid has been found to be effective for men that fail Medical Management and for men recovering from prostatectomy. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE). Further information is available at www.plethorasolutions.co.uk.
About Sciele Pharma, Inc.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes and Women’s Health. The Company’s Cardiovascular/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 and well-being of women and mothers and their babies. Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 800 people. The Company’s success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations. With respect to such forward-looking statements, we seek the protections afforded by the Private Securities Litigation Reform Act of 1995. These risks include, without limitation:
We may not attain expected revenues and earnings. If we are unsuccessful in obtaining third party payor contracts for our products, we may experience reductions in sales levels and may fail to reach anticipated sales levels. If demand for our products exceeds our initial expectations or the ability of our suppliers to provide demand-meeting quantities of product and samples, our ability to sell these products could be adversely impacted. The potential growth rate for our promoted products may be limited by slower growth for the class of drugs to which our promoted products belong and unfavorable clinical studies about such class of drugs. We may encounter problems in the manufacture or supply of our products, for which we depend entirely 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 our competitive position for our promoted products from infringers.
Altoprev has experienced manufacturing issues; if the issues recur and cannot be resolved, our ability to acquire the product for sale and sampling will be adversely affected. Sales of our Robinul product have been adversely affected by the 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 products from third parties, our financial results could be adversely impacted. We may be unable to develop or market line extensions for our products including Sular, Triglide, Fortamet, and our Prenate Line or, even if developed, obtain patent protection for our line extensions. Further, introductions by us of line extensions of our existing products may require us to make unexpected changes in our estimates for future product returns and reserves for obsolete inventory. If these risks occur, our operating results would be adversely affected. Our licensor/supplier can terminate our rights to commercialize Nitrolingual and the 60 dose size of this product has not yet met our expectation. Our new Sular formulation is presently undergoing clinical trial testing. There can be no assurance that the trial results will be positive, and if they are not, we may not be able to market and sell our new Sular formulation.
We depend on a small senior management group, the departure of any member of which would likely adversely affect our business. An adverse interpretation or ruling by one of the taxing jurisdictions in which we operate could adversely impact our operating results. A small number of customers account for a large portion of our sales and the loss of one of them, or changes in their purchasing patterns, could result in substantially reduced sales and adversely impact our financial results. If third-party payors do not adequately reimburse patients for our products, doctors may not prescribe them. Further, our business is subject to increasing government price controls and other healthcare cost-containment measures. Side effects or marketing or manufacturing problems with our products could result in product liability claims which could be costly to defend and could result in the withdrawal or recall of products from the market.
We rely on operational data obtained from IMS, an industry accepted data source. IMS data may not accurately reflect actual prescriptions (for instance, we believe IMS data does not capture all product prescriptions from some non-retail channels). An adverse judgment in the securities class action litigation in which we and certain current and former directors and executive officers are defendants could have a material adverse effect on our results of operations 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 expended significant resources for no return. Our business and products are highly regulated. The regulatory status of some of our products makes these products subject to increased competition and other risks, and we run the risk that we, or third parties on whom we rely, could violate the governing regulations; if generic competitors that compete with any of our products are introduced, our revenues may be adversely affected.
Some unforeseen difficulties may occur.
The above are some of the principal factors that could cause actual results to differ materially from those described in the forward-looking statements included above. These factors are not intended to represent a complete list of all risks and uncertainties inherent in our business, and should be read in conjunction with the more detailed cautionary statements and risk factors included in our other filings with the Securities and Exchange Commission.
Contact: Sciele Pharma, Inc. Joseph T. Schepers, 678-341-1401 ir@sciele.com or Plethora Solutions Steven Powell, 020 7269 8630 or City/Financial Enquiries - Plethora Maitland Brian Hudspith/Liz Morley, 020 7379 5151 or Scientific/Trade Press Enquiries - Plethora DeFacto Communications Richard Anderson, 020 7861 3838
Source: Sciele Pharma, Inc. and Plethora Solutions
