Premature Ejaculation - Plethora Solutions Has Completed European Phase III Trial Of PSD502

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Urology / Nephrology;  Men's health;  Clinical Trials / Drug Trials
Article Date: 01 Oct 2008 - 9:00 PDT

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Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, today announced that Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

In recently published results from a Phase II study, PSD502 was shown to increase ejaculation latency time significantly when compared with placebo (Dinsmore W et al BJU Int 2007; 99: 369-35).

There are two pivotal PSD502 studies running in parallel, one in North America and one in Europe. Each is a multi-centre, randomized, double blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. 275 patients will have completed the blinded phase of the study across 32 investigational centers in 4 countries across Europe. Of these, 265 patients have entered an optional 5 month open-label study.

Recruitment in the equivalent study in the U.S. is ongoing and data from the two studies will be combined for submission for regulatory approval in the U.S. and Europe. A new drug application (NDA) for PSD502 is expected to be submitted to the FDA in the first half of 2009.

In May 2007, Sciele signed an exclusive licensing agreement with Plethora Solutions to market PSD502 in the U.S.

Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, "We are pleased with the progress Plethora has made with the development of PSD502, which addresses an unmet medical need that affects a significant number of adult males in all age groups."

Dr. Mike Wyllie, CSO of Plethora, commented, "We are delighted to have completed this arm of the Phase III study. The willingness of patients to enter the open-label study is most encouraging as is the low dropout rate throughout the trial. The speed at which recruitment was completed, given the stringent entry criteria, confirms both the number of PE patients in the general population and their willingness to seek treatment."

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs more than 1000 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, Execution Excellence, Simplicity, and Teamwork. http://www.sciele.com

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, erectile dysfunction and premature ejaculation. Plethora has a US subsidiary, Timm Medical Technologies Inc, which markets products for the treatment of erectile dysfunction (ED) to urology clinics through a national US specialty sales team. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE). Further information is available at http://www.plethorasolutions.co.uk.

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.