Sciele Pharma And Plethora Solutions Holdings PLC Announce Initiation Of Pivotal Phase III Trials For PSD502 For Premature Ejaculation

Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Clinical Trials / Drug Trials;  Men's health;  Urology / Nephrology
Article Date: 02 Nov 2007 - 4:00 PDT

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Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, and Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, jointly announced that they have initiated patient enrollment for the Phase III clinical trials in the U.S. for PSD502 for the treatment of premature ejaculation. In May 2007, Sciele signed an exclusive licensing agreement for PSD502 with Plethora Solutions.

PSD502 is a proprietary formulation of two marketed drugs - lidocaine and prilocaine - dispensed by a metered dose aerosol and developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the U.S. and for which there currently is no FDA-approved prescription treatment. The product is applied locally when needed (often referred to as "on demand" therapy) and is effective within five minutes. The product has been shown to increase ejaculation latency time substantially when compared with placebo in a multi-center Phase II study. This data was published recently in BJU International (Dinsmore W et al 2007, BJU Int 99: 369-35).

Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma, said, "We are pleased with the excellent progress Plethora has made with the development of PSD502, initiating the Phase III pivotal trials within our previously announced timelines. PSD502 for premature ejaculation addresses an unmet medical need that affects a significant number of adult males in all age groups."

Steven Powell, Chief Executive Officer of Plethora, commented, "We are pleased to be advancing PSD502 into the final stage of clinical development for the treatment of premature ejaculation. If patient recruitment proceeds as planned, we would expect to see headline data towards the end of 2008 which will be a major milestone in the life of both this product and Plethora."

Study Details:

Plethora intends to run the two pivotal studies in parallel, one in the U.S. and one in Europe. Each will be a multi-center, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. Patients will be treated for a 12-week period with an optional five-month open-label phase. The primary endpoints will be Intra-vaginal Ejaculation Latency Time (IVELT), sexual satisfaction and ejaculatory control. Secondary endpoints will include Sexual Quality of Life and partner satisfaction. The study design and powering, in agreement with both U.S. and E.U. regulatory authorities, employ validated patient reported outcomes (PROs). The two studies will recruit patients in 36 centers in Europe and 38 in the U.S. and Canada, including almost all North American opinion leaders. It also has been agreed with the regulators that one-year open-label extensions to the studies are not required, which will reduce time to study closure considerably.

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 http://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/Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic 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/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 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.

http://www.sciele.com