Sciele Pharma, Inc. Announce Completion Of Patient Recruitment For Global Phase III Trial Of PSD502 For Premature Ejaculation

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 20 Feb 2009 - 0:00 PDT

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Sciele Pharma, Inc., a Shionogi company, and Plethora Solutions Holdings PLC ("Plethora," AIM: PLE), today announced the completion of patient recruitment of the PSD502 registration program for the treatment of premature ejaculation (PE). The preliminary results from this North American study are expected in mid-year 2009. A parallel European Phase III study of PSD502 concluded successfully in November 2008 with a positive outcome that was both clinically and statistically significant.

Each of these two pivotal studies is a multi-center, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. The conclusion of the North American program represents the culmination of the global phase III program for PSD502.

North American Study Details

Recruitment of the global Phase III program has now closed. All patients have entered a four-week screening and baseline period, with at least 240 patients expected to be randomized shortly to a 12-week, double-blind treatment period followed by an optional open-label phase. The primary endpoints, as in the European study, are Intra-vaginal Ejaculation Latency Time (IELT), sexual satisfaction and ejaculatory control. Secondary endpoints include sexual quality of life and partner satisfaction.

European Phase III Study Outcome

Data from the European Phase III reported in November 2008 showed that PSD502 produced both clinically and statistically significant increases from baseline in all three co-primary study endpoints and secondary endpoints. There were no serious adverse events, the drug was well tolerated and there were no systemic adverse events.

Dr. Mike Wyllie, CSO of Plethora, commented, "This represents a major milestone in the clinical development program of PSD502, and we expect to report on the outcome later in the year. At that time, filings for global product registration are expected to be completed."

About PSD502

PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation in the United States.

In May 2007, Plethora signed an exclusive license agreement with Sciele to market PSD502 for premature ejaculation in the USA, which was amended in February 2009 subject to a satisfactory outcome of an FDA meeting scheduled for March 2009.

About Plethora

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, gynaecological 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:LSE). Further information is available at http://www.plethorasolutions.co.uk.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., a Shionogi Company, 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 1,000 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.

On October 9, 2008, Shionogi & Co., Ltd. and Sciele Pharma announced the completion of Shionogi's acquisition of Sciele. Sciele is now an indirect wholly owned subsidiary of Shionogi.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd. is a major research-driven Japanese pharmaceutical manufacturer. The company's primary businesses are research and development, manufacturing, marketing, and import and export sales of pharmaceuticals and diagnostics. Shionogi follows a basic policy of continually providing the superior medicines essential to people's health. For more details, please visit http://www.shionogi.co.jp.

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.

Shionogi & Co., Ltd