Sciele Pharma, Inc. and Plethora Solutions Holdings Announce Positive Phase III Clinical Results of PSD502 for Premature Ejaculation; Statistically And Clinically Significant Increase In All Three Co-Primary Endpoints
Well tolerated and devoid of systemic side effects
Sciele Pharma, Inc., a Shionogi Company, and Plethora Solutions Holdings PLC ("Plethora"-AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, today announced that the European Phase III double-blind placebo-controlled study of PSD502 for the treatment of premature ejaculation ('PE') has met its three co-primary endpoints of Intravaginal Ejaculation Latency Time ('IELT') and Index of Premature Ejaculation ('IPE'; Ejaculatory Control and Sexual Satisfaction domains).
The successful European study is one of two pivotal Phase III studies running in parallel with identical protocols. The second Phase III study is being conducted in North America and is expected to be complete in the first quarter of 2009. Once the results from the US Phase III study become available, data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
European and US Phase III Study Details:
Each Phase III study is a multicenter, randomized, double-blind, placebo-controlled efficacy study, and the program is expected to recruit a total of 540 patients across the two studies. Patients are treated for a 12-week period with an optional open-label phase of up to nine months.
The European study was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 265 patients also entered the optional nine-month open-label study.
European Phase III Study Outcome:
Initial analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The IELT geometric mean for PSD502 was four minutes compared with one minute in placebo (p<0.0001). There was a seven-point difference between PSD502 and placebo in the IPE domain for Ejaculatory Control (p<0.0001) and a six-point difference between PSD502 and Placebo in the IPE domain for Sexual Satisfaction (p<0.0001), where a two-point difference in a 16-point range is considered clinically significant.
There were no serious adverse events, and only 2.6% of patients reported treatment-related adverse events in the PSD502 group compared with 1% in the placebo group. PSD502 was well tolerated and there were no systemic adverse events.
Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, "We are pleased with the phase III results of PSD502, which addresses an unmet medical need that affects a significant number of adult males in all age groups. Upon FDA approval, this would be the first prescription medication available for men with PE."
Dr. Mike Wyllie, CSO of Plethora, said, "We are clearly delighted with these highly significant results from the European Phase III clinical study and now await the final results from the US study in the first half of 2009. We already have a partner for the US market and will now move ahead with our discussions with prospective partners across other territories."
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 between 25% and 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation. PSD502 is applied locally "on demand" and is effective within five minutes. PSD502 has a good safety profile with minimal partner transfer.
In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc. to market PSD502 for premature ejaculation in the USA while retaining the option to co-promote the product to the US urologist market. Licensing discussions are ongoing with a number of potential partners for PSD502 outside of the USA.
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 US national sales operation. 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 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.
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 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.
Contact: Sciele Pharma, Inc. Joseph T. Schepers Director of Investor Relations 678-341-1401 ir@sciele.com
Source: Sciele Pharma, Inc.