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 the final analysis of its European Phase III double-blind placebo-controlled study of PSD502 for the treatment of premature ejaculation ('PE'). PSD502 has met not only its three co-primary endpoints of Intravaginal Ejaculation Latency Time ('IELT') and Index of Premature Ejaculation ('IPE'; Ejaculatory Control and Sexual Satisfaction domains), but also all secondary endpoints.

The successful European study is one of two pivotal Phase III studies conducted in parallel with identical protocols. The second Phase III study is expected to be completed in the first half of 2009. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.

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, 268 patients have now been entered into the optional nine-month open-label study.

European Phase III Study Outcome

Final analyses confirmed not only that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints, but also in all secondary endpoints. The IELT 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 Ejaculatory Control (p<0.0001) and a six-point difference between PSD502 and placebo in Sexual Satisfaction (p<0.0001), where a two-point difference in a 16-point range is considered clinically significant. There was a three-point difference between PSD502 and placebo in the IPE domain for distress (p<0.0001).

Of patients who received PSD502, 91% achieved an IELT of greater than one minute and 75% achieved an IELT of greater than two minutes following treatment. This compared with only 54% and 22% of placebo patients, respectively. Both endpoints were highly clinically and statistically significant (p<0.0001).

There was a highly statistically significant (p<0.0001) improvement in scores for all four secondary endpoints; that is Control, Distress, Satisfaction and Interpersonal Difficulty in the PSD502 group, compared with placebo. Importantly, both patients and partners benefited from the treatment.

The number of patients in the PSD502 group who rated the quality of their orgasm as good or very good increased from 20% at baseline to 62% after treatment. In comparison, the number of placebo-treated patients with this rating decreased from 21% to 19%.

The study treatment was rated positively by 86% of patients who received PSD502 compared with 34% of placebo patients.

The Principal Investigator in the study, Prof. Wallace Dinsmore, Royal Victoria Hospital, Belfast, commented: "These results are as impressive as those observed with the phosphodiesterase inhibitors (PDEi) in erectile dysfunction at an equivalent stage of development. The positive impact of PSD502 on both patients and their partners could benefit many relationships."

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. Of these adverse events, only one patient who received PSD502 (0.5%) reported temporary numbness of the penis, which was described as mild. PSD502 was well tolerated and there were no systemic adverse events.

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 reported to affect between 25% and 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation.

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.

Dr. Mike Wyllie, CSO of Plethora, said, "The new data confirm and extend our initial highly encouraging analyses. We now await the final results from the US study in the first half of 2009. These highly significant results have expedited our licensing discussions for territories 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 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 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 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.