Public Release:  Pivotal study for PSD502 -- the first potential treatment for premature ejaculation

On-demand aerosol spray increased ejaculatory latency

HealthStar PR

ATLANTA / SAN DIEGO (November 19, 2009) - At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE). Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo. Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.

An estimated one-third of U.S. men ages 18 - 59 are affected by PE, making it twice as prevalent as erectile dysfunction. Currently, there are no prescription therapies approved in the U.S. to treat PE.

PSD502, a product in development for the treatment of PE, is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed by a metered dose aerosol. PSD502 works selectively on non-keratinized skin on the glans penis (head of the penis).

"Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners," said Professor Stanley E. Althof, PhD, Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida. "Recently, the international sexual health community agreed that PE should be defined as ejaculation occurring within approximately one minute of penetration that causes the patient distress. Now we need to work to develop treatments, and these encouraging results with PSD502 seem to be a step in the right direction."

Both pivotal trials showed clinically and statistically significant efficacy in the treatment of premature ejaculation, as measured by changes in Intravaginal Ejaculatory Latency Time (IELT) and Index of Premature Ejaculation (IPE), a patient-reported outcome of ejaculatory control, sexual satisfaction, and distress.

"We are excited that results from two pivotal studies have shown that PSD502 was effective for men with PE, and we look forward to the opportunity to help patients who have had no real options to date," said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc. "This data will support the New Drug Application for PSD502 that we are planning to submit to the U.S. Food & Drug Administration (FDA), which upon FDA approval would make PSD502 be the first prescription treatment in the U.S. for premature ejaculation."

Pivotal Study Details

The new study, the second of two major pivotal trials, was designed to assess the clinical benefit and safety of PSD502 in men with PE. The trial, which randomized 256 patients across 38 investigational centers in the U.S., Canada and Poland, also assessed the safety and tolerability of the therapy. Final analyses of the three months data confirmed that PSD502 produced a clinically and statistically significant increase from baseline in all study primary and secondary endpoints. The time for IELT for PSD502 group increased 4.7-fold compared to 1.5-fold in placebo (p< 0.0001), resulting in a geometric mean IELT of 2.6 minutes in the PSD502 group and 0.8 minutes in the placebo group.

There were improvements in IPE scores in the PSD502 group, which recorded patient and partner feedback, compared to placebo, resulting in 5.0-, 4.6- and 2.5-point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains, respectively (p<0.0001 between treatment comparisons).

Overall, PSD502 was well-tolerated, with no serious adverse events reported by patients or partners in the studies.

Also presented for the first time at SMSNA were two subset analyses of the European Phase III trial data showing:

  • Increased ejaculatory latency and improvements in patent-reported outcomes seen in the first month of use with PSD502 were maintained over two to three months of treatment; and
  • A significant positive correlation between mean IELT and IPE domain scores after three months of treatment, indicating that increases in IELT are associated with improvements in patient-reported outcomes.

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About Premature Ejaculation

For years, various experts debated on the true definition of premature ejaculation. In 2008, the International Society for Sexual Medicine presented an evidence-based definition of PE as agreed upon by a consensus of the world's leading sexual health experts: a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. For additional information on PE visit http://socialpress.sciele.com/

About Sciele Pharma, Inc.

Sciele Pharma, Inc., an indirect wholly-owned subsidiary of Shionogi & Co., Ltd, 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, head lice, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs approximately 1000 people. The Company's success is based on placing the needs of patients first and improving health and quality of life.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of people who need them. In addition, Shionogi is engaged in some new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp.

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. 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.

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:
Joseph T. Schepers
Sciele Pharma, Inc.
404-388-6182
JSchepers@sciele.com

Dave Schemelia
HealthStar Public Relations
609-468-9325
DSchemelia@healthstarpr.com

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