Sciele Pharma and Plethora Solutions Announce Positive Results of Final Phase III Pivotal Trial for PSD502 for Premature Ejaculation

ATLANTA--(BUSINESS WIRE)--Jul 29, 2009 - Sciele Pharma Inc.:


 

 


 


  • Statistically and Clinically Significant Increase in all 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), today announced that a second and final Phase III double-blind, placebo-controlled study of PSD502 for the treatment of premature ejaculation (˜PE') has met all co-primary endpoints of Intra-vaginal Ejaculation Latency Time (˜IELT'), Index of Premature Ejaculation (˜IPE,' Ejaculatory Control, Sexual Satisfaction and Distress domains).


 

This successful study, involving patients from the USA, Canada and Europe, is one of two pivotal Phase III studies that were run in parallel with identical protocols. The previously announced Phase III study was conducted entirely in Europe, and its successful outcome was reported in November 2008. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.


 

Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, “We are pleased with these initial Phase III efficacy results in this final Study for PSD502, which, upon FDA approval, would be the first prescription treatment in the United States for premature ejaculation.”


 

Phase III Study Details:


 

Each Phase III study was a multi-centre, randomised, double blind, placebo-controlled efficacy study that recruited a total of 540 patients across the two studies. Patients were treated for a 12-week period with an optional open-label phase of up to nine months.


 

Outcome of Second Phase III Study:


 

Entirely consistent with the first study, analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all co-primary study endpoints. The intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with PSD502 when compared to baseline (p<0.0001). There was a five-point difference between PSD502 and placebo in the IPE domains for ejaculatory control and sexual satisfaction (p<0.0001), where a two-point difference is considered clinically significant. There was a 2.5-point difference between PSD502 and placebo in the IPE domain for Distress (p<0.0001), where a two-point difference is considered clinically significant. As a secondary endpoint, partner satisfaction was also found to be considerably greater with PSD502 than placebo.


 

The incidence of serious adverse events and overall side effects was similar in the PSD502 and placebo group. Overall, PSD502 was well tolerated and there were no systemic adverse events. As previously reported, a very low incidence of mild penile numbing (<3%) was observed.


 

Dr. Ira Sharlip, Clinical Professor of Urology at the University of California at San Francisco and Past-President of the International Society of Sexual Medicine, commented, “These are highly clinically significant results that show PSD502 is likely to be of considerable benefit to both patient and partner. Particularly pleasing is the ability to take the product on demand. The rapid onset of action of just five minutes is one of its most attractive characteristics. I believe that PSD502 will be a very valuable addition to our armamentarium for the treatment of premature ejaculation.”


 

Dr. Mike Wyllie, Chief Scientific Officer of Plethora, said, “Although not unexpected, we are delighted with these highly significant results from the second and final Phase III clinical study, which represents an important milestone in the regulatory submission process.”


 

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 the USA and Europe.


 

In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc., (˜Sciele'), to market PSD502 for premature ejaculation in the USA. In May 2009 Sciele acquired global rights to the product.


 

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. For more information please, visit www.sciele.com.


 

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., 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 (PSD506), stress urinary incontinence (PSD503), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). 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: Sciele Pharma, Inc.

Joseph T. Schepers, Director, Corporate Communications, 678-341-1401

Cell: 404-388-6182

JSchepers@sciele.com


 

 

Posted: July 2009

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