1 Apr 2009 07:00
| For Immediate Release | 1st April 2009 |
PLETHORA SOLUTIONS HOLDINGS PLC
Amendment to US License Agreement for PSD502 for Premature Ejaculation
Plethora Solutions Holdings PLC ("Plethora", "The Company", AIM : PLE), the specialist developer of products for the treatment and management of urological disorders, announced today that, following a recent meeting with the FDA regarding PSD502 for the treatment of premature ejaculation, it has amended its US License Agreement for PSD502 with Sciele Pharma, Inc. ("Sciele"); a Shionogi company. Under the terms of this amendment, Sciele has made additional license payments totalling $13.7m to Plethora and its debt providers, with the Company retaining $7m. Sciele will now assume all future development and regulatory costs related to PSD502 in the USA and will own the New Drug Application for the US market. Plethora will not receive any further payments and royalties from Sciele with respect to US rights. To date, including these most recent license payments, Plethora has received more than $21.5m from Sciele via license payments, share purchase and development contributions for the US rights to PSD502 since the original licensing agreement was signed in May 2007.
In February 2009, in advance of the amendment to the license, Sciele provided Plethora with a loan of £1.3m to fund ongoing development of PSD502. This money has been repaid out of the $7m payment to Plethora.
About PSD502:
PSD502 is a patient-friendly 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.
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For further information contact:
| Plethora Solutions Steven Powell | Tel : 020 3077 5406 |
| FinnCap Geoff Nash | Tel: 020 7600 1658 |
| Hansard Group Adam Reynolds/John Bick | Tel: 020 7245 1100 |
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:PLE.L). Further information is available at 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 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 Corporate Communications
678-341-1401
ir@sciele.com