| News Release View printer-friendly version | | << Back | | Sciele Pharma Acquires Global Rights For PSD502 From Plethora Solutions | ATLANTA (May 26, 2009) – Sciele Pharma, Inc., a Shionogi Company, today announced that it has acquired the global rights for PSD502 from Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC (“Plethora” – AIM:PLE). Under the terms of the agreement, Sciele has made payments totaling $8.4 million to Plethora, its debt holders, and the inventor of the product. Sciele will also share development costs for PSD502 for non-US territories and pay Plethora a royalty on non-US revenues.
In April 2009, Plethora and Sciele amended the 2007 US license agreement for PSD502, and as a result, Sciele owns the New Drug Application as well as all US rights to the product.
Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, “We are pleased to extend our commitment to PSD502 beyond the US market, and we expect to file for regulatory approval in Europe and the US in the first half of 2010. We will look at various options to commercialize PSD502 in Europe and other geographic 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 reported to affect between 25% and 30% of men in Europe and the USA.
Data from the European Phase III Study reported in November 2008 showed that PSD502 demonstrated statistically significant increases from baseline in all three co-primary study endpoints and secondary endpoints. The primary endpoints in the European study are Intra-vaginal Ejaculation Latency Time (IELT), sexual satisfaction and ejaculatory control. Secondary endpoints include sexual quality of life and partner satisfaction. Patient recruitment to the Phase III program in the United States has been completed. Results of the Phase III Clinical Studies are expected in the second half of 2009.
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, 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.
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, 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.
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
Director, Corporate Communications
Sciele Pharma, Inc.
Phone: 678-341-1401
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