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Sciele Pharma Announces That Addrenex Pharmaceuticals Initiates Phase II Clinical Trial of ADX415 for the Treatment of Hypertension

Posted on: Thursday, 23 October 2008, 09:00 CDT

Sciele Pharma, Inc., a Shionogi Company, today announced that Addrenex Pharmaceuticals, Inc. has initiated its Phase II clinical trial with ADX415 for the treatment of hypertension. This is a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study that will involve 80 patients. ADX415 is a novel, patented, centrally acting, alpha-adrenergic receptor agonist, specific to Alpha-2 receptors.

Larry Dillaha, Chief Medical Officer of Sciele Pharma, said, "We are pleased with the progress by Addrenex in developing ADX415, which is being studied in patients for the treatment of hypertension."

Moise Khayrallah, Chief Executive Officer of Addrenex, said, "While the adrenergic system is best known for its role in triggering the 'fight or flight' response, it is actually a wide-ranging and varied regulator of multiple processes in the body, including blood pressure. We are truly excited about the potential of ADX415, an adrenergic regulator that is designed to target specifically the alpha-2 receptor pathway. We believe this therapeutic area may have a meaningful impact on patients' health and wellbeing."

On July 1, 2008, Sciele announced an exclusive agreement with Addrenex Pharmaceuticals to develop and market ADX415. Under the terms of the agreement, Sciele has the worldwide marketing rights for ADX415.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., a subsidiary of Shionogi & Co. Ltd., is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/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/hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma 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, Speed of Execution, 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.

About Addrenex

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Durham, North Carolina, on the edge of Research Triangle Park. The company was formed in 2006 by a practicing physician and a drug development expert with the mission to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Addrenex identified adrenergic regulation as its initial research focus. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will use the knowledge and experience gained from developing CLONICEL(R) as the foundation for additional discovery and development in the area of adrenergic regulation.

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.

Source: Business Wire

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