Sciele Pharma And Addrenex Announce Initiation Of Pivotal Phase III Trials For Clonicel For ADHD

Main Category: ADHD
Also Included In: Clinical Trials / Drug Trials;  Hypertension
Article Date: 02 Nov 2007 - 2:00 PDT

email to a friend   printer friendly   view / write opinions

Sciele Pharma, Inc. (NASDAQ:SCRX), a specialty pharmaceutical company, and Addrenex Pharmaceuticals, today announced the initiation of patient enrollment for Phase III clinical trials in the U.S. for Clonicel to treat attention deficit and hyperactivity disorder (ADHD) in children. In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market a sustained-release formulation of clonidine hydrochloride for the treatment of ADHD and hypertension.

Patrick Fourteau, President and Chief Executive Officer of Sciele Pharma, said, "We are pleased that Addrenex has initiated patient enrollment for the Phase III trial using Clonicel to treat ADHD. Clonicel is an excellent strategic fit for our Pediatric product portfolio. Sciele has significantly expanded its product pipeline during the past year, and we now have five products in Phase III clinical trials. Two other products are currently under review at the FDA."

Moise Khayrallah, Chief Executive Officer of Addrenex, commented, "We are excited about the benefits Clonicel may provide children between the ages of 6 and 17 who have ADHD. This is the first Phase III clinical trial that is being conducted using a new formulation of clonidine for the treatment of ADHD. Clonicel is a 12-hour, sustained-release formulation, which is designed to reduce the side effects of clonidine."

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Metabolic, Women's Health and Pediatrics. The Company's Cardiovascular/Metabolic 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 900 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.

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® 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.

http://www.sciele.com