Sciele Pharma Announces That Addrenex Has Completed Enrollment Of Pivotal Phase III Trial For Clonicel For ADHD

Main Category: ADHD
Also Included In: Clinical Trials / Drug Trials
Article Date: 05 Jun 2008 - 2:00 PST

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Sciele Pharma, Inc. (NASDAQ: SCRX), a specialty pharmaceutical company, announced that Addrenex Pharmaceuticals has completed patient enrollment of its first Phase III clinical trial in the U.S. for Clonicel to treat attention deficit and hyperactivity disorder (ADHD) in children. Addrenex is also continuing to enroll patients in an additional Phase III trial using Clonicel in combination with stimulants such as methylphenidate and dextro-amphetamine/amphetamine to treat ADHD.

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.

Ed Schutter, President and Chief Operating Officer of Sciele, said, "We are pleased to announce that Addrenex has completed 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 seven products in our development pipeline: three are under review at the U.S. Food and Drug Administration (FDA) and four are in Phase III clinical trials."

Moise Khayrallah, Chief Executive Officer of Addrenex, said, "We are very pleased with the rapid progress we have made in testing Clonicel's potential ability to alleviate debilitating symptoms associated with ADHD, such as hyperactivity, impulsivity and aggression. Our goal is to provide another option for patients who need an alternative to stimulants or who may benefit from combination therapy using Clonicel together with other approved ADHD medications."

About Sciele Pharma, Inc.

Sciele Pharma, Inc. 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 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, Execution Excellence, 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.

Sciele Pharma, Inc.