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Clonicel

Treatment for Attention Deficit Disorder

sNDA Submitted to FDA for Clonicel

Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD

ATLANTA--(BUSINESS WIRE)--Oct 1, 2009 - Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD). In multi-center, placebo-controlled, double-blind, randomized Phase III clinical trials, Clonicel showed statistical significance when used to treat ADHD.

Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, "We are pleased that Addrenex has filed the sNDA with the FDA. Clonicel is an important product in our pediatric pipeline, and we are excited about the potential benefit that Clonicel may provide to children and adolescents who have ADHD."

Moise Khayrallah, PhD, Chief Executive Officer of Addrenex Pharmaceuticals, said, "Clonicel was designed to normalize excess adrenergic hormones that may cause symptoms of ADHD. In phase III clinical trials, Clonicel demonstrated an improvement in an aggregate of 18 ADHD symptoms recognized by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents."

In July 2007, Sciele signed an exclusive licensing agreement with Addrenex to market its modified-release formulation of clonidine hydrochloride for the treatment of ADHD and hypertension in the United States, Mexico and Canada.

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 approximately 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. For more information on Sciele, please visit www.sciele.com.

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 Addrenex Pharmaceuticals Inc

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex is based in Durham, N.C., on the edge of Research Triangle Park. The company's mission is to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, pain, and post-menopausal symptoms. Currently, Addrenex has three products in clinical trials and a library of over 400 compounds available for future development. For more information, visit www.addrenex.com.

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, 678-341-1401

ir@sciele.com

 

 

Posted: October 2009

Clonicel (clonidine) FDA Approval History

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