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Tuesday, November 6, 2007

Sciele Pharma and Addrenex announce initiation of Pivotal Phase III Trials for Clonicel for ADHD

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."

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