sNDA for Clonicel submitted to the FDA

Oct 2 2009

Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company 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). The submission is based on the successful completion of Phase III clinical trials demonstrating statistical significance when Clonicel was used to treat ADHD in children and adolescents.

“The sNDA filing for Clonicel is an important milestone for physicians and the millions of patients and their families seeking a non-stimulant alternative for the treatment of ADHD,” said Moise Khayrallah, PhD, Chief Executive Officer of Addrenex Pharmaceuticals. “For Addrenex, this filing is another exciting accomplishment in our company’s brief history, further validating our drug development model in bringing new drugs to market to fill unmet needs.”

Clonicel is the company’s lead compound in a pipeline of products targeting conditions arising from an overactive adrenergic system, the body’s control center for regulating stress and a host of other physiologic functions. In less than three years since the specialty pharmaceutical company’s founding, Durham-based Addrenex has developed a promising portfolio of four products in clinical trials and over 400 compounds available for future development to treat hypertension, ADHD, narcolepsy, procedural sedation, insomnia, menopausal flushing and dermatologic indications.

The North American rights to market Clonicel are licensed to Atlanta based specialty pharmaceutical company Sciele Pharma. 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.”

http://www.addrenex.com/