Friday, July 13, 2007

Sciele Pharma Signs Agreement with Addrenex Pharmaceuticals to Market CLONICEL

Sciele PharmaSciele Pharma, Inc. (NASDAQ: SCRX) today announced that it has signed an exclusive agreement with Addrenex Pharmaceuticals, Inc. to market, upon approval by the U.S. Food & Drug Administration (FDA), CLONICEL(R), a patented, sustained-release formulation of clonidine hydrochloride for the treatment of hypertension and attention deficit and hyperactivity disorder in North America. Sciele will also have the right of first refusal for other Addrenex products focused on pediatrics, women's health, and cardiovascular/metabolic diseases. Under the terms of the agreement, Sciele has purchased a $6 million equity stake in Addrenex and will have the right to increase its equity stake in Addrenex by an additional 10%. Sciele will also make regulatory milestone payments of up to $11 million and royalty payments to Addrenex on product sales.

Clonidine hydrochloride is an alpha-2 agonist approved for the treatment of hypertension. During the past year, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data. CLONICEL(R) is a 12-hour, sustained-release formulation of clonidine hydrochloride, which currently is in pivotal clinical trials for hypertension. A 505(b)(2) NDA filing with the FDA is expected in the second half of 2007. A Phase III clinical trial utilizing CLONICEL(R) for ADHD is expected to begin in the second half of 2007.

Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "This agreement with Addrenex provides us with the opportunity to further expand both our cardiovascular and pediatric product lines. We continue to execute on our strategy to diversify our product portfolio and expand our late-stage product pipeline through the licensing and acquisition of products."

Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex, said, "We are very happy that a successful company such as Sciele sees the potential of our lead compound CLONICEL(R). We look forward to a rewarding partnership that will allow Addrenex to develop and commercialize this product as well as future compounds in our adrenergic regulation portfolio."

About Sciele Pharma, Inc.

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

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Morrisville, 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(R) as the foundation for additional discovery and development in the area of adrenergic regulation.

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