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CloniBID

Generic name: clonidine hydrochloride
Treatment for: High Blood Pressure

Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension

RESEARCH TRIANGLE PARK, N.C., February 20, 2008 /PRNewswire/ -- Addrenex Pharmaceuticals has reached its first milestone accomplishment this year with the filing of a new drug application (NDA) for its first drug, CloniBID, to treat hypertension. Upon approval from the Food and Drug Administration, Addrenex and its licensing partner Sciele Pharma, Inc. will launch the drug in the first half of 2009.

Addrenex has moved swiftly to develop and commercialize CloniBID, a sustained-release formulation of clonidine hydrochloride. The company recently entered its second year of operation and already has developed and tested its two lead products, CloniBID for hypertension and Clonicel for the treatment of attention deficit hyperactivity disorder (ADHD). Clonicel is currently undergoing phase 3 clinical trials nationwide and will complete the trials by the end of the year.

Both drugs are designed to circumvent the bothersome side effects of generic clonidine, including a peak of sedation when the drug is absorbed and a subsequent rebound of hypertension once the drug's effects wear off. Such unwanted "peaks and troughs" have limited the drug's use in some patients who otherwise have responded very well to the drug's beneficial effects, said Moise Khayrallah, cofounder and CEO of Addrenex.

Last year, Addrenex quickly acquired the necessary data to attract Sciele's interest in licensing the rights to market both drugs. Sciele purchased a $6 million equity stake in Addrenex, with the potential for an additional $11 million in milestone payments. Sciele also holds the first right of refusal to market Addrenex's future products in the areas of pediatrics, women's health, cardiovascular and metabolic diseases.

The agreement with Sciele in June was followed by a second contract in December, granting Addrenex the rights to a vast library of nearly 400 compounds at the University of Nebraska Medical Center. The library of compounds focuses on adrenergic regulation, the basis of Addrenex's drug development efforts.

"We credit our rapid success in developing viable drugs and building partnerships to our nimble, fast-paced business model and outside-the-box thinking," Khayrallah said. "We stay sharply focused on the major milestones that must be accomplished, and we don't allow perceived impediments to hamper our progress."

Addrenex's goal is to develop a diverse pipeline of products aimed at regulating the adrenergic system, a vast and varied regulator of multiple bodily processes. The alpha-2 adrenergic receptors in particular have been implicated in a wide variety of medical conditions, including hypertension, ADHD, menopausal flushing, migraine, sleep disturbances, aggression, pain and addiction.

Few drugs on the market are known to target the alpha-2 adrenergic receptors; hence, Addrenex is seeking to fill a void in this pharmaceutical niche, Khayrallah said.

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 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 CloniBID and Clonicel as the foundation for additional discovery and development in the area of adrenergic regulation.

CONTACT: Becky Levine for Addrenex Pharmaceuticals, +1-919-786-4918 x137, blevine@medthink.com

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Posted: February 2008

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