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Addrenex Pharmaceuticals Reaches Milestone with Filing of NDA for First Product, CloniBID, to Treat Hypertension
Date:2/20/2008

RESEARCH TRIANGLE PARK, N.C., Feb. 20 /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 regul
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