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

Wednesday, February 20, 2008 General News
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RESEARCH TRIANGLE PARK, N.C., Feb. 20 AddrenexPharmaceuticals has reached its first milestone accomplishment this year withthe filing of a new drug application (NDA) for its first drug, CloniBID, totreat hypertension. Upon approval from the Food and Drug Administration,Addrenex and its licensing partner Sciele Pharma, Inc. will launch the drug inthe first half of 2009.

Addrenex has moved swiftly to develop and commercialize CloniBID, asustained-release formulation of clonidine hydrochloride. The company recentlyentered its second year of operation and already has developed and tested itstwo lead products, CloniBID for hypertension and Clonicel for the treatment ofattention deficit hyperactivity disorder (ADHD). Clonicel is currentlyundergoing phase 3 clinical trials nationwide and will complete the trials bythe end of the year.

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

Last year, Addrenex quickly acquired the necessary data to attractSciele's interest in licensing the rights to market both drugs. Scielepurchased a $6 million equity stake in Addrenex, with the potential for anadditional $11 million in milestone payments. Sciele also holds the firstright of refusal to market Addrenex's future products in the areas ofpediatrics, women's health, cardiovascular and metabolic diseases.

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

"We credit our rapid success in developing viable drugs and buildingpartnerships to our nimble, fast-paced business model and outside-the-boxthinking," Khayrallah said. "We stay sharply focused on the major milestonesthat must be accomplished, and we don't allow perceived impediments to hamperour progress."

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

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

About Addrenex Pharmaceuticals, Inc.

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical companythat develops and commercializes drugs to treat adrenergic dysregulation.Addrenex Pharmaceuticals is based in Durham, North Carolina, on the edge ofResearch Triangle Park. The company was formed in 2006 by a practicingphysician and a drug development expert with the mission to explore the impactthat 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 ashypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will usethe knowledge and experience gained from developing CloniBID and Clonicel asthe foundation for additional discovery and development in the area ofadrenergic regulation.

SOURCE Addrenex Pharmaceuticals

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