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Addrenex Pharmaceuticals Licenses New Compound to Sciele Pharma for the Treatment of Hypertension and Other Potential Indications

Wednesday, July 2, 2008 General News
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DURHAM, N.C., July 1 Two years after AddrenexPharmaceuticals set it sights on building a new class of drugs to regulate"adrenergic excess," the small Durham company has signed its second major dealwith Sciele Pharma, this time to co-develop a new compound for hypertensionand other potential indications.
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Adrenalin is well known as the hormone that triggers the "fight or flight"reaction in response stress or danger. But Addrenex scientists recognized thishormone, and its counterpart in the brain, noradrenalin, as regulators ofdiverse physiologic functions -- from blood pressure to energy expenditure tothermostatic control.
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"No other company is targeting adrenergic regulation as the root cause ofconditions," said Moise Khayrallah, CEO of Addrenex. "We built our company toaddress a wide range of conditions whose symptoms are being partially managedby drugs currently on the market, but whose origins have never beenspecifically treated."

Last year the company efficiently advanced its first products, Clonicel(R)to treat attention deficit hyperactivity disorder and CloniBID to treathypertension, into Phase 3 clinical trials. In July 2007, Addrenex licensedboth products to Sciele Pharma for $6 million in upfront equity, $11 millionin milestones, and future royalty payments on product sales.

One year later, the company has signed this second, larger deal, toinclude up to $27 million in development and regulatory milestones and futureroyalty payments on product sales. In addition, Sciele will pay alldevelopment costs.

"The partnership with Sciele is particularly rewarding because validatesour work to date and confirms that our products may fill a critical gap in thetreatment of debilitating conditions," said Khayrallah.

Addrenex began its foray into drug development by tweaking an existingdrug, clonidine, to extend its benefits and reduce bothersome side effects.Company co-founder Joseph Horacek, M.D., originated the idea while seeking abetter way to manage symptoms of aggression, hyperactivity and sleeplessnessamong his pediatric patients with ADHD.

The company quickly moved to advance its pipeline beyond traditionalalpha-2 receptor agonists to compounds that would more selectively targetspecific subtypes of the alpha-2 receptor.

Alpha-2 receptors are present throughout the brain and body. They bindwith adrenergic hormones and neurotransmitters such as adrenalin andnoradrenalin to control a wide range of physiological functions. Malfunctionsin the alpha-2 receptor pathway have been implicated in a wide range ofconditions, including hypertension, pain, addiction, post traumatic stressdisorder, menopausal symptoms, aggression and hyperactivity.

Yet few known drugs target the specific receptors involved in suchconditions, Khayrallah said.

In December, Addrenex dramatically expanded its potential pipeline ofdrugs by licensing an existing library of 400 alpha-2 adrenergic compoundsfrom UNeMed, the technology transfer arm at the University of Nebraska MedicalCenter. These compounds were originally developed by Procter & Gamble andlater gifted to the university. Scientists at the university and Addrenexhave already begun sifting through the data and examining compounds thatappear to have selective affinity for the various alpha 2 receptor subtypes.

ADX415 was selected as a lead compound because of its receptor subtypeprofile and because it had undergone extensive preclinical and early clinicalsafety testing.

http://www.addrenex.com/

SOURCE Addrenex Pharmaceuticals
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