DURHAM, N.C., July 1 /PRNewswire/ -- Two years after Addrenex Pharmaceuticals set it sights on building a new class of drugs to regulate "adrenergic excess," the small Durham company has signed its second major deal with Sciele Pharma, this time to co-develop a new compound for hypertension and other potential indications.
Adrenalin is well known as the hormone that triggers the "fight or flight" reaction in response stress or danger. But Addrenex scientists recognized this hormone, and its counterpart in the brain, noradrenalin, as regulators of diverse physiologic functions -- from blood pressure to energy expenditure to thermostatic control.
"No other company is targeting adrenergic regulation as the root cause of conditions," said Moise Khayrallah, CEO of Addrenex. "We built our company to address a wide range of conditions whose symptoms are being partially managed by drugs currently on the market, but whose origins have never been specifically treated."
Last year the company efficiently advanced its first products, Clonicel(R) to treat attention deficit hyperactivity disorder and CloniBID to treat hypertension, into Phase 3 clinical trials. In July 2007, Addrenex licensed both products to Sciele Pharma for $6 million in upfront equity, $11 million in milestones, and future royalty payments on product sales.
One year later, the company has signed this second, larger deal, to include up to $27 million in development and regulatory milestones and future royalty payments on product sales. In addition, Sciele will pay all development costs.
"The partnership with Sciele is particularly rewarding because validates our work to date and confirms that our products may fill a critical gap in the treatment of debilitating conditions," said Khayrallah.
Addrenex began its foray into drug development by tweaking an existing drug, clonidine, to extend its benefits and reduce bothersome side effects. Company co-founder Joseph Horacek, M.D., originated the idea while seeking a better way to manage symptoms of aggression, hyperactivity and sleeplessness among his pediatric patients with ADHD.
The company quickly moved to advance its pipeline beyond traditional alpha-2 receptor agonists to compounds that would more selectively target specific subtypes of the alpha-2 receptor.
Alpha-2 receptors are present throughout the brain and body. They bind with adrenergic hormones and neurotransmitters such as adrenalin and noradrenalin to control a wide range of physiological functions. Malfunctions in the alpha-2 receptor pathway have been implicated in a wide range of conditions, including hypertension, pain, addiction, post traumatic stress disorder, menopausal symptoms, aggression and hyperactivity.
Yet few known drugs target the specific receptors involved in such conditions, Khayrallah said.
In December, Addrenex dramatically expanded its potential pipeline of drugs by licensing an existing library of 400 alpha-2 adrenergic compounds from UNeMed, the technology transfer arm at the University of Nebraska Medical Center. These compounds were originally developed by Procter & Gamble and later gifted to the university. Scientists at the university and Addrenex have already begun sifting through the data and examining compounds that appear to have selective affinity for the various alpha 2 receptor subtypes.
ADX415 was selected as a lead compound because of its receptor subtype profile and because it had undergone extensive preclinical and early clinical safety testing.
SOURCE Addrenex Pharmaceuticals