Local Start-Up Acquires Portfolio of Potential New Drugs Through License Agreement with the University of Nebraska Medical Cente

RESEARCH TRIANGLE PARK, N.C., Dec. 18 /PRNewswire/ -- Even in a region where start-up companies are synonymous with rapid growth, Addrenex Pharmaceuticals, Inc. has succeeded with unusual speed in attracting heavyweight partners from both the corporate and academic worlds.

Barely into its second year of operation, Addrenex has signed a licensing agreement with UNeMed Corporation, the technology transfer arm of the University of Nebraska Medical Center. The partnership will widely expand Addrenex's drug pipeline from a single product to myriad drugs aimed at medical conditions as diverse as hypertension, attention deficit hyperactivity disorder (ADHD), pain, menopausal symptoms, insomnia, and post traumatic stress disorder (PTSD).

The agreement with the University of Nebraska Medical Center is the company's second in six months. In July, Addrenex signed a licensing agreement with Sciele Pharma to market Clonicel, Addrenex's first product, upon FDA approval. The agreement with Sciele included $6 million in upfront equity, $11 million in potential milestones, and future royalty payments on product sales. Clonicel is a sustained release formulation of clonidine hydrochloride, a drug used to treat hypertension and ADHD.

The latest contract with the University of Nebraska Medical Center gives Addrenex exclusive rights to the university's library of nearly 400 compounds that target "adrenergic" receptors -- docking sites on cells that react with the hormones adrenalin and noradrenalin.

While the adrenergic system is best known for its role in triggering the "fight or flight" response, it is actually a vast and varied regulator of multiple processes, including blood pressure, mental health and well-being, energy levels and sleep, pain and addiction.

The alpha-2 adrenergic receptors in particular have been implicated in a wide variety of medical conditions such as hypertension, ADHD, post-menopausal symptoms, pain, aggression, sleep disorders, and PTSD.

However, only a handful of drugs currently on the market are known to target and restore the adrenergic system when it malfunctions, said Dr. Moise Khayrallah, co-founder and CEO of Addrenex. Clonidine is one such drug.

Addrenex sought the deal with the University of Nebraska Medical Center to rapidly acquire new drug candidates by tapping into the university's considerable scientific expertise and its pre-existing library of alpha-2 adrenergic compounds. The library and associated intellectual property were gifted to the university by Procter and Gamble in 2002. Two of the compounds have been tested in clinical trials involving 700 patients with either nasal congestion or migraine headache.

"If Addrenex succeeds in developing several lead compounds that target the adrenergic system, the potential sales from these products could exceed $2 billion dollars annually," said Khayrallah, a drug development expert with a track record of bringing drugs to market.

Under the current agreement, Addrenex will provide the university with milestone payments and future royalties on sales for drugs that are developed, approved and marketed. The specific terms were not disclosed.

"With this portfolio, we have a great tool to investigate adrenergic conditions from a multitude of angles," he added. "This collaboration with one of the premier research centers in this field will allow us to fine tune our intervention at the alpha-2 receptor pathway and address a much wider array of medical conditions than we would be able to address on our own."

The goal is to identify compounds that precisely target alpha-2 adrenergic receptors but not other receptors, thereby reducing the risk of side effects, said Dr. David Bylund, a professor in the Department of Pharmacology and Experimental Neuroscience at the University of Nebraska Medical Center.

Compounds that appear to have the greatest affinity for the alpha-2 receptor will be further tested for their actual effect on cells, within tissues, and eventually within animal models, he said.

Adrenergic receptors are present throughout the body and the brain, but their activity and impact on health and well being vary according to their number, subtype, and location in the body, he said. Different receptor subtypes serve different functions in the body.

For example, schizophrenia theoretically could be related to alpha-2A receptor, while pain could be associated with the alpha-2C receptor, he said.

"We are truly excited to tap into a virtually unexplored landscape of adrenergic regulation, a field where we can have a considerable impact on human health and well-being," said Khayrallah.

SOURCE Addrenex Pharmaceuticals, Inc.