Lincoln Journal Star

UNMC licenses drugs to North Carolina Triangle company

The Lincoln Journal Star | Posted: Monday, December 17, 2007 6:00 pm

Addrenex Pharmaceuticals, Inc., of Durham, N.C., on the edge of Research Triangle Park, has signed a licensing agreement with UNeMed Corp., the technology transfer arm of the University of Nebraska Medical Center.

The partnership is supposed to widely expand Addrenex’s drug pipeline from a single product to multiple drugs aimed at medical conditions as diverse as hypertension, attention deficit hyperactivity disorder. pain, menopausal symptoms, insomnia, and post traumatic stress disorder.

Under the agreement, Addrenex said it 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.

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. Clonicel is a sustained release formulation of clonidine hydrochloride, a drug used to treat hypertension and attention deficit hyperactivity disorder.

The new contract with the University of Nebraska Medical Center gives Addrenex exclusive rights to the university’s library of nearly 400 compounds aimed at “adrenergic” receptors — docking sites on cells that react with the hormones adrenalin and noradrenalin.

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

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 post-traumatic stress disorder.

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

Addrenex said it sought the deal with the University of Nebraska Medical Center to rapidly acquire new drug candidates by tapping into the university’s scientific expertise and its library of alpha-2 adrenergic compounds. The library and associated intellectual property were gifts to the university from Procter and Gamble in 2002.  Two of the compounds have been tested in clinical trials of 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 annually,” said Khayrallah.

“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.

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.

“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.

Addrenex Pharmaceuticals was formed in June 2006.