Addrenex licenses new hypertension treatment compound to Sciele Pharma

UK company Addrenex Pharmaceuticals 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 a hormone that triggers the "fight or flight" reaction in response stress or danger. But Addrenex scientists recognised 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 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 $6m in upfront equity, $11m in milestones, and future royalty payments on product sales.

One year later, the company has signed this second, larger deal, to include up to $27m in development and regulatory milestones and future royalty payments on product sales. In addition, Sciele will pay all development costs.

Ed Schutter, president and coo of Sciele Pharma, said,' This agreement further expands our relationship with Addrenex and provides the company with a product in Phase II clinical development, expanding our pipeline beyond 2010. This is the first new chemical entity (NCE) that will be developed by Sciele. We are optimistic about the potential of ADX415 for the treatment of hypertension.

'According to a recent report from the American Health Association, hypertension has developed resistance to existing drugs and has become increasingly difficult to treat. By analysing studies of patients with high blood pressure, an AHA panel concluded that 20% to 30% could not manage their condition with three or more medicines, even when used exactly as specified,' he added.

Addrenex began its foray into drug development by tweaking an existing drug, clonidine, to extend its benefits and reduce side effects. Company co-founder Joseph Horacek, 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.