Accera to launch Axona, medical food product for Alzheimer's in 2009

Accera, Inc. will launch Axona in the United States for Alzheimer's disease (AD) in the first quarter of 2009.

The commercial launch of Axona will be funded by the company's recent Series C equity financing.

Axona is a new first-in-class medical food product for the clinical dietary management of the metabolic processes associated with mild-to-moderate AD. Axona has been shown in randomized, placebo controlled clinical trials to safely improve cognitive function and memory in patients diagnosed with mild-to-moderate AD. It will be marketed as an adjunctive therapy to currently approved AD drugs. Axona will be administered under physician supervision and dispensed by prescription, in accordance with applicable FDA regulations.

"The recent financing will allow us to launch Axona, a new and novel approach to managing Alzheimer's disease," said Steve Orndorff, Ph.D., founder and CEO, Accera, Inc. "We have developed an experienced commercial manufacturing, sales and marketing team that has a history of successful commercialization of numerous CNS drugs. This team is prepared for the challenge of launching the first AD product in recent years with a new mechanism of action."

Accera's innovative, proprietary approach to AD targets the metabolic defects and imbalances associated with, and indeed characterizing the disease. Numerous scientific studies have confirmed a dramatic drop in glucose uptake in certain affected areas of the brain. This hypometabolism starts 10 to 20 years before any symptoms of AD appear. The decrease in metabolism may contribute to both the clinical and pathological course of the disease. Accera's research has shown that addressing these metabolic deficiencies may reduce the devastating effects of AD and help manage the disease.

Axona will be distributed nationwide and available through retail pharmacies by prescription. Accera is currently seeking partners to commercialize Axona outside the United States.

Alzheimer's disease, the most common form of dementia, is a progressive and fatal disease for which there is no cure. In the United States, 5.2 million people are living with AD, and it has become the sixth leading cause of death. The disease attacks the brain's cells, resulting in loss of memory, executive function and language skills.

AD significantly impacts millions of family members and other caregivers -- mentally, physically and financially. The national Family Caregiver Alliance estimates that approximately 80 percent of caregivers provide unpaid assistance seven days a week. With the lack of innovative new medications for AD, both patients and caregivers are seeking alternatives to improve quality of life.

A Medical Food is an FDA-regulated product, in a relatively new category of medical protocols defined by Congress as part of the Orphan Drug Act. A Medical Food is formulated to be consumed or administered enterally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical Foods can be prescription products, but are different than drugs or dietary supplements (also called nutraceuticals) in several aspects, such as their claims. Claims for both Medical Foods and drugs must be supported by solid laboratory and clinical data. Medical Food ingredients have Generally Recognized As Safe (GRAS) designation, the highest FDA standard of safety given to foods. Medical Foods, sometimes prescribed in addition to drugs, nonetheless represent an entirely different scientific and medical approach to managing diseases.