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.