BROOMFIELD, Colo., Nov. 18 Accera, Inc., a biotechnologycompany delivering breakthrough therapies in central nervous system (CNS)diseases, will launch Axona(TM) in the United States for Alzheimer's disease(AD) in the first quarter of 2009. The commercial launch of Axona will befunded by the company's recent Series C equity financing.
Axona is a new first-in-class medical food product for the clinicaldietary management of the metabolic processes associated with mild-to-moderateAD. Axona has been shown in randomized, placebo controlled clinical trials tosafely improve cognitive function and memory in patients diagnosed withmild-to-moderate AD. It will be marketed as an adjunctive therapy tocurrently approved AD drugs. Axona will be administered under physiciansupervision and dispensed by prescription, in accordance with applicable FDAregulations.
"The recent financing will allow us to launch Axona, a new and novelapproach to managing Alzheimer's disease," said Steve Orndorff, Ph.D., founderand CEO, Accera, Inc. "We have developed an experienced commercialmanufacturing, sales and marketing team that has a history of successfulcommercialization of numerous CNS drugs. This team is prepared for thechallenge of launching the first AD product in recent years with a newmechanism of action."
Accera's innovative, proprietary approach to AD targets the metabolicdefects and imbalances associated with, and indeed characterizing the disease.Numerous scientific studies have confirmed a dramatic drop in glucose uptakein certain affected areas of the brain. This hypometabolism starts 10 to 20years before any symptoms of AD appear. The decrease in metabolism maycontribute to both the clinical and pathological course of the disease.Accera's research has shown that addressing these metabolic deficiencies mayreduce the devastating effects of AD and help manage the disease.
Axona will be distributed nationwide and available through retailpharmacies by prescription. Accera is currently seeking partners tocommercialize Axona outside the United States.
About Alzheimer's Disease
Alzheimer's disease, the most common form of dementia, is a progressiveand fatal disease for which there is no cure. In the United States, 5.2million people are living with AD, and it has become the sixth leading causeof 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 CaregiverAlliance estimates that approximately 80 percent of caregivers provide unpaidassistance seven days a week. With the lack of innovative new medications forAD, both patients and caregivers are seeking alternatives to improve qualityof life.
About Medical Foods
A Medical Food is an FDA-regulated product, in a relatively new categoryof medical protocols defined by Congress as part of the Orphan Drug Act. AMedical Food is formulated to be consumed or administered enterally under thesupervision of a physician and is intended for the specific dietary managementof a disease or condition for which distinctive nutritional requirements,based on recognized scientific principles, are established by medicalevaluation. Medical Foods can be prescription products, but are different thandrugs or dietary supplements (also called nutraceuticals) in several aspects,such as their claims. Claims for both Medical Foods and drugs must besupported by solid laboratory and clinical data. Medical Food ingredients haveGenerally Recognized As Safe (GRAS) designation, the highest FDA standard ofsafety given to foods. Medical Foods, sometimes prescribed in addition todrugs, nonetheless represent an entirely different scientific and medicalapproach to managing diseases.
About Accera, Inc.
Accera, Inc., a privately held biotechnology company, discovers anddevelops product breakthroughs in treating central nervous system disorders.Accera's novel therapeutic approaches positively impact patients withneurodegenerative disorders, who are in need of effective, well-toleratedtreatments. Through its proprietary scientific platform, Accera is developingtherapies that address metabolic deficiencies by providing an alternativeenergy source to the brain. For more information, visithttp://www.accerapharma.com.Contacts Media: Investors: Kelley Carpiac Steve Orndorff, Ph.D. MS&L Worldwide Accera, Inc. Ph: (323) 866-6003 Ph: (303) 999-3710 firstname.lastname@example.org
SOURCE Accera, Inc.