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Accera and the University of Miami Miller School of Medicine Announce Collaboration to Study Axona® for Cognitive Impairment in Patients with Multiple Sclerosis

April 9, 2013

Broomfield, CO, April 9, 2013 – Accera, Inc., a privately-held, commercial-stage, healthcare company focused on the discovery and development of innovative clinical applications to address acute and chronic neurodegenerative diseases, announced today a study in collaboration with the University of Miami Miller School of Medicine. The study will examine the effects of Accera's medical food, Axona, on cognitive impairment in patients with multiple sclerosis (MS). Axona is a prescription medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease (AD). Drs. Melissa Ortega and Heather Katzen, two researchers at the Miller School, will serve as the primary investigators of the study. The project will be funded by Fast Forward, LLC, a nonprofit organization established by the National Multiple Sclerosis Society.

More than 2.1 million people are affected by MS worldwide, and cognitive problems commonly occur in individuals with MS. Symptoms vary in severity and may have a negative impact on relationships, work and quality of life. There are few treatment options available and there is a pressing need for new interventions for cognitive impairment in MS. The UM Miller School of Medicine and Accera, with support from Fast Forward, LLC, will be testing Axona as a unique strategy for improving cognitive function in individuals with MS to address this disabling symptom.

Axona, made from special fats, produces ketones, which can provide an alternative energy source for brain cells. While typically the human brain relies on glucose as an energy source, research shows that individuals with AD fail to metabolize glucose properly. The decrease in glucose use correlates with cognitive impairment associated with the disease. In clinical trials, Axona was associated with cognitive improvement in people with mild to moderate AD. Previous research suggests there may also be flaws in how glucose is metabolized in the brains of individuals with MS. The notion that these metabolic abnormalities may be contributing to cognitive dysfunction in MS is what led Dr. Ortega, a neurologist who specializes in MS, to consider whether Axona may provide a therapeutic strategy to treat MS-related cognitive problems. To investigate whether Axona can help restore cognitive function in MS patients, this double-blind, randomized, placebo-controlled study will enroll 158 MS patients at the UM Miller School of Medicine MS Center over the next three years who have experienced cognitive problems.

"We are very excited about this project," said Holger Kunze, CEO at Accera. "This collaboration fits well with Accera's mission to help patients with neurological disorders by addressing metabolic deficiencies common in these disease states."

About Axona™

Axona is a prescription-only medical food intended for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer's disease. For more information about Axona, please visit www.about-axona.com.

About Medical Foods

A medical food is a product intended for the clinical dietary management of a disease or condition for which distinctive nutritional requirements are established scientifically. Medical foods are intended to be used under physician supervision, must be composed of approved food ingredients or generally recognized as safe and must comply with FDA regulations and guidelines that pertain to labeling, product claims and manufacturing.

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