June 5, 2003

FOR IMMEDIATE RELEASE

Contact:
Leslie Priest (202) 955-6222
lpriest@spectrumscience.com

Mark A. De Fries (301) 795-2300
mdefries@Nutriciana.com

MEDICAL FOOD IS EFFECTIVE TREATMENT FOR ANTIPSYCHOTIC DRUG-RELATED TARDIVE DYSKINESIA

Study Demonstrates TARVIL^TM Can Reduce Symptoms By As Much As 86 Percent in Males

(Rockville, MD, June 5, 2003) - TARVIL^TM, a new product used to treat symptoms of tardive dyskinesia (TD) in men, effectively reduced abnormal, involuntary body movements in male study patients by as much as 86 percent, according to a study published in the June issue of the American Journal of Psychiatry.

TARVIL, a medical food^* distributed by Nutricia North America, uses branched chain amino acids (BCAA) to decrease symptoms of TD, a neurological disorder that is secondary to the antipsychotic medications used to treat severe mental illness such as schizophrenia. TD symptoms can range from mild to severe, based on the frequency and intensity of involuntary abnormal movements of the face, mouth and extremities. TD symptoms can include repetitive movements of the tongue, such as protrusions; of the jaw, such as chewing; and of the fingers, such as flicking. In severe states, movements, such as choreo-athetodic tongue movements, can be seen at the rate of 66 per minute.

Participants in the study were videotaped and study authors then viewed the tape to count the frequency of TD movements for each patient. Participants were randomly assigned to placebo or three different doses of the BCAA-based medical food TARVIL, administered three times a day for three weeks. Patients were kept on their same dose of antipsychotic medications from two weeks before the trial until trial completion. Movements were videotaped after the first dose of TARVIL and after one, two and three weeks of treatment. At the end of the study period, the group that received the high dose of TARVIL experienced a mean decrease of 36.5 percent in TD movements that was significantly different than the increase of 3.9% in TD movements seen for the placebo group. A third of the TARVIL high dose group experienced a 60 percent drop in TD movements.

Clinical research findings have shown that a decreased ability to clear the amino acid phenylalanine from the plasma is associated with symptoms of TD in men. It is also known that ingestion of branched chain amino acids reduces plasma levels of phenylalanine and its availability to the brain. Mary Ann Richardson, Ph.D., lead author of the study, said TARVIL is a highly effective and safe treatment for symptoms of TD.

"Patients using the product experienced significant improvement, with minimal side effects," she said. Richardson is director of the Movement Disorders and Molecular Psychiatric Division of the Nathan S. Kline Institute for Psychiatric Research, New York State Office of Mental Health in Orangeburg, N.Y. and a Professor of Psychiatry at New York University Medical School.

Some patients experienced a reduction in TD symptoms as soon as one week after treatment with TARVIL, and a patient's time in the study did not significantly impact his response. Richardson suggests that TD symptom response could extend beyond the three-week study timeframe. Longer-term studies would be useful, she said, as well as studies on whether TARVIL can be an effective treatment for TD for women in certain age groups.

"Patients with serious mental illnesses whose conditions are effectively treated by antipsychotic medications face a dilemma when they experience symptoms of TD. Those with severe TD find the unwanted movements so distressing that they may be tempted to discontinue treatment," said Mark De Fries, CEO of Nutricia North America. "To add to this medical dilemma, TD symptoms can persist even after the medication is stopped. This study demonstrates that TARVIL can help alleviate TD symptoms without altering treatment with antipsychotic medications."

Studies have determined that TD develops in 15 to 20 percent of patients taking antipsychotic medications for several years - as many as 1 million people in the United States.

TARVIL is a powdered drink mix with a pineapple flavor. As a medical food, TARVIL must be administered under the supervision of a physician three times a day, with dosing titrated to the patient's body weight and medical condition.

Nutricia North America, located in Rockville, MD, is a recognized world leader in specialized clinical nutrition. The company markets and distributes medical foods for the dietary management of metabolic, allergic, gastrointestinal and neurological disorders. Other products include Neocate^®, an amino acid-based, hypoallergenic infant formula for cow milk allergy and multiple food protein intolerance, and Periflex^® and Phlexy-10^®, both medical foods for the dietary management of phenylketonuria (PKU).

For more information, visit www.tarvil.com or call 1-877-482-7845.

* Medical foods are defined by the FDA as foods that are formulated to be consumed orally or administered enterally under the supervision of a physician and are intended for the dietary management of a specific disease or condition that has nutritional requirements.

Food and Drug Administration, HHS 21 CFR Ch.1 (4-1-95 Edition) § 101.9