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New Treatment Method for Alzheimer's Disease

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By Press Rlease • • March 2, 2000

IRVINE, Calif., Feb. 23 /PRNewswire/ -- NeoTherapeutics, Inc. announced today that the Company has been issued a new U.S. patent covering a method for controlling the expression of genes to produce neurotrophic growth factors to stimulate nerve cell growth within the human body. This patent further secures NeoTherapeutics' proprietary position in nerve regeneration.

"This is one of many exciting new advances in the dynamic medical field of nerve regeneration," commented Dr. Michelle Glasky, Vice President, Scientific Affairs of NeoTherapeutics. "This patent covers one of the actions of NEOTROFIN(TM), that of causing nerve sprouting, which our research studies suggest may lead to the formation of new nerve connections. We believe that this effect is of vital importance to the functional regeneration of the nervous system."

U.S. Patent No. 6,027,936 describes how certain purine derivatives, a class of drug compounds which includes NeoTherapeutics' lead compound NEOTROFIN(TM) (AIT-082, leteprinim potassium), stimulate neuritogenesis, or the sprouting of nerve cells, by selectively and controllably inducing the in vivo genetic expression of at least one naturally occurring genetically- encoded molecule. NEOTROFIN(TM) induces the production of several different types of "nerve growth" factors in the central nervous system and it is these factors which are important for the growth, maturation and sprouting of nerve cells. Recent research has indicated that the ability to induce nerve growth factors may be important in treating neurodegenerative diseases including Alzheimer's disease.

Previously, the United States Patent and Trademark Office granted NeoTherapeutics three patents covering the Company's technology platform, which includes NeoTherapeutics' lead drug candidate, NEOTROFIN(TM). NeoTherapeutics has seven additional patent applications pending in the U.S. as well as patent applications in development for additional technologies. NeoTherapeutics has also filed, and in some cases received, international patent applications corresponding to its U.S. patents to further expand its technology base.

NEOTROFIN(TM) is being developed for nerve repair and regeneration, with Alzheimer's disease as its first clinical indication. Pre-clinical studies have demonstrated that NEOTROFIN(TM) causes the production of multiple natural nerve growth (neurotrophic) factors and restores function in animal models of cognitive decline, aging, neurodegeneration, and spinal cord injury. Human clinical studies have shown NEOTROFIN(TM) to be safe and tolerable and demonstrated its positive effects on memory and behavioral function in patients with Alzheimer's disease.

According to figures from the Alzheimer's Association, Alzheimer's disease presently affects over 4 million people in the U.S. and approximately 12 million patients worldwide, with associated health care costs of $80-$100 billion per year. Currently marketed drugs, such as Pfizer's Aricept(R) and the soon to be marketed Exelon(R) (Novartis), have been approved to slow the progression of symptoms of Alzheimer's disease.

NeoTherapeutics research program is focused on designing and developing small molecules capable of treating a range of neurological diseases and conditions such as Alzheimer's and Parkinson's diseases, stroke, and spinal cord injury.

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