Company Profile

Neurobiological Technologies, Inc. (NTI), is an emerging drug development company focused on the clinical development and regulatory approval of neuroscience drugs. Founded in 1987, it went public in February 1994.

The company develops neuroprotective and neuromodulatory agents to treat progressive neurological impairments characteristic of various nervous system disorders, including diabetic neuropathy, brain cancer, and AIDS dementia syndrome. Damaged neurons contribute significantly to functional impairment in many peripheral and central nervous system disorders, including chronic diseases such as diabetes, AIDS, and Alzheimer's disease. NTI is developing potential neuroprotective drugs to inhibit important pathways that lead to nerve cell damage, including calcium influx caused by glutamate leak (excitotoxicity) and cerebral edema (swelling of the brain).

NTI has completed a Phase IIB clinical trial in the U.S. of Memantine for diabetic neuropathic pain. As of January 2000, it completed enrollment in a double-blind, placebo-controlled Phase II clinical trial of Memantine for AIDS-related dementia funded by the National Institute of Health (NIH) and conducted by the AIDS Clinical Trials Group (ACTG), a clinical consortium funded by the National Institute of Allergy and Infectious Diseases (NIAID). In May 2001, the AIDS Clinical Trial Group presented positive trends at the American Academy of Neurology meeting for the use of Memantine as a treatment for AIDS-related dementia.

In April 1998, NTI entered into a strategic research and marketing alliance with Merz + Co. GmbH & Co. (Merz) of Frankfurt, Germany to further the development and commercialization of Memantine for diabetic neuropathy, brain cancer, and AIDS dementia. Merz has marketed Memantine in Germany since 1989 with the labeling "dementia syndrome."

In June 2000, Merz + Co. entered into an agreement with Forest Laboratories, Inc. for the development and marketing of Memantine in the United States for the treatment of Alzheimer's disease, neuropathic pain, and AIDS-related dementia.

In August 2000, Merz + Co. entered in an agreement granting H. Lundbeck A/S exclusive rights to market Memantine in certain European markets and in Canada, Australia and South Africa and semi-exclusive rights to co-market with Merz + Co. other markets worldwide excluding the United States. Lundbeck's strategic partner Forest Laboratories, Inc. holds the right to the U.S. market. Memantine is under development in Japan by Merz's collaborating partner Suntory Ltd.

NTI is developing XERECEPT™, its synthetic preparation of the natural human peptide Corticotropin-Releasing Factor (CRF), for reduction of cerebral edema associated with brain cancer (peritumoral brain edema). In April 1998, XERECEPT™ received orphan drug designation from the FDA for peritumoral brain edema. NTI completed analysis of a Phase II trial of XERECEPT™ and promising results were presented in San Diego at the annual meeting of the American Academy of Neurology in May 2000. In August 2000, NTI obtained an option to negotiate an exclusive license with the University of California, Berkeley for Berkeley's patents on corticotropin-releasing hormone analogs. NTI believes that XERECEPT™ may reduce brain swelling in peritumoral brain edema.