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| | | ![]() Ceretec New Alzheimer's Diagnostic Agent Now Available PRINCETON, N.J., and OXFORD, England, April 1, 1996 -- Bristol-Myers Squibb Company (NYSE: BMY), the University of Oxford and Amersham International plc announced today a licensing agreement for an agent to be used in the antemortem diagnosis of Alzheimer's disease. Ceretec(R) (technetium Tc-99m) is a brain imaging agent developed by Amersham. It is now marketed for stroke worldwide and for dementia in Europe. The agreement allows for Amersham to file a Supplemental New Drug Application (SNDA) with the U.S. Food And Drug Administration for the use of Ceretec(R) in diagnosing neurodegenerative disorders of the Alzheimer's type. The SNDA will be based on data accumulated by Oxford University as part of a research alliance funded by Bristol-Myers Squibb to study neurodegenerative diseases. Terms of the agreement were not disclosed. Since late 1987, Bristol-Myers Squibb has funded the Oxford Project To Investigate Memory and Aging (OPTIMA). Among OPTIMA programs is exploring the sensitivity and specificity of two brain imaging technologies -- single photon emission-computed tomography (SPECT) and computed tomography (CT) -- used alone and in combination to detect Alzheimer's disease. Ceretec(R), an imaging agent commonly used with SPECT for brain imaging, was employed by OPTIMA's researchers during the development and validation of their methodology. OPTIMA has studied changes in the brain by these methods for eight years in over 300 patients and control groups who are being followed until death when a definitive diagnosis can be obtained by histopathology. "We're pleased that among the results of our collaboration with Oxford is a tool that may have a profound influence on the diagnosis of Alzheimer's disease and possibly on the development of new pharmaceutical agents used to treat dementia," said William A. Scott, Ph.D., senior vice president, Exploratory and Drug Discovery Research, Bristol-Myers Squibb Pharmaceutical Research Institute. "The OPTIMA project offers exciting new insights into the possible causes and treatment of Alzheimer's and dementia and we look forward to further developments from this alliance." Currently, the usefulness of diagnostic tests to detect Alzheimer's and other dementias has been limited and the only way to confirm a diagnosis of Alzheimer's disease is histopathological examinations during autopsy. Living patients are assumed to have Alzheimer's by eliminating other possible causes of their symptoms -- an inaccurate method that often results in errors. OPTIMA research demonstrates that the combination of SPECT and CT imaging agents using Ceretec(R) can detect Alzheimer's disease with a 90 percent accuracy rate and less than 5 percent false-positive rate. In addition, the imaging sensitivity may allow physicians to track the course of the disease and measure the patient's response to treatment. Lead investigators for the OPTIMA project are and A. David Smith, Ph.D., Professor of Pharmacology at Oxford University, and Kim Jobst, MRCP. The scientists said the improved accuracy of diagnosing Alzheimer's disease has important implications for the patients and their relatives, and for the selection of patients in clinical trials for new drugs. "These tests promise to reduce substantially the financial and human costs of misdiagnoses and subsequent use of inappropriate treatment that dramatically affects patients and their families," explained Professor Smith and Dr. Jobst. "It also allows for a more reliable assessment to be made of new drug therapies for Alzheimer's, which is especially important now that promising treatments are becoming available." Amersham said it plans to file the SNDA in the U.S. later this year. Bristol-Myers Squibb is a diversified, worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals, and medical devices. Its alliance with Oxford University involves more than $30 million committed to basic research in the neurosciences. Within the company's Pharmaceutical Research Institute, discovery efforts in central nervous system disorders include programs on Alzheimer's and Parkinson's diseases, depression, obesity, and sleep disorders. Amersham International plc is a world leader in nuclear medicine with products for diagnostic imaging and cancer therapy. Amersham health care products are manufactured and distributed in the United States through Medi-Physics Inc., Amersham Healthcare. Amersham is also the world's leading supplier of life science products for university and pharmaceutical research.
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