Genica Pharmaceuticals acquires exclusive rights to world's first diagnostic test for Alzheimer's disease.

WORCESTER, Mass.--(BUSINESS WIRE)--Nov. 10, 1994--Genica Pharmaceuticals Corp., a five-year-old profitable biotechnology company that specializes in developing diagnostics and therapeutics for neurological diseases, announced today that it has acquired the exclusive worldwide rights from Harvard University for an eye test that may diagnose Alzheimer's disease, the most common cause of dementia in adults.

The Alzheimer's diagnostic, an eye test developed at Harvard Medical School by Huntington Potter, Ph.D., and colleagues and protected by U.S. Patent No. 5,297,562 issued on March 29, 1994, may be "an early, non-invasive, sensitive, and easily administered diagnostic test of Alzheimer's disease," according to the study published in tomorrow's issue of SCIENCE. "Several findings from this study (also) suggest that... the test may be able to identify Alzheimer's patients prior to the onset of clinical symptoms of dementia."

In exchange for granting Genica exclusive worldwide rights to the eye test for Alzheimer's, Harvard has received an undisclosed equity position in privately held Genica, and will receive royalties on future sales of the test by Genica.

The test that Dr. Potter developed is the result of an observation he made on the similarities between patients with Down's syndrome and patients with probable Alzheimer's disease. He recognized that Down's individuals who live beyond 30 years develop the same brain lesions that characterize Alzheimer's disease and, in most cases, manifest a related dementia. This encouraged Dr. Potter to search for other physiological characteristics associated with Down's syndrome that also might be present in Alzheimer's disease.

Specifically, Dr. Potter found in the medical literature that Down's individuals exhibit a hypersensitivity to compounds that act as antagonists of acetylcholine neurotransmission, which can be measured by changes in heart rate or pupil size in response to those agents. The study published today in SCIENCE demonstrated dramatically that patients with clinically diagnosed Alzheimer's disease are in fact hypersensitive to the pupil-dilating effect of the acetycholine receptor antagonist, tropicamide. That feature is the basis of the eye test for Alzheimer's.

The test requires that an exact amount of a specially prepared solution of the cholinergic antagonist, tropicamide, be placed in one eye of the patient, and the rate of pupil dilation is measured using a pupillometer. To date, 58 Alzheimer's patients and control subjects have been tested, and the test has correctly identified 95 percent of patients who previously were clinically diagnosed with Alzheimer's disease.

"This could prove to be a giant leap forward for diagnosing this insidious and deadly disease. Nothing else is close," insists Michael A. Boss, Ph.D., Genica's director of research and development. "There is no truly differential test for Alzheimer's. It's a diagnosis of exclusion, often based on running lots of tests, an MRI, clinical exam, and evaluation of mental state with a psychological exam. Not only does the eye test that Dr. Potter developed seem to identify very accurately people who already have Alzheimer's disease, but it may provide some information for a period of time ahead of obvious clinical symptoms," adds Dr. Boss.

"Despite the relatively small sample size of the study, the results nonetheless are highly statistically significant," Dr. Boss added. "Genica now will work to expand the sample size and control for a variety of variables, including age, sex, medications, and severity of disease, in order to generate a database that can measure a specific patient's test results against the appropriate Alzheimer's disease sub-population."

Genica intends to market the test for Alzheimer's, initially, to neurologists by developing a small, inexpensive pupillometer and a single-dose application of the appropriately diluted cholinergic antagonist. It is expected that the pupillometer will be connected via modem to Genica's extensive database, against which the patient's results will be measured. Eventually, Genica intends to market the test beyond the neurology community. The company conservatively estimates that the U.S. market opportunity for the test exceeds $100 million annually. Genica expects the test to be introduced before the end of 1996, and is seeking corporate partners to assist in the development of this breakthrough technology.

Genica Pharmaceuticals Corp., a five-year-old and profitable biotechnology company based in Worcester, Mass., is focused exclusively on developing diagnostics and therapeutics that help physicians identify and manage some of the world's most subtle and baffling of human illnesess -- neurological disorders.

CONTACT: Genica Pharmaceuticals Corp., Worcester

              Dr. Michael A. Boss, 508/756-2886
                                or
              Ronald Trahan Associates,
              Ronald Trahan, 508/651-1180