Athena Introduces First Alzheimer's Disease-Specific Diagnostic Tests; ADmark Assays Redefine Diagnostic Protocol for Alzheimer's Disease.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--March 27, 1996--Athena Neurosciences, Inc. ("Athena") (Nasdaq:ATHN) announced today the introduction of the ADmark Assays, the first Alzheimer's disease-specific tests to aid neurologists in the differential diagnosis of Alzheimer's disease (AD).

The ADmark Assays have the potential to redefine the diagnostic protocol for AD, allowing neurologists to approach the diagnosis of AD by a process of inclusion, rather than exclusion.

The ADmark Assays are two AD-specific tests, to be used only with patients presenting with dementia. One partners two biochemical markers, Tau and beta-amyloid (A beta 42), to determine the levels of these substances in cerebrospinal fluid (CSF). The combined results of the Tau and A beta 42 assays can rule in or rule out AD with greater than 95% accuracy in approximately 60% of patients over the age of sixty presenting with dementia.

The second determines Apolipoprotein E (ApoE) genotype. Information on a patient's ApoE alleles provides statistically significant information on the probability that AD is the cause of the patient's dementia. The assays can be ordered separately or in a combined panel called the ADmark Profile. Although each test provides relevant information, the ADmark Profile offers the neurologist a more comprehensive evaluation of the patient's condition.

"Addressing the need for an effective diagnostic and therapeutic approach to Alzheimer's disease has been the driving force behind our work at Athena since the company's inception. The ADmark Assays mark a significant milestone in our company's mission. We are confident that these tests will not only change how neurologists approach the diagnosis of AD, but will also help us to better understand the causes of the disease as we search for a treatment," said John Groom, president and CEO of Athena.

The ADmark Tau/A beta 42 CSF Analysis and Interpretation, which measures the levels of Tau and A beta 42 in CSF, requires a lumbar puncture. The Tau protein is the key component of neurofibrillary tangles, a pathological hallmark of AD. The results of nine studies, with a total of 999 subjects, evaluating the correlation between Tau levels and AD, all showed elevated levels of Tau in the CSF of patients with AD.

The A beta 42 peptide, a specific form of the beta-peptide originally described by the late Dr. George Glenner, was identified in CSF by Athena and its collaborators in 1994. Produced following the metabolism of the beta-amyloid precursor protein, A beta 42 is now widely acknowledged as the key peptide which initiates the formation of amyloid plaques.

The deposition of amyloid in plaques is also an accepted pathological hallmark of AD. A recent clinical study showed that patients with AD have reduced levels of A beta 42 in CSF, and therefore, high levels of A beta 42 are a strong indicator that AD is not the cause of dementia. Based on these findings, the paired results of the Tau and A beta 42 levels in CSF can rule in or rule out AD for approximately 60% of the patients over 60 years of age presenting with dementia, with over 95% accuracy.

The relationship of ApoE to AD was first discovered by Dr. Allen D. Roses and colleagues at Duke University Medical Center. ApoE is a plasma protein involved in the transport of cholesterol and is encoded by a gene on chromosome 19. It is commonly expressed in three different forms, E2, E3 and E4, and individuals inherit one form or "allele" from each parent.

Dr. Roses's studies, confirmed by over 90 studies worldwide, show that the presence of at least one ApoE4 allele increases the probability that AD is the cause of a person's dementia. With two copies of the ApoE4 allele, the probability that AD is the cause of a patient's dementia increases to over 90%. This is not a predictive test and is only useful in establishing the cause of dementia in a symptomatic patient.

The existing diagnostic protocol for AD is a process of exclusion. Neurologists perform a battery of tests to attempt to diagnose AD by ruling out other possible causes of a patient's dementia including depression, drug interaction, stroke (vascular dementia/multi-infarct dementia), Parkinson's disease, diabetes, malignancy and endocrine/metabolic disorders. All of these other possibilities have similar symptoms to AD, making the diagnosis of AD very difficult. It is estimated that incorrect diagnosis ranges from 15% to 40%.

A typical patient work-up includes taking a patient's medical and family history, a physical and neurological examination, blood work and urinalysis, a mental status examination and selected imaging studies such as MRI, SPECT, CT or PET scans. The average cost of a typical work-up can range from $1,500 to $3,000 or more.

The current diagnosis can take anywhere from a few months to a few years. Because monitoring the progression of the patient's symptoms is one of the factors considered by neurologists, follow-up visits and additional tests are often necessary in order to arrive at a "probable" diagnosis of AD. By incorporating the ADmark Assays into a patient's work-up, the neurologist can obtain critical insight into the probable cause of a patient's dementia within a few weeks.

A more certain diagnosis of AD has both clinical and economic benefits. With an accurate diagnosis, a neurologist can better manage a patient's condition and avoid adverse reactions to certain medications. An earlier diagnosis can also provide more time for the patient and caregiver to plan financial and care options. Also, early identification of AD patients provides more data for clinical research and clinical trials of new therapies.

AD is a degenerative disorder of the brain that leads to progressive dementia (memory loss and impaired judgement, thinking, speech and orientation). It is the leading cause of dementia in the elderly in the United States, accounting for more than 55% of cases. There are an estimated 4 million people with AD in the U.S. and that number grows by 500,000 each year. It is projected that there will be at least 7 million people afflicted with AD by the 21st century.

The ADmark Assays are available exclusively through Athena Diagnostics (a subsidiary of Athena). Based in Worcester, MA, Athena Diagnostics provides over 50 testing services for a range of neurological disorders. Physicians, patients and their families can get more information about the ADmark Assays by calling 1-800/394-4493.

Athena Neurosciences, Inc. was founded in 1986 to discover, develop and market products to be used primarily by neurologists for the treatment and diagnosis of neurological disorders.

CONTACT: Athena Neurosciences, Inc.

Eric J. Liebler, 415/877-0900

or

Lehman Millet Public Relations

Helen Shik or Michelle Ertischek, 617/439-0288