Myriad's 24-Month Study of Flurizan Demonstrates Significant Benefit in Alzheimer's Disease Patients

Flurizan Delays Time to Psychiatric Events by Over 7 Months

Jul 19, 2006, 01:00 ET from Myriad Genetics, Inc.

    SALT LAKE CITY, July 19 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc.
 (Nasdaq:   MYGN) ( announced today that results of its
 completed Phase 2 follow-on study of Flurizan(TM) in patients with mild
 Alzheimer's disease were presented at the 10th International Conference on
 Alzheimer's Disease and Related Disorders, in Madrid, Spain, by Dr. Gordon
 Wilcock, Professor of Clinical Gerontology, Nuffield Department of
 Medicine, University of Oxford, and lead investigator for the Phase 2
 trial. The data suggest that study participants taking 800 mg BID of
 Flurizan demonstrated a substantial benefit over other dose groups in the
 study and that this benefit continued to increase over 24 months, for each
 of the evaluated areas of cognition, memory loss, global function and
 activities of daily living.
     The data also suggest that during the follow-on period from months 12
 to 24, the benefit of Flurizan increases in terms of both effect size and
 significance, the longer patients remain on Flurizan. At month 24, patients
 taking 800 mg of Flurizan BID had an effect size of 72%, with a highly
 significant value of p=0.0005, as measured by their global function on the
 CDR-sb test. In terms of the performance of activities of daily living
 (ADCS-ADL) at 24 months, the patients showed a 67% effect size, with a
 value of p=0.015, which is also significant. Flurizan is improving the rate
 of cognitive decline also, as shown by the effect size of 52% at 24 months
 on the ADAS-cog scale. These data suggest that there was a substantial
 benefit from Flurizan on activities of daily living and global function,
 and that the benefit was increasing over time.
     The vast majority (~94%) of patients in this Phase 2 study, at the time
 of enrollment, were receiving stable doses of acetylcholinesterase
 inhibitors, FDA-approved drugs for symptomatic treatment of Alzheimer's
 disease, at the time of enrollment. Thus, the benefits of Flurizan observed
 in these patients were over and above the current standard of care.
     "The 24 month data completes the Phase 2 follow-on trial with mounting
 evidence of efficacy against mild Alzheimer's disease that consistently
 increased over the course of the study," said Adrian Hobden, Ph.D.,
 President of Myriad Pharmaceuticals, Inc. "The results are consistent with
 a mode of action for Flurizan that is modifying the course of the
 underlying disease process."
     Importantly, the Phase 2 trial also studied the occurrence and timing
 of serious psychiatric events in patients with Alzheimer's disease. The
 occurrence of psychiatric problems such as agitation, aggression,
 confusional state and depression was monitored throughout the study. Over
 the course of the 12-month study, approximately 35% of participants taking
 placebo experienced such an event. However, patients on 800 mg BID Flurizan
 experienced a 60% reduction in psychiatric events (14%, p=0.020) compared
 to those on placebo and the time to such an event was significantly longer
 with patients on Flurizan than those on placebo (333 days vs. 106 days, a
 difference of over 7 months, p=0.011). These data provide an indication
 that their disease had progressed more slowly than those on placebo.
     "The decrease in the number of psychiatric events and the dramatic
 lengthening in time before patients experienced such events while on
 Flurizan is an important feature for spouses and caregivers of Alzheimer's
 patients, as well as for the patients themselves," said Jacobo Mintzer,
 M.D., Professor in the Departments of Psychiatry and Neurosciences and
 Director of the Alzheimer's Disease Program at the Medical University of
 South Carolina, who is presenting the psychiatric event findings at the
 conference. "These events can be as troubling as the more widely recognized
 memory loss and decline in cognition to those involved in the devastating
 deterioration caused by Alzheimer's disease."
     After completion of Myriad's 12-month Phase 2 trial of Flurizan, study
 participants who had previously received placebo during the Phase 2 trial
 were randomized into the 400 mg BID group or the 800 mg BID group. In this
 "randomized start" design, former placebo patients were then followed for
 an additional 12 months. Results from this analysis indicate that patients
 treated with 800 mg twice daily of Flurizan for 24 months decline more
 slowly with regard to cognition, activities of daily living, and global
 function than those treated with the same dose for just 12 months in the
 follow-on study. Additionally, those former placebo patients who were
 randomized onto 800 mg Flurizan twice daily declined more slowly than those
 randomized onto 400 mg on both the ADAS-cog and the CDR-sb measures of
 disease progression. On the ADCS-ADL measure, the two groups experienced a
 comparable decline. Unlike currently marketed drugs for Alzheimer's
 disease, which show only symptomatic benefit, there was no indication that
 patients who had been on placebo for 12 months would catch up to patients
 treated for all 24 months. We believe these results are consistent with the
 hypothesis that Flurizan may have disease modifying properties and that the
 longer patients with mild Alzheimer's disease are treated with Flurizan,
 the slower their disease will progress.
     Announcing Myriad's Global Phase 3 Trial of Flurizan in Alzheimer's
     Myriad has begun to enroll a Global Phase 3 trial in patients with mild
 Alzheimer's disease including investigators in Italy, France, Germany,
 Spain, Sweden, Switzerland, the United Kingdom, Netherlands, the United
 States, Belgium, Canada and Denmark. The trial will enroll approximately
 800 participants into two groups, 800 mg twice daily and placebo, and the
 participants will receive treatment for 18-months.
     "We are encouraged by the promising data from our Phase 2 study of
 Flurizan in patients with Alzheimer's disease," said Peter Meldrum,
 President and Chief Executive Officer of Myriad Genetics, Inc. "Based on
 that data, we have advanced our development plans and are pleased to
 announce that Myriad has enrolled its first patients in a new global Phase
 3 trial."
     Myriad is also enrolling patients with mild Alzheimer's disease into a
 Phase 3 trial, at 130 centers across the United States. This enrollment is
 well advanced and is expected to be complete this summer. The Phase 3 trial
 is a double blind, placebo-controlled trial. Patients will be randomized
 into one of two groups, receiving either 800 mg of Flurizan or placebo
 twice daily for the duration of the 18-month trial period. The study is
 designed to determine Flurizan's ability to reduce the rate of cognitive
 decline and activities of daily living in patients with mild Alzheimer's
 disease, as measured by ADAS-cog and ADCS-ADL, respectively. Information on
 participation is available by calling (888) 459-4888.
     About Flurizan
     Flurizan is the first in a new class of drug candidates known as
 Selective Amyloid beta-42 Lowering Agents (SALAs). Flurizan lowered levels
 of Abeta42 in cellular assays and animal models. Abeta42 is the primary
 constituent of senile plaque that accumulates in the brain of patients with
 Alzheimer's disease. It is thought to be the key initiator of Alzheimer's
 disease, since Abeta42 has the greatest tendency to aggregate, cause
 neuronal damage and initiate amyloid deposits in the brain. Most genetic
 mutations that cause early-onset Alzheimer's disease appear to do so by
 increasing production of Abeta42. Myriad believes that Flurizan is the most
 advanced drug candidate that modifies the production of Abeta42 to be
 evaluated in a clinical trial for the treatment of Alzheimer's disease.
     About Myriad
     Myriad Genetics, Inc. is a biopharmaceutical company focused on the
 development and marketing of novel healthcare products. The Company
 develops and markets molecular diagnostic products, and is developing and
 intends to market therapeutic products. Myriad's news and other information
 are available on the Company's Web site at
     Flurizan is a trademark of Myriad Genetics, Inc. in the United States
 and other countries.
     This press release contains "forward-looking statements" within the
 meaning of the Private Securities Litigation Reform Act of 1995. These
 forward looking statements include: the suggestion that study participants
 taking 800 mg BID of Flurizan demonstrated a substantial benefit over other
 dose groups in the study and that his benefit continued to increase over 24
 months; the suggestion that continued treatment with Flurizan will provide
 continued and increasing benefits in both effect size and significance in
 patients with mild Alzheimer's disease the longer patients remain on
 Flurizan; that Flurizan offers benefits over and above the current standard
 of care; the decrease in psychiatric effects and the indication that
 Alzheimer's disease progresses more slowly for patients on Flurizan; the
 belief that Flurizan may have disease modifying properties and that the
 longer patients with mild Alzheimer's disease are treated, the slower their
 disease will progress; the appearance that Flurizan is modifying the
 underlying course of the disease process; the continued encouragement of
 the Company by the potential of Flurizan to treat mild Alzheimer's disease;
 the anticipated completion of enrollment in the Phase 3 trial in order to
 confirm similar efficacy results for Flurizan in a larger population; the
 enrollment of patients with mild Alzheimer's disease in a global Phase 3
 trial; the continued, on schedule, enrollment of patients with mild
 Alzheimer's disease in the Company's Phase 3 trial at 130 U.S. sites; the
 design of the Phase 3 study, and the ability of the Phase 3 study, to
 successfully determine Flurizan's ability to alter the course of cognitive
 decline and functional change in patients with mild Alzheimer's disease as
 measured by the ADAS-cog test, and the change in ADCS-ADL, respectively;
 and the belief that Flurizan is the most advanced drug candidate in a
 clinical trial that inhibits the production of Abeta42 to be evaluated in a
 clinical trial for the treatment of Alzheimer's disease. These forward
 looking statements are based on management's current expectation and are
 subject to certain risks and uncertainties that could cause actual results
 to differ materially from those set forth or implied by forward-looking
 statements. These include, but are not limited to, uncertainties as to the
 extent of future government regulation of Myriad Genetics' business;
 uncertainties as to whether Myriad Genetics and its collaborators will be
 successful in developing, and obtaining regulatory approval for, and
 commercial acceptance of, therapeutic compounds; the risk that markets will
 not exist for therapeutic compounds that Myriad Genetics develops or if
 such markets exist, that Myriad Genetics will not be able to sell
 compounds, which it develops, at acceptable prices; and the risk that the
 Company will not be able to sustain revenue growth for its predictive
 medicine business and products. These and other risks are identified in the
 Company's filings with the Securities and Exchange Commission, including
 the Company's current Report on Form 8-K filed October 28, 2005. All
 information in this press release is as of July 19, 2006 and Myriad
 undertakes no duty to update this information unless required by law.

SOURCE Myriad Genetics, Inc.