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
Salt Lake City, July 19, 2006—Myriad Genetics, Inc.
(Nasdaq: MYGN)
(www.myriad.com) announced today that results of its completed
Phase 2 follow-on study of Flurizan™ 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
Disease
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 www.myriad.com.
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.
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