Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc.
(NASDAQ:MYGN), today announced positive results from a
double-blind, multi-center, randomized controlled trial assessing
the impact of the GeneSight® Psychotropic test (GeneSight) on
psychiatric treatment response in 1,200 patients with major
depressive disorder (MDD). GeneSight is the leading
pharmacogenomic test to help guide medication selection for mental
health disorders.
This was the largest ever pharmacogenomics depression trial and
primarily assessed Hamilton Depression Rating Scale 17
(HAMD-17) scores from baseline to eight weeks in patients receiving
GeneSight-guided therapy compared to those receiving
treatment-as-usual. The study was designed to evaluate three
key endpoints relative to HAMD-17 scores: remission (HAMD-17
score ≤7), response (HAMD-17 reduction >50%), and symptom
reduction.
Patients receiving the GeneSight test achieved a clinically
meaningful and statistically significant improvement in both
remission rates (p<0.01) and response rates (p=0.01) at eight
weeks compared to the treatment-as-usual group. In addition,
patients who received the GeneSight test had a greater reduction in
HAMD-17 scores after eight weeks, compared to the
treatment-as-usual group, with the difference approaching
statistical significance (p=0.1). Lastly, the improvement in
remission, response, and symptoms continued throughout the 24-week
study period, demonstrating the durability of the benefit through
that period. The data will be submitted for presentation at
the upcoming American Psychiatric Association’s (APA) annual
meeting in May 2018.
“From a clinician’s perspective, better but not well is not good
enough and significant improvements in response and remission are
always the most-desired endpoints,” said John Greden, M.D.,
Founding Chair of the National Network of Depression Centers
(NNDC). “We are eager to discuss complete results from this
study as well as potential future applications of pharmacogenomics
at the upcoming APA annual meeting in May 2018.”
“The robustness of the results are attributed to the unique
algorithm developed by our scientists that appropriately weights
and combines multiple pharmacogenetic factors impacting mental
health medication efficacy,” said Bryan Dechairo, Ph.D., executive
vice president of Clinical Development, Myriad Genetics.
“Improving remission and response rates are key treatment
goals of clinicians because they directly improve patients’ lives
and reduce healthcare costs. These endpoints also align with
payer goals, and we look forward to having those discussions in the
coming months.”
About the study designThe study is a 24 week,
double-blind, multi-center, randomized controlled trial that
evaluated 1,200 patients with moderate or severe MDD to assess the
impact of the GeneSight test on psychiatric treatment response
[NCT02109939]. Patients were randomized in a 1:1 ratio to the study
group (those receiving the GeneSight test) or the
treatment-as-usual group. Assessments were completed at
baseline and at 4, 8, 12, and 24 weeks, with patients and raters
completely blinded at the 4 and 8 week time points.
Unblinding occurred during week 12 of the study, when
treatment-as-usual patients were allowed to switch to
GeneSight-guided therapy for the remaining 12 weeks of the
study.
Assurex Milestone PaymentsThe sole endpoint to
trigger a clinical trial milestone payment to the former
stockholders of Assurex was a statistically significant (p<0.05)
greater reduction in HAMD-17 score from baseline to week eight of
the study in the GeneSight arm compared to the treatment-as-usual
arm. That clinical trial milestone payment will not be due
because this endpoint did not achieve statistical significance in
the entire study population. However, we continue to expect
that a revenue growth milestone payment (calendar year 2017 revenue
compared to calendar year 2016 revenue) will be paid to the former
stockholders of Assurex in our fiscal third quarter.
About GeneSightGeneSight is a
laboratory-developed pharmacogenomic test that uses cutting edge
technology to measure and analyze clinically important genomic
variants in the treatment of psychiatric disorders. The results of
the GeneSight report can help a clinician understand the way a
patient’s unique genomic makeup may affect certain psychiatric
drugs. The analysis is based on pharmacogenomics, the study of
genomic factors that influence an individual’s response to drug
treatments, manufacturers’ FDA approved drug labels, peer reviewed
scientific and clinical publications, and proven drug pharmacology.
Quick turnaround time, combined with a customized report of
the patient’s genomic makeup, clinical experience, and other
factors can provide information to help a physician make
personalized drug treatment choices for each patient. For more
information about GeneSight, please visit www.genesight.com.
About Assurex HealthAssurex Health, a
wholly-owned subsidiary of Myriad Genetics, Inc. is a personalized
medicine company that specializes in pharmacogenomics and is
dedicated to helping physicians determine the right medication for
individual patients with neuropsychiatric and other disorders.
Assurex Health was founded to commercialize industry-leading
personalized medicine technology for neuropsychiatric
disorders. For more information about Assurex Health, please
visit https://genesight.com/about-assurex-health/ .
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
three strategic imperatives: maintaining leadership in an
expanding hereditary cancer market, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. For more
information on how Myriad is making a difference, please visit
Myriad's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra DA, GeneSight, EndoPredict and Prolaris are
trademarks or registered trademarks of Myriad Genetics, Inc. or its
wholly owned subsidiaries in the United States and foreign
countries. MYGN-F, MYGN-G
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to submitting the data at the upcoming American
Psychiatric Association’s (APA) annual meeting in May 2018; the
importance of response and remission endpoints in a pharmaceutical
study for any antidepressant; the robustness of the results being
attributed to the unique algorithm developed by scientists that
appropriately weights and combines multiple pharmacogenetic factors
impacting mental health medication efficacy; significant
improvements in response and remission always being key endpoints;
the endpoints of response and remission also aligning with payer
goals; anticipated future discussions with payers in the
coming months; the expectation that no clinical trial milestone
payment will be due because the primary study endpoint did not
achieve statistical significance; the continued expectation that a
revenue growth milestone payment (calendar year 2017 revenue
compared to calendar year 2016 revenue) will be paid in Myriad’s
fiscal third quarter; and the strategic directives described under
the captions “About GeneSight,” “About Assurex Health,” and “About
Myriad Genetics.” These “forward-looking statements” are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those described or
implied in the forward-looking statements. These risks include, but
are not limited to: the risk that sales and profit margins of our
existing molecular diagnostic tests and pharmaceutical and clinical
services may decline or will not continue to increase at historical
rates; risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
governmental or private insurers’ reimbursement levels for our
tests or our ability to obtain reimbursement for our new tests at
comparable levels to our existing tests; risks related to increased
competition and the development of new competing tests and
services; the risk that we may be unable to develop or achieve
commercial success for additional molecular diagnostic tests and
pharmaceutical and clinical services in a timely manner, or at all;
the risk that we may not successfully develop new markets for our
molecular diagnostic tests and pharmaceutical and clinical
services, including our ability to successfully generate revenue
outside the United States; the risk that licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical services tests and any future tests are terminated or
cannot be maintained on satisfactory terms; risks related to delays
or other problems with operating our laboratory testing facilities;
risks related to public concern over genetic testing in general or
our tests in particular; risks related to regulatory requirements
or enforcement in the United States and foreign countries and
changes in the structure of the healthcare system or healthcare
payment systems; risks related to our ability to obtain new
corporate collaborations or licenses and acquire new technologies
or businesses on satisfactory terms, if at all; risks related to
our ability to successfully integrate and derive benefits from any
technologies or businesses that we license or acquire, including
but not limited to our acquisition of Assurex Health, Sividon
Diagnostics GmbH, and Privatklinik Dr. Robert Schindlbeck GmbH
& Co. KG; risks related to our projections about the potential
market opportunity for our products; the risk that we or our
licensors may be unable to protect or that third parties will
infringe the proprietary technologies underlying our tests; the
risk of patent-infringement claims or challenges to the validity of
our patents; risks related to changes in intellectual property laws
covering our molecular diagnostic tests and pharmaceutical and
clinical services and patents or enforcement in the United States
and foreign countries, such as the Supreme Court decision in the
lawsuit brought against us by the Association for Molecular
Pathology et al; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; and other
factors discussed under the heading “Risk Factors” contained in
Item 1A of our most recent Annual Report on Form 10-K, which has
been filed with the Securities and Exchange Commission, as well as
any updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.
Media
Contact: |
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Ron Rogers |
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Investor Contact: |
|
Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
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