Myriad and Pfizer Build Upon a Previously Announced Companion Diagnostic Agreement
October 09 2018 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced that it has signed a
commercialization plan with Pfizer Inc. The plan is under an
existing companion diagnostic agreement, in which Myriad is
pursuing U.S. Food and Drug Administration (FDA) approval for its
BRACAnalysis CDx® to be used as a companion diagnostic with
Pfizer’s investigational PARP (poly ADP ribose polymerase)
inhibitor, talazoparib.
Talazoparib and BRACAnalysis CDx currently are under FDA review,
with New Drug Application and Supplementary Premarket Approval
submissions based on results from the EMBRACA trial, which
evaluated talazoparib versus physician’s choice chemotherapy in
patients with germline (inherited) BRCA-mutated, HER2-negative
locally advanced or metastatic breast cancer. Myriad
anticipates a regulatory decision from the FDA by December
2018.
Under the commercialization plan, each company remains
responsible for the commercialization of its respective
product. However, the companies will collaborate on certain
commercial activities intended to support the use of the
BRACAnalysis CDx in identifying patients for potential treatment
with talazoparib following FDA approval.
"We believe this commercial collaboration is another strong
indication of Myriad’s global leadership in the field of companion
diagnostics for PARP inhibitors and personalized medicine," said
Lloyd Sanders, president of Myriad Oncology. "We are excited
to be working with Pfizer and towards ensuring patients have access
to this class of drugs."
Approximately one in eight women are diagnosed with breast
cancer in the U.S., and one-third are diagnosed with or will
progress to the metastatic stage of the disease.
About BRACAnalysis CDx®BRACAnalysis CDx is an
in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and
intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic
DNA obtained from whole blood specimens collected in EDTA.
Single nucleotide variants and small insertions and deletions
(indels) are identified by polymerase chain reaction (PCR) and
Sanger sequencing. Large deletions and duplications in BRCA1
and BRCA2 are detected using multiplex PCR. This assay is for
professional use only and is to be performed only at Myriad Genetic
Laboratories, a single laboratory site located at 320 Wakara Way,
Salt Lake City, UT 84108. Learn more at:
http://myriadmychoice.com/.
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
five strategic imperatives: build upon a solid hereditary
cancer foundation, growing new product volume, expanding
reimbursement coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. For more information on how Myriad is making a
difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris,
ForeSight and Prelude 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 related to the Company’s commercialization plan signed
with Pfizer for BRACAnalysis CDx as a companion diagnostic with
Pfizer’s talazoparib; the Company’s pursuit of FDA approval for its
BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s
investigational PARP (poly ADP ribose polymerase) inhibitor,
talazoparib; the anticipated timing and regulatory decision of the
Company’s New Drug Application and Supplementary Premarket Approval
submissions to the FDA for talazoparib and BRACAnalysis CDx; the
Company’s and Pfizer’s collaboration efforts on certain commercial
activities intended to support the use of the BRACAnalysis CDx in
identifying patients for potential treatment with talazoparib
following FDA approval; and the Company's strategic directives
under the caption "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 set forth in or implied by
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk that sales and profit margins of
our molecular diagnostic tests and pharmaceutical and clinical
services may decline; risks related to our ability to transition
from our existing product portfolio to our new tests, including
unexpected costs and delays; risks related to decisions or changes
in 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 and any future tests and services are terminated
or cannot be maintained on satisfactory terms; risks related to
delays or other problems with operating our laboratory testing
facilities and our healthcare clinic; 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; risks related to our projections about our
business, results of operations and financial condition; risks
related to the potential market opportunity for our products and
services; 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 or other
intellectual property; 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 for the
fiscal year ended June 30, 2018, 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. All information in
this press release is as of the date of the release, and Myriad
undertakes no duty to update this information unless required by
law.
Media Contact: Ron
Rogers
Investor Contact: Scott Gleason
(801) 584-3065
(801)
584-1143
rrogers@myriad.com
sgleason@myriad.com
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