Myriad Genetics, Inc. (NASDAQ:MYGN) and Clovis Oncology, Inc.
(NASDAQ:CLVS) today announced a companion diagnostic collaboration
to support a post-marketing regulatory commitment related to
Clovis’ PARP inhibitor, Rubraca. Financial terms of the deal
were not disclosed.
Under the agreement, Myriad will submit a supplementary
premarket approval (sPMA) application under its existing PMA for
BRACAnalysis CDx to include Rubraca. The Myriad sPMA
submission will fulfill a post-approval regulatory commitment by
Clovis Oncology to the Food and Drug Administration (FDA) for
Rubraca. In December 2016, Rubraca was approved for women
with advanced ovarian cancer who have been treated with two or more
chemotherapies and whose tumors have a deleterious BRCA mutation as
identified by an FDA-approved companion diagnostic test. The
companion diagnostic test approved with Rubraca does not
discriminate between germline and somatic mutations.
Knowledge of germline status is important to provide patients
appropriate counseling.
“BRACAnalysis CDx is the only germline companion diagnostic test
approved by the FDA to identify patients with BRCA1/2 mutations,
and we are excited to support Clovis’ clinical development program
and help identify patients who are most likely to benefit from
rucaparib,” said Mark C. Capone, president and CEO, Myriad
Genetics. “This agreement further solidifies Myriad’s
leadership role in developing best-in-class companion diagnostics
for use with PARP inhibitors and supports our goal of being the
worldwide leader in personalized medicine.”
“This partnership with Myriad Genetics not only enables us to
fulfill our post-marketing commitment to the FDA, but will enhance
the companion diagnostic information already available to
physicians and patients, providing a robust toolkit for
personalizing treatment of patients with BRCA1/2 mutations,” said
Patrick J. Mahaffy, president and CEO, Clovis Oncology.
About Rubraca® (rucaparib) Rubraca is a PARP
inhibitor indicated as monotherapy for the treatment of patients
with deleterious BRCA mutation (germline and/or somatic) associated
advanced ovarian cancer, who have been treated with two or more
chemotherapies, and selected for therapy based on an FDA-approved
companion diagnostic for Rubraca. The indication for Rubraca is
approved under the FDA’s accelerated approval program based on
objective response rate and duration of response, and is based on
results from two multicenter, single-arm, open-label clinical
trials. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in
confirmatory trials. Please visit rubraca.com for more
information.
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. BRACAnalysis CDx
was reviewed and approved by the FDA in December 2014 for use as a
companion diagnostic to aid in identifying ovarian cancer patients
eligible for treatment with AstraZeneca’s PARP inhibitor,
olaparib. 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.
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: transitioning and expanding its
hereditary cancer testing markets, 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 the
Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan,
BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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
Myriad 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 Myriad’s companion diagnostics research
collaboration with Clovis Oncology to support the development of
rucaparib; Myriad’s planned submission of a supplementary premarket
approval (sPMA) application under Myriad’s existing PMA for
BRACAnalysis CDx to include Rubraca; the ability of Myriad’s
BRACAnalysis CDx to help identify patients with ovarian
cancer who are likely to respond to treatment with rucaparib;
Myriad’s commitment to innovation in the field of oncology; and
Myriad'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; 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, 2015, 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.
About Clovis Oncology Clovis Oncology, Inc. is a
biopharmaceutical company focused on acquiring, developing and
commercializing innovative anti-cancer agents in the U.S., Europe
and additional international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops, with partners, diagnostic tools that
direct a compound in development to the population that is most
likely to benefit from its use. Clovis Oncology is headquartered in
Boulder, Colorado, and has additional offices in San Francisco,
California and Cambridge, UK.
Clovis Oncology Safe Harbor StatementTo the
extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995. Such forward-looking statements involve substantial
risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from that
expressed or implied by the forward-looking statements. Such
risks and uncertainties include, among others, the uncertainties
inherent in the market potential of our approved drug, including
the performance of our sales and marketing efforts and the success
of competing drugs, the performance of our third-party
manufacturers, our clinical development programs for our drug
candidates, including the results of clinical trials, the
corresponding development pathways of our companion diagnostics,
actions by the FDA, the EMA or other regulatory authorities
regarding whether to approve drug applications that may be filed,
as well as their decisions regarding drug labeling, and other
matters that could affect the availability or commercial potential
of our drug candidates or companion diagnostics. Clovis
Oncology does not undertake to update or revise any
forward-looking statements. A further description of risks and
uncertainties can be found in Clovis Oncology’s filings with
the Securities and Exchange Commission, including its Annual
Report on Form 10-K and its reports on Form 10-Q and Form 8-K.
Myriad Genetics
Media Contact:
Ron Rogers, (908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason, (801) 584-1143
sgleason@myriad.com
Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
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