Foundation Medicine and Clovis Oncology Expand Collaboration to Develop Novel Companion Diagnostic for Rucaparib in Ovarian

  Foundation Medicine and Clovis Oncology Expand Collaboration to Develop
  Novel Companion Diagnostic for Rucaparib in Ovarian Cancer

     Companion diagnostic development builds upon regulatory strategy for
      Foundation Medicine’s comprehensive genomic profiling platform and
       differentiated clinical development strategy for Clovis Oncology

Business Wire

CAMBRIDGE, Mass. & BOULDER, Colo. -- April 3, 2014

Foundation Medicine, Inc. (NASDAQ: FMI) and Clovis Oncology, Inc. (NASDAQ:
CLVS) today announced the expansion of their ongoing collaboration to
incorporate a coordinated regulatory strategy for the development of a novel
Premarket Approval (PMA) companion diagnostic test. This test is designed for
use by physicians to identify patients most likely to respond to rucaparib,
Clovis’ poly (ADP-ribose) polymerase (PARP) inhibitor currently the subject of
Phase 2 and Phase 3 clinical trials in patients with ovarian cancer.

This companion diagnostic is being developed in parallel with the clinical
development of rucaparib to facilitate an FDA submission of the PMA for the
companion diagnostic concurrent with the New Drug Application (NDA) for
rucaparib. Foundation Medicine’s platform, upon which the companion diagnostic
will be based, is currently in use in Clovis’ ongoing ARIEL2 clinical study of
rucaparib in patients with ovarian cancer. The test assesses multiple
cancer-related genes as well as all classes of genomic alterations, and it
utilizes advanced algorithms based on Foundation Medicine’s molecular
information platform.

“Patient selection is a key aspect of our development and regulatory strategy
for rucaparib. Ovarian cancer patients often present with a molecular
signature of DNA repair deficiencies beyond germ-line BRCA that cannot be
characterized by the conventional diagnostic tests available today,” said
Patrick J. Mahaffy, president and CEO of Clovis Oncology. “We are pleased to
advance our collaboration with Foundation Medicine and utilize their unique
genomic profiling platform and expertise to identify patients most likely to
benefit from rucaparib.”

Since 2012, Foundation Medicine has been conducting comprehensive genomic
profiling to analyze tissue samples from ovarian cancer patients enrolled in
rucaparib clinical trials in order to identify biomarkers associated with
response. Initial findings identified the molecular signatures of likely
responders, and the companies are now working together to incorporate the
genomic signature into a companion diagnostic test. Under the terms of the
expanded agreement, Foundation Medicine will build a dedicated laboratory to
support the development and FDA-approval of the companion diagnostic test and
will receive milestone payments for its successful development and
registration.

“In addition to helping bring an important new therapy to patients with
ovarian cancer, this collaboration marks a paradigm shift in the development
of companion diagnostics. The use of Foundation Medicine’s platform is an
important step in the evolution of cancer care from a static, single-gene
companion diagnostic approach toward a universal companion diagnostic
standard,” said Michael J. Pellini, M.D., president and CEO of Foundation
Medicine. “This agreement complements Foundation Medicine’s plans to develop
an FDA-approved companion diagnostic and supports our overall strategy to work
with the FDA to establish the appropriate regulatory framework for novel,
comprehensive genomic profiling platforms. We are very pleased to continue our
support of Clovis’ highly differentiated clinical development program and
maintain our efforts with the company to identify the ovarian cancer patients
most likely to benefit from rucaparib.”

About Foundation Medicine

Foundation Medicine^® (NASDAQ: FMI) is a molecular information company
dedicated to a transformation in cancer care in which treatment is informed by
a deep understanding of the genomic changes that contribute to each patient's
unique cancer. The company's clinical assays, FoundationOne™ for solid tumors
and FoundationOne™ Heme for hematologic malignancies, sarcomas and pediatric
cancers, each provide a fully informative genomic profile to identify the
molecular alterations in a patient's tumor and match them with relevant
targeted therapies and clinical trials. Foundation Medicine's molecular
information platform aims to improve day-to-day care for patients by serving
the needs of clinicians, academic researchers and drug developers to help
advance the science of molecular medicine in cancer. For more information,
please visit www.FoundationMedicine.com or follow Foundation Medicine on
Twitter (@FoundationATCG).

Foundation Medicine^® is a registered trademark, and FoundationOne^TM is a
trademark, of Foundation Medicine, Inc.

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 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.

Foundation Medicine Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995, including, but not
limited to, statements regarding a collaboration between Foundation Medicine
and Clovis Oncology, the development by Clovis Oncology of a therapeutic
product for ovarian cancer, the development by Foundation Medicine of a
companion diagnostic test, the creation by Foundation Medicine of a dedicated
laboratory to support the companion diagnostic test, and the development of a
regulatory framework for the FDA approval of comprehensive genomic diagnostic
tests. All such 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 such forward-looking
statements.These risks and uncertainties include that Clovis Oncology may not
successfully develop or obtain regulatory approvals for rucaparib for
treatment of ovarian cancer; that Foundation Medicine may not successfully
develop or obtain regulatory approvals for a companion diagnostic test for
rucaparib; that rucaparib and the Foundation Medicine companion diagnostic
test may not be launched or subsequently achieve successful commercial
acceptance; that the FDA may not support the establishment of a regulatory
framework for approving comprehensive genomic profiling platforms; and the
risks described under the caption “Risk Factors” in Foundation Medicine’s
Annual Report on Form 10-K for the year ended December 31, 2013, which is on
file with the Securities and Exchange Commission, as well as other risks
detailed in Foundation Medicine’s subsequent filings with the Securities and
Exchange Commission. All information in this press release is as of the date
of the release, and Foundation Medicine undertakes no duty to update this
information unless required by law.

Clovis Oncology Forward-Looking Statements

To 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 Clovis Oncology’s
clinical development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the clinical development program for rucaparib, the
corresponding development pathways of its companion diagnostic, actions by
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
rucaparib or its companion diagnostic, including competitive developments.
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.

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Contact:

Foundation Medicine
Media Contact:
Dan Budwick, Pure Communications, Inc.
973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Khaled Habayeb, 617-418-2283
ir@foundationmedicine.com
or
Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
 
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