Foundation Medicine Advances Patient Access to Precision Medicine; Pursues Regulatory Approval for FoundationOne CDx™ in Ja...
March 16 2018 - 2:00AM
Business Wire
-- Chugai to Commercialize Foundation
Medicine’s Suite of Comprehensive Genomic Profiling (CGP) Services
in Japan, Expanding Patient Access to Personalized Cancer Care
--
Foundation Medicine, Inc. (NASDAQ:FMI) today announced that
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), one of Japan's
leading research-based pharmaceutical companies and a member of the
Roche Group, will broaden patient access to Foundation Medicine’s
comprehensive genomic profiling (CGP) services for individuals with
advanced cancer. Specifically, Chugai has filed for regulatory
approval from the Ministry of Health, Labour and Welfare (MHLW) in
Japan for FoundationOne CDx™, which, if approved in Japan, would
enable access to MHLW-approved targeted therapies and
immunotherapies, as well as clinical trials, for patients with
cancer in Japan. Chugai will also lead commercial efforts in Japan
for Foundation Medicine’s suite of CGP assays.
FoundationOne CDx is the first FDA-approved comprehensive
genomic profiling (CGP) assay for all solid tumors that
incorporates multiple companion diagnostics. If approved in Japan
by the MHLW, Chugai will be the Marketing Authorization Holder of
FoundationOne CDx in Japan.
“Seeking approval for FoundationOne CDx in Japan is an important
step for the integration of comprehensive genomic profiling into
oncology clinical care,” said Melanie Nallicheri, chief business
officer and head, biopharma for Foundation Medicine. “Importantly,
an MHLW-approved assay could enable the same
accelerated pathway for companion diagnostic development and
approval that Foundation Medicine has pioneered in the United
States with FDA approval, meeting a critical need today for our
biopharma partners’ global development and commercial efforts. We
look forward to partnering with Chugai, and our biopharma partners,
to expand MHLW-approved companion diagnostics claims on
FoundationOne CDx ensuring patient access to personalized cancer
care.”
FoundationOne CDx assesses genomic alterations in 324 genes
known to drive cancer growth, providing potentially actionable
information to help guide treatment decisions. It is indicated for
use by health care professionals to help inform cancer treatment
management in accordance with professional guidelines for patients
with solid tumors. The first FDA-approved test of its kind for all
solid tumors, FoundationOne CDx is a diagnostic test that acts as:
a broad companion diagnostic for patients who may benefit from
treatment with specific FDA-approved targeted therapies; a CGP test
that includes genomic biomarkers such as microsatellite instability
(MSI) and tumor mutational burden (TMB), to help inform the use of
other targeted oncology therapies, including immunotherapies; a
tool for physicians that identifies patient opportunities for
clinical trial participation; and, an FDA-approved platform for
companion diagnostic development for biopharma companies developing
precision therapeutics.
“This collaboration further enables us to pursue personalized
oncology care in Japan,” said Tatsuro Kosaka, Chugai’s president
and chief operating officer. “Regulatory approval for FoundationOne
CDx would establish validation for the assay in Japan. We’re
excited to collaborate with Foundation Medicine to change the
cancer care treatment paradigm in Japan.”
Japan represents the fourth largest addressable market for next
generation sequencing in oncology following the United States,
China and Germany. The country accounts for approximately 9% of all
global oncology costs. Approximately 52% of all oncology drugs
approved globally between 2011-2015 are available in Japan.1
About FoundationOne CDxFoundationOne CDx is a next
generation sequencing based in vitro diagnostic device for
detection of substitutions, insertion and deletion alterations
(indels), and copy number alterations (CNAs) in 324 genes and
select gene rearrangements, as well as genomic signatures including
microsatellite instability (MSI) and tumor mutational burden (TMB)
using DNA isolated from formalin-fixed paraffin embedded (FFPE)
tumor tissue specimens. FoundationOne CDx is intended as a
companion diagnostic to identify patients who may benefit from
treatment with certain targeted therapies in accordance with their
approved therapeutic product labeling. Additionally, FoundationOne
CDx is intended to provide tumor mutation profiling to be used by
qualified health care professionals in accordance with professional
guidelines in oncology for patients with solid malignant neoplasms.
For a full list of targeted therapies for which FoundationOne CDx
is indicated as a companion diagnostic, please visit
http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
About Foundation MedicineFoundation 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 offers a full suite of comprehensive genomic
profiling assays to identify the molecular alterations in a
patient's cancer and match them with relevant targeted therapies,
immunotherapies 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
http://www.FoundationMedicine.com or follow Foundation Medicine on
Twitter (@FoundationATCG).
About ChugaiChugai Pharmaceutical is one of Japan’s
leading research-based pharmaceutical companies with strengths in
biotechnology products. Chugai, based in Tokyo, specializes in
prescription pharmaceuticals and is listed on the 1st section of
the Tokyo Stock Exchange. As an important member of the Roche
Group, Chugai is actively involved in R&D activities in Japan
and abroad. Specifically, Chugai is working to develop innovative
products which may satisfy unmet medical needs, mainly focusing on
the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura
are collaborating to develop new pharmaceuticals and laboratories
in Ukima are conducting research for technology development for
industrial production. Overseas, Chugai Pharmabody Research based
in Singapore is engaged in research focusing on the generation of
novel antibody drugs by utilizing Chugai’s proprietary innovative
antibody engineering technologies. Chugai Pharma USA and Chugai
Pharma Europe are engaged in clinical development activities in the
United States and Europe.
The consolidated revenue in 2017 of Chugai totaled 534.2 billion
yen and the operating income was 103.2 billion yen (IFRS Core
basis). Additional information is available on the internet at
https://www.chugai-pharm.co.jp/english/.
Foundation Medicine® is a registered trademark and FoundationOne
CDx™ is a trademark of Foundation Medicine, Inc.
Cautionary Note Regarding Forward-Looking Statements for
Foundation MedicineThis 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 Chugai;
the scope and timing of any approval of FoundationOne CDx by the
MHLW; the ability of a MHLW-approved FoundationOne CDx to enable
access to MHLW-approved targeted therapies and immunotherapies, as
well as clinical trials for patients with cancer in Japan; and the
ability for an MHLW-approved assay to enable an accelerated pathway
for companion diagnostic development and approval. 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
the risks that the collaboration does not proceed as expected or
does not meet the objectives of the parties; a delay on the part
of, or failure of, the MHLW to approve FoundationOne CDx; 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, 2017, filed with the Securities and Exchange Commission on
March 7, 2018, 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.
1 Global Oncology Trends 2017. Report by the QuintilesIMS
Institute
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version on businesswire.com: http://www.businesswire.com/news/home/20180315006555/en/
Foundation MedicineMedia:Lee-Ann Murphy,
617-245-3077pr@foundationmedicine.comorInvestors:Kimberly
Brown, 617-418-2215ir@foundationmedicine.comorChugai
Pharmaceutical Co., Ltd.Media:Koki Harada,
+81-3-3273-0881pr@chugai-pharm.co.jporInvestors:Toshiya
Sasai, +81-3-3273-0554ir@chugai-pharm.co.jp
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