DELCATH RECEIVES VALUE 4 REIMBUREMENT STATUS FOR CHEMOSAT IN GERMANY
February 03 2015 - 7:01AM
NEW YORK
(February 3, 2015) - Delcath Systems, Inc. (NASDAQ: DCTH)
announces that the Institut für das Entgeltsystem im Krankenhaus
(InEk), the German federal reimbursement agency, has affirmed Value
4 coverage status for 2015 for the treatment of patients with liver
metastases with the Delcath Hepatic CHEMOSAT®
Delivery System.
Under the Neue Untersuchungs und
Behandlungsmethoden (NUB) reimbursement scheme, Value 4 Status does
not mandate reimbursement but does permit cancer centers to
negotiate for reimbursement coverage for designated procedures with
insurers serving their region. InEk first established NUB
Value 4 status for CHEMOSAT procedures in 2013, and affirmed this
assessment for 2014 and 2015. The NUB is an annual process
and participating centers in Germany are required to apply each
year for subsequent coverage under the scheme. The InEk determines
three status levels for medical procedures submitted for its
review: Value 1 (mandated reimbursement), Value 2 (declined for
reimbursement), and Value 4 (negotiated reimbursement). The InEk
may also decline to make a determination regarding an
application.
Commenting on the announcement,
Jennifer K. Simpson, Ph.D., Interim President and CEO of Delcath
Systems, said, "While we are pleased to have received Value 4
coverage status again in 2015, we continue to expect the primary
mechanism for reimbursement to be Individual Funding Requests
(IFRs), or case-by-case appeals for reimbursement made to a
patient's insurance carrier. While each IFR is evaluated
independently, the majority of applications for CHEMOSAT procedures
were approved in 2014, and included coverage from a range of
sickness funds across a number of regions in Germany. In 2015, we
expect that patients in Germany will continue to have access to
treatment with CHEMOSAT via the IFR reimbursement mechanism."
About Delcath
Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology with a principal focus on the treatment of primary and
metastatic liver cancers. Our proprietary Melphalan Hydrochloride
for Injection for use with the Delcath Hepatic Delivery System
(Melphalan/HDS) is designed to administer high-dose chemotherapy to
the liver while controlling systemic exposure. In April 2012 we
obtained authorization to affix a CE Mark to our second-generation
system, which is currently marketed in Europe as a device under the
trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan
(CHEMOSAT). In the U.S. the Melphalan/HDS system is considered a
combination drug and device product, and is regulated as a drug by
the U.S. Food and Drug Administration (FDA). The Melphalan/HDS
system has not been approved for sale in the U.S. We have commenced
a global Phase 2 clinical trial in Europe and the U.S. to
investigate the Melphalan/HDS system for the treatment of primary
liver cancer, and in 2015 we expect to initiate a global Phase 3
trial in ocular melanoma that has metastasized to the liver and
plan to evaluate intrahepatic cholangiocarcinoma in a Phase 2
clinical study.
Private
Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements made by the Company or on its behalf.
This news release contains forward-looking statements, which are
subject to certain risks and uncertainties that can cause actual
results to differ materially from those described. Factors that may
cause such differences include, but are not limited to,
uncertainties relating to: the timing and results of the
Company's clinical trials including without limitation the
HCC, ICC and OM clinical trial programs timely
enrollment and treatment of patients in the global Phase 2 HCC and
ICC clinical trial, FDA approval of the global Phase 3 OM clinical
trial protocol, IRB or ethics committee clearance of the Phase 2
HCC/ICC and/or Phase 3 OM protocols from
participating sites and the timing of site activation and subject
enrollment in each trial, the impact of the presentations at ESSO
and future clinical results consistent with the data presented,
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure, the impact, if any of Value 4 status on
potential CHEMOSAT product use and sales in Germany, clinical
adoption, use and resulting sales, if any, for the CHEMOSAT system
to deliver and filter melphalan in Europe including the key markets
of Germany and the UK, the Company's ability to successfully
commercialize the Melphalan HDS/CHEMOSAT system and the potential
of the Melphalan HDS/CHEMOSAT system as a treatment for patients
with primary and metastatic disease in the liver, our ability to
obtain reimbursement for the CHEMOSAT system in various markets,
the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter and provide the same in a timely manner,
approval of the current or future Melphalan HDS/CHEMOSAT system for
delivery and filtration of melphalan or other chemotherapeutic
agents for various indications in the U.S. and/or in foreign
markets, actions by the FDA or other foreign regulatory agencies,
the Company's ability to successfully enter into strategic
partnership and distribution arrangements in foreign markets and
the timing and revenue, if any, of the same, uncertainties relating
to the timing and results of research and development projects, our
ability to maintain NASDAQ listing, and uncertainties regarding the
Company's ability to obtain financial and other resources for any
research, development, clinical trials and commercialization
activities. These factors, and others, are discussed from time to
time in our filings with the Securities and Exchange Commission.
You should not place undue reliance on these forward-looking
statements, which speak only as of the date they are made. We
undertake no obligation to publicly update or revise these
forward-looking statements to reflect events or circumstances after
the date they are made.
Contact
Information: |
Investor Contact: |
Media Contact: |
Michael Polyviou/Doug Sherk |
Doug Sherk |
EVC Group |
EVC Group |
212-850-6020 |
212-850-6021 |
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Source: Delcath Systems, Inc via Globenewswire
HUG#1891224