DELCATH ANNOUNCES REIMBURSEMENT FOR CHEMOSAT IN GERMANY
NEW YORK, February 4, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today
announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the
German federal reimbursement agency, has established a reimbursement pathway for
the treatment of patients with liver metastases with the Delcath Hepatic
CHEMOSAT(®) Delivery System for melphalan hydrochloride. The decision by the
InEK followed an endorsement by the German Radiology Association, which prompted
47 cancer centers throughout Germany to submit applications under the Neue
Untersuchungs- und Behandlungsmethoden (NUB) scheme for new technology
reimbursement at specific hospitals. The Value 4 status given to the CHEMOSAT
procedure, while not mandating reimbursement, allows participating cancer
centers to negotiate reimbursement coverage for the CHEMOSAT procedure with all
insurers serving their region. Under the NUB scheme, reimbursement pathways will
potentially be available for treatment with CHEMOSAT regardless of primary
cancer origin.
Eamonn P. Hobbs, President & CEO of Delcath said, "This is excellent news for
both patients in Germany and Delcath, as it represents a significant positive
step in our efforts to fully commercialize CHEMOSAT in Europe. This is the first
reimbursement mechanism for our procedure in Germany, the biggest market for
CHEMOSAT in the European Union. It is important to note that the application for
coverage was supported by 47 cancer centers across the country, which we believe
speaks to the medical need physicians in Germany see for CHEMOSAT. We will
continue to work closely with the participating hospitals to achieve
reimbursement with the insurers. With a direct sales force in place and training
of the additional centers in Germany on the way, we are now in a good position
to begin growing this market for CHEMOSAT."
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Delcath's proprietary system for chemosaturation is
designed to administer high dose chemotherapy and other therapeutic agents to
diseased organs or regions of the body, while controlling the systemic exposure
of those agents. The Company's initial focus is on the treatment of primary and
metastatic liver cancers. In 2010, Delcath announced that its randomized Phase
3 clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival. The Company also completed a multi-arm Phase 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT® delivery system for melphalan
hydrochloride in April 2012. Â The right to affix the CE mark allows the Company
to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial
delivery and extracorporeal filtration of doxorubicin hydrochloride injection,
providing a regulatory pathway for the CHEMOSAT Delivery System to deliver and
filter doxorubicin for countries in Asia that accept the CE Marking as part of
their national regulatory requirements. Â The Company has not yet received FDA
approval for commercial sale of its system in the United States. The Company's
NDA has been accepted for filing and substantive review by the FDA. Â For more
information, please visit the Company's website at www.delcath.com.
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: whether each of the 47 cancer centers in Germany
will successfully negotiate and receive reimbursement for the CHEMOSAT procedure
in their region and the amount of reimbursement to be provided, patient outcomes
using the CHEMOSAT system in the EU, patient outcomes using the chemosaturation
system under the EAP, Â timing of completion of the FDA's review of our NDA, the
extent to which the FDA may request additional information or data and our
ability to provide the same in a timely manner, acceptability of the Phase 1, 2
and 3 clinical trial data by the FDA, FDA approval of the Company's NDA for the
treatment of ocular metastatic melanoma to the liver, adoption, use and
resulting sales, if any, in the United States, adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter melphalan in the
EEA, our ability to successfully commercialize the chemosaturation system and
the potential of the chemosaturation system as a treatment for patients with
primary and metastatic disease in the liver, market acceptance of the Gen Two
CHEMOSAT system and patient outcomes using the same, approval of the current or
future chemosaturation system for delivery and filtration of melphalan,
doxorubicin or other chemotherapeutic agents for various indications in the US
and/or in foreign markets, actions by the FDA or other foreign regulatory
agencies, our ability to successfully enter into strategic partnership and
distribution arrangements in foreign markets including Australia and key Asian
markets and timing an revenue, if any, of the same, the approval of the Hepatic
CHEMOSAT Delivery System device to deliver and filter  doxorubicin in key Asian
markets and patient outcomes using the same, our ability to obtain reimbursement
for the CHEMOSAT system, uncertainties relating to the timing and results of
research and development projects, uncertainties relating to the timing and
results of future clinical trials, and uncertainties regarding our ability to
obtain financial and other resources for any research, development 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:
Investors: Financial Media EU Consumer/Medical Media
Gregory Gin/Patty Eisenhaur Janine McCargo Julie Johnson
EVC Group EVC Group Bliss Integrated
646-445-4801/951-316-0577 646-688-0425 503-883-9103
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Delcath Systems, Inc via Thomson Reuters ONE
[HUG#1675162]