DELCATH PROVIDES UPDATE ON FDA ADVISORY COMMITTEE MEETING ON MELBLEZTM KIT
May 02 2013 - 6:05PM
DELCATH PROVIDES
UPDATE ON FDA ADVISORY COMMITTEE MEETING ON
MELBLEZTM KIT
Queensbury,
NY -
May 2, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today
announced that the U.S. Food and Drug Administration's (FDA)
Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no
abstentions that benefits of treatment with Delcath's
MelblezTM Kit (Melblez
(melphalan) for Injection for use with the Delcath Hepatic Delivery
System) for the treatment of patients with unresectable ocular
melanoma metastatic to the liver do not outweigh the risks
associated with the procedure.
The FDA is not bound by the recommendation of its
advisory committee, but will consider the committee's guidance as
it evaluates the Melblez Kit New Drug Application (NDA). The
Prescription Drug User Fee Act (PDUFA) goal date for completion of
the FDA's review and decision regarding approval of the Melblez Kit
NDA is September 13, 2013.
"As we conveyed during the presentation to the
ODAC, we believe our clinical trial data support Melblez Kit as an
effective treatment option offering clinical benefits to patients
with unresectable metastatic ocular melanoma in the liver" said
Eamonn P. Hobbs, President and CEO of Delcath Systems. "While we
were disappointed in today's outcome, we will continue to work
closely with the FDA throughout its ongoing evaluation of Melblez
Kit. We remain committed to providing access to this promising new
treatment for patients who have few choices with regard to
treatments."
About
Oncologic Drugs Advisory Committee Meetings
The FDA's Oncologic Drugs Advisory
Committee (ODAC) consists of a panel of independent experts who
advise the FDA on the safety and efficacy of proposed new cancer
therapies. The panel addresses specific questions raised by the FDA
as the agency considers regulatory decisions. The FDA is not bound
by the committee's recommendation, but the agency takes its advice
into consideration when reviewing new drug applications.
About Delcath Systems
Delcath Systems, Inc. is a specialty
pharmaceutical and medical device company focused on oncology. Our
proprietary drug/device combination product, the Delcath Hepatic
Delivery System, 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. Outside of the United States, our proprietary product to
deliver and filter melphalan hydrochloride is marketed under the
trade name Delcath Hepatic CHEMOSAT® Delivery
System (CHEMOSAT Delivery System for Melphalan.) The Company
obtained authorization to affix a CE Mark for the Generation Two
CHEMOSAT Delivery System for Melphalan in April 2012. The
right to affix the CE mark allows the Company to market and sell
the CHEMOSAT Delivery System for Melphalan 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 (CHEMOSAT Delivery System for
Doxorubicin). 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.
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: the
impact of the negative advisory vote by the ODAC panel on the FDA's
decision regarding the Company's new drug application (NDA), 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, additional extensions to
the PDUFA date by the FDA, , 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: |
Investor Contact: |
Media Contact: |
Gregory Gin/Patty Eisenhaur |
Chris Gale |
EVC Group |
EVC Group |
646-445-4801/951-316-0577 |
646-201-5431 |
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Source: Delcath Systems, Inc via Thomson Reuters ONE
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