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Delcath Systems, Inc : DELCATH ANNOUNCES ODAC MEETING REVIEW DATE FOR ITS PROPRIETARY DRUG/DEVICE COMBINATION PRODUCT DELCATH

  Delcath Systems, Inc : DELCATH ANNOUNCES ODAC MEETING REVIEW DATE FOR ITS
 PROPRIETARY DRUG/DEVICE COMBINATION PRODUCT DELCATH HEPATIC DELIVERY SYSTEM

                        Meeting to be Held May 2, 2013

NEW YORK,  Feb.  27,  2013  -- Delcath  Systems,  Inc.  (NASDAQ:  DCTH)  today 
announced that the U.S. Food  and Drug Administration's (FDA) Oncologic  Drugs 
Advisory  Committee  (ODAC)  will  review  the  Company's  pending  New   Drug 
Application (NDA)  for a  drug/device combination  product with  the  proposed 
trade name Melblez Kit^TM (Melblez (melphalan) for Injection for use with  the 
Delcath Hepatic Delivery System. The  ODAC meeting will be convened  Thursday, 
May 2, 2013, to review the NDA with a proposed indication for the treatment of
patients with unresectable ocular melanoma that is metastatic to the liver.

ODAC panels advise  the U.S. Food  and Drug Administration  on the safety  and 
efficacy of proposed  new cancer therapies.  The FDA is  not legally bound  to 
follow the advice of its advisory committees regarding new drug  applications. 
Delcath's NDA was accepted  by the FDA for  substantive review on October  15, 
2012, and was assigned a Prescription Drug  User Fee Act (PDUFA) goal date  of 
June 15, 2013.

Eamonn P.  Hobbs, President  & CEO  of  Delcath Systems,  said, "Our  team  is 
actively preparing for the ODAC meeting and we look forward to presenting  our 
data for the  safety and efficacy  of Delcath's system  for the treatment  of 
patients with unresectable  ocular melanoma  metastatic to the  liver to  the 
ODAC panel."

TheFDAwill publish materials, including webcast information, pertaining to
the meeting athttp://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm.

Changes to the Advisory Committee meetings calendars may also be found on
theFDAwebsite athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm

About Delcath Systems

Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Our  proprietary drug/device combination product  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),  providing 
a regulatory  pathway for  the CHEMOSAT  Delivery System  for Doxorubicin  for 
countries in  Asia  that accept  the  CE Marking  as  part of  their  national 
regulatory requirements. 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 outcome  of the ODAC  meeting, 
and the impact, if  any, of the advisory  panel's recommendation 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, 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:
Doug Sherk/Gregory Gin   Chris Gale
EVC Group                   EVC Group
415-568-4887/646-445-4801 646-201-5431
                             cgale@evcgroup.com

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Source: Delcath Systems, Inc via Thomson Reuters ONE
HUG#1681364
 
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