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Delcath Systems, Inc : DELCATH RECEIVES NOTIFICATION OF PDUFA DATE EXTENSION



 Delcath Systems, Inc : DELCATH RECEIVES NOTIFICATION OF PDUFA DATE EXTENSION

                  New PDUFA Goal Date is September 13, 2013
                       ODAC meeting remains May 2, 2013

NEW YORK, NY  - April 8,  2013 -  Delcath Systems, Inc.  (NASDAQ: DCTH)  today 
announced that the U.S.  Food and Drug Administration  (FDA) has extended  the 
initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the
Company's  New Drug Application (NDA) for the marketing approval of Melblez^TM
Kit (Melblez  (melphalan)  for Injection  for  use with  the  Delcath  Hepatic 
Delivery System), the  Company's proprietary  drug/device combination  product 
for the treatment of patients with unresectable ocular melanoma metastatic  to 
the liver.

On March 18, 2013 the Company  supplied certain information in response to  an 
FDA request. The information related  to clarification regarding the  bridging 
studies that  were performed  between the  filter generations  that were  used 
throughout the  development program.   As the  information was  requested  and 
supplied within 90  days of  the June  15, 2013  PDUFA goal  date, the  agency 
exercised its option to  extend the PDUFA goal  date to provide adequate  time 
for completion of its review. The three-month extension to September 13,  2013 
is the standard extension cycle granted.  

The previously  announced Oncologic  Drugs Advisory  Committee (ODAC)  meeting 
remains unchanged, and the FDA will convene its ODAC Panel on Thursday, May 2,
2013 for review of the Company's NDA. 

 

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:  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,  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), 
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.

ContactInformation:
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
HUG#1690959
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