Delcath Systems, Inc: U.S. FDA GRANTS ORPHAN DRUG DESIGNATION TO DELCATH SYSTEMS FOR USE OF MELPHALAN HYDROCHLORIDE IN HCC

   Delcath Systems, Inc: U.S. FDA GRANTS ORPHAN DRUG DESIGNATION TO DELCATH
              SYSTEMS FOR USE OF MELPHALAN HYDROCHLORIDE IN HCC

New York, NY  - October  1, 2013  - Delcath  Systems, Inc.  (NASDAQ: DCTH),  a 
specialty pharmaceutical  and  medical  device company  focused  on  oncology, 
announced today that the U.S. Food & Drug Administration (FDA) has granted the
Company orphan drug designation  for melphalan in  the treatment of  patients 
with hepatocellular carcinoma (HCC, or primary liver cancer).

Orphan-drug designation  is  granted by  the  FDA Office  of  Orphan  Products 
Development to novel drugs or biologics that treat a rare disease or condition
affecting fewer than 200,000 patients in the U.S. The designation provides the
drug developer with a seven-year period  of U.S. marketing exclusivity if  the 
drug is the first of its type  approved for the specified indication or if  it 
demonstrates superior safety,  efficacy, or  a major  contribution to  patient 
care versus another drug  of its type previously  granted the designation  for 
the same indication. It also provides tax credits for clinical research costs,
the ability to apply for annual grant funding, clinical research trial  design 
assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

Melphalan for use with  the Delcath Hepatic Delivery  System is not  currently 
approved in the United States for the treatment of patients with HCC.

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 the liver, while controlling  the 
systemic exposure  of those  agents. The  Company's initial  focus is  on  the 
treatment of  primary and  metastatic  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 for
melphalan hydrochloride. 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 addition, the Company has
initiated plans to investigate the  Melphalan Hydrochloride for Injection  for 
use with the  Delcath Hepatic Delivery  System for primary  liver cancer.  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 timing  and results  of  the 
Company's future clinical trials including without limitation the HCC  trials, 
FDA approval of the melphalanDelcath Hepatic Delivery System for the treatment
of HCC,, the Company's ability to benefit from the orphan drug designation for
melphalan for the  treatment of  HCC, the  Company's ability  to satisfy  the 
requirements of the FDA's Complete Response Letter and provide the same in a
timely manner, clinical  adoption, use and  resulting sales, if  any, for  the 
CHEMOSAT system to  deliver and  filter melphalan  in Europe,  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, our ability  to obtain reimbursement  for the  CHEMOSAT 
system in various markets, 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  and 
revenue, if any, of the same, uncertainties relating to the timing and results
of research and development projects,, and uncertainties regarding our 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.

ContactInformation:
Investor Contact:                Media Contact:
Michael Polyviou/Patty Eisenhaur John Carter
EVC Group                        EVC Group
212-850-6020/951-316-0577        212-850-6021

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Source: Delcath Systems, Inc via Thomson Reuters ONE
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