Press Release 25 May 2012

GALWAY, IRELAND – May 25, 2012 – Delcath Systems, Inc. (NASDAQ: DCTH) with an Tánaiste and Minister for Foreign Affairs and Trade Eamon Gilmore TD officially opened today the Galway, Ireland, headquarters of Delcath Systems Limited (Delcath Limited), an Irish company under which Delcath will conduct its European operations. Delcath is the developer of the Hepatic CHEMOSAT® Delivery System, a device used in a new therapeutic approach for patients with cancers in the liver. The CHEMOSAT system delivers concentrated chemotherapy to the liver with manageable systemic toxicity. As many as 56,000 patients in Europe with cancers in the liver could benefit from treatment with the CHEMOSAT system each year.

The opening of its headquarters follows the achievement of several European milestones for Delcath. The Company has established initial launch and training agreements with nine leading cancer treatment centers across Europe, and has recently received its first commercial orders for the CHEMOSAT system. The Company also recently received CE Mark for the second generation hemofiltration cartridge of the CHEMOSAT system, which has demonstrated removal of chemotherapeutic agent (melphalan hydrochloride) of greater than 98 percent during drug infusion in an in vivo study. With the new hemofiltration cartridge, the CHEMOSAT system may help to improve the management of side effects on treated patients and potentially complement other systemic cancer therapies.

“Galway provides us with an excellent base from which we can continue our commercialization of the CHEMOSAT system in Europe” said Eamonn P. Hobbs, President and CEO of Delcath System, Inc. “This region is the European home for many international medical device and pharmaceutical companies, and we have been able to staff our headquarters with well-qualified, experienced personnel. Together with the assistance provided by IDA Ireland, the area was a natural choice.”

“I am very pleased to have been invited to open the new European headquarters for Delcath in Galway”, said Tánaiste Gilmore.  “Delcath is a very welcome and important addition to the strong life sciences sector in Ireland.  Delcath joins the growing number of companies who have recognised the depth of healthcare talent available in Ireland to support their plans for business expansion in Europe.”  

In welcoming the official opening, IDA Ireland CEO Barry O’Leary said, “Ireland is a leading location for medical device companies with 17 of the top 25 global companies in this industry with operations here. The growth and success of Delcath further adds to Ireland’s reputation as a hub for the life sciences industry and is an important addition to the medical device cluster in the West region.”

Delcath Systems Limited is an IDA Ireland supported client company.

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 III 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 II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Delcath Hepatic CHEMOSAT® delivery system in April 2011 and for the second generation hemofiltration cartridge for CHEMOSAT in April 2012. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at www.delcath.com.

The 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 benefits of the Generation 2 CHEMOSAT system and market acceptance of the same, patient outcomes using the Generation 2 system, the timing of the supply and distribution of the CHEMOSAT system to early launch centers Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, acceptance of our IND amendment, the timing and use, if any, of the line of credit from SVB, and our ability to access this facility, 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:
U.S. Investor Contact:
Doug Sherk/Gregory Gin
EVC Group
415-896-6818/646-445-4801

Media Contact:
Julie A. Johnson
BlissHealth
503-883-9103 
julie@blisspr.com

Contact us

Contact IDA Ireland

You'll find us responsive to your needs, proactive, professional and willing to go the extra mile.

Contact IDA Ireland

International Offices

We have 28 Offices worldwide helping support companies expand their operations in Ireland.

Find your nearest office