Delcath Systems, Inc. Announces First Commercial CHEMOSAT Order in Europe

NEW YORK, March 20, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that it has received the first commercial order for the Company’s Hepatic CHEMOSAT® Delivery System from the European Institute of Oncology (Instituto Europeo di Oncologia IEO) a premier cancer treatment and research center in Europe. Delcath previously announced an initial launch and training agreement with the IEO on November 21, 2011.

“The first commercial order of our CHEMOSAT system is a significant milestone in Delcath’s history, marking our transition from a research and development organization to a commercial enterprise,” said Eamonn P. Hobbs, President and CEO of Delcath. “With the recent announcement of our fifth EU training center, we believe our launch plans for Europe are on track, and we expect to announce additional center agreements in the coming months. Meanwhile, the hiring and training of our direct sales force is gathering pace, the staffing of our contract medical science liaison team is continuing and we are evaluating potential third-party distribution partners to cover each of our targets markets in Southern Europe. We believe that our momentum is building and we are taking critical steps toward our goal of establishing CHEMOSAT as a new treatment option for patients with cancers in the liver in Europe.”

CHEMOSAT is a proprietary product that utilizes chemosaturation technology, a minimally invasive, repeatable procedure that delivers high doses of chemotherapeutic drugs directly to the whole liver while minimizing systemic exposure of such drugs. CHEMOSAT received CE Mark in April 2011 as a Class III medical device with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.

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 Hepatic CHEMOSAT delivery system in April 2011. 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: future orders and use of the CHEMOSAT system by IEO and other centers in Europe,future initial launch and training agreements with other cancer centers in Europe, CE Marking for the Generation Two system and the timing of our commercial launch in 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, 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.

SOURCE Delcath Systems, Inc.