NEW YORK, Dec. 27, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Company has entered into an initial launch and training agreement for the Delcath Hepatic CHEMOSAT® Delivery system with Johann Wolfgang Goethe University Hospital (J.W. Goethe), a premier European cancer treatment and research center located in Frankfurt, Germany. Under the terms of the agreement, the Company will provide J.W. Goethe with logistics and clinical training support in the performance of chemosaturation therapy using the CHEMOSAT system. The Company expects to conduct the training using the Generation Two version of the CHEMOSAT system, pending CE Mark approval, and for training to begin at the J.W. Goethe University Hospital in February 2012.
University Professor Dr. Thomas J. Vogl, Director of the Institute for Diagnostic and Interventional Radiology at J.W. Goethe, said, "Our team is excited to bring use of the CHEMOSAT system to Germany. Clinical research suggests that chemosaturation therapy using the CHEMOSAT system will offer us a clinically significant tool in treating liver metastases with melphalan. We're eager to begin providing therapy to our patients and exploring the additional potential benefits that the newest generation product from Delcath provides.""This agreement marks another key milestone in the execution of our commercialization strategy for the CHEMOSAT system in the European Union," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "Germany is the largest market in the EU and we are excited to be entering it with a partner as prestigious as J.W. Goethe. CHEMOSAT will be available to patients in Germany soon, and this latest agreement further positions us to begin realizing the system's potential throughout Europe in 2012."
About the Johann Wolfgang Goethe University HospitalFounded in 1914, J.W. Goethe University Hospital is considered to be one of the leading university hospitals in Germany. Twenty-five research institutes working in close cooperation with the Medical Department bear witness to the hospital's strong academic approach. This makes sure that patients coming to the University Hospital for treatment enjoy the benefits resulting from timely implementation of research findings. Every year, around 47,200 and 220,000 patients respectively receive in- and outpatient treatment. The University Hospital possesses special interdisciplinary competence in the fields of neurological science, oncology and cardiovascular medicine.
About Delcath SystemsDelcath Systems, Inc. is a development stage 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 concluded a Phase III metastatic melanoma study, and the Company recently 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 Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at http://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 future use and adoption of the CHEMOSAT system by the J.W. Goethe University Hospital, 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.Contact Information: Investor Contact:Media Contact:Doug Sherk/Gregory GinJanine McCargoEVC GroupEVC Group415-568-4887/646-445-4846-688-0425
|SOURCE Delcath Systems, Inc.|
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