NEW YORK, March 15, 2012 /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 the Institut Gustave Roussy (“IGR”), a leading European cancer center located in Villejuif, France. Under the terms of the agreement, the Company will provide the IGR with logistics and clinical training support in chemosaturation therapy using the CHEMOSAT system. The Company expects training at the IGR to begin in April 2012. Upon completion of training, the IGR will be the first cancer center to commercially utilize the CHEMOSAT system to treat patients in France.
Thierry de Baere, Director of the Department of Interventional Radiology at the Institut Gustave Roussy, added, “Research suggests that CHEMOSAT will offer us a clinically meaningful tool against cancers in the liver. We look forward to working with the Delcath team to explore the product’s potential.”
“This agreement obviously builds on our recent momentum in establishing initial training centers to begin the launch of CHEMOSAT in Europe, and we’re pleased to be working with such a prestigious institution as the IGR to introduce the product into France,” said Eamonn P. Hobbs, President and CEO of Delcath System.
About the Institut Gustave Roussy
The Institut Gustave Roussy (“IGR”) is a nonprofit academic entity with global expertise in the mission to fight cancer. Based in Villejuif, France, the IGR is a wholly patient-oriented leading European Comprehensive Cancer Center belonging to the French public hospital service. Created in 1921 by the then rector of the Academy of Paris, Gustave Roussy, the IGR was joined in 1925 by the Regional Centre for the fight against cancer in the Paris suburbs. Located south of Paris on a single site, IGR employs 2,600 professionals working in care, research, and teaching. www.igr.fr
About Delcath Systems
Delcath 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 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 the future use and adoption of the CHEMOSAT system by the Institut Gustave Roussy,uncertainties relating to 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.
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SOURCE Delcath Systems, Inc.
