NEW YORK, March 19, 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 Instituto Oncologico Baselga (IOB), Grupo Quiron—a private hospital located in Barcelona, Spain. The CHEMOSAT program at the IOB will be led by Javier Cortes, MD, PhD, Partner and Head of Breast Cancer and Melanoma Programs. Dr. Cortes is also the Head of the Breast Cancer and the Melanoma Programs at Vall d'Hebron University Hospital in Barcelona.
Under the terms of the agreement, the Company will provide the IOB with logistics and clinical training support in the performance of chemosaturation therapy using the CHEMOSAT system. Training is expected to take place in May, and upon completion the site will become the first in Spain to offer Delcath's chemosaturation procedure.
Commenting on the announcement, Dr. Cortes, said, "Instituto Oncologico Baselga is committed to providing state-of-the-art treatment to cancer patients in Spain. The data we have seen suggests Delcath's CHEMOSAT system could be a potentially powerful solution in the treatment of cancers in the liver. We are pleased to be the first institution in Spain to begin exploring the potential of this system in patients with liver tumors originating from a variety of cancers."
"This agreement with IOB represents our first inroads into Spain, one of our core target markets," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "The IOB also represents our fifth center in our fourth European market, following on the centers we have established in France, Germany and Italy. We're pleased with the pace of our rollout of CHEMOSAT in the EU, and expect to announce other new agreements in the coming months."
About Grupo QuironThe Quiron Foundation is the inspiration of D. Publio Cordon, who founded Grupo Quiron in memory of his son. The goal was to ensure that both common and advanced medical technologies were available to people with fewer resources. Founded in 1992, the Grupo Quiron now consists of seven hospitals across Spain. Through coordinated efforts between these centers, Quiron Hospitals are at the forefront of modern 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 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 in the United States. 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 Quiron University Hospital, patient outcomes from CHEMOSAT procedures, 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 Group
|SOURCE Delcath Systems, Inc.|
Copyright©2010 PR Newswire.
All rights reserved