In the news release, Delcath Announces Agreement With Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital for Training and Launch of Hepatic Chemosat Delivery System, issued 10-Apr-2012 by Delcath Systems, Inc. over PR Newswire, we are advised by the company that the Netherlands Cancer Institute boilerplate has been updated rather than as originally issued inadvertently. The complete, corrected release follows:
Delcath Announces Agreement With Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital for Training and Launch of Hepatic Chemosat Delivery System
NEW YORK, April 10, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the Company has entered into an initial launch and training agreement with the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL) in Amsterdam, The Netherlands. Under the terms of the agreement, the Company will provide the NKI-AVL with logistics and clinical training support in the performance of chemosaturation therapy using the CHEMOSAT system. Training at the NKI-AVL is expected to begin in May 2012 and upon completion, the site will become the first in The Netherlands to offer Delcath's chemosaturation procedure.
Wim H. van Harten, MD, comm. Med., PhD, Director Organization and Management of the NKI-AVL, said, "The Delcath CHEMOSAT system represents an important new option for the treatment of cancers in the liver, and we look forward to exploring its potential for a range of tumor types."
Warner Prevoo, MD Interventional Radiologist at the NKI-AVL, added, "We've been following the development of the CHEMOSAT system closely since preliminary results from the Phase 3 trial were reported at American Society of Clinical Oncology in 2010. We're pleased that we'll be among the vanguard of medical centers across Europe to begin to offer this treatment for cancers in the liver."
"We are pleased to be working with the NKI-AVL in Amsterdam to introduce CHEMOSAT into The Netherlands," said Eamonn P. Hobbs, President and CEO of Delcath Systems. With this agreement, we now have seven early launch centers in Europe and a presence in nearly all of our core target markets. The NKI-AVL is a longstanding and globally respected institution and we see this new agreement as further realization of our years of research and development."
About the Netherlands Cancer Institute
The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL), Amsterdam, The Netherlands, founded in 1913, is the only Dutch Cancer Centre combining hospital and research laboratories in a single independent organisation. The hospital has 180 beds, a large radiotherapy department and outpatient clinics. The laboratory covers all major areas of cancer research, with special emphasis on genetics, cell biology, immunology and translational research, i.e. using basic knowledge to improve diagnostics and therapy.
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: the future use and adoption of the CHEMOSAT system by theNetherlands Cancer Institute-Antoni van Leeuwenhoek Hospital,future initial launch and training agreements with other cancer centers in Europe, the timing of our commercial launch in Europe and market acceptance of the Generation Two CHEMOSAT system, 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.
Doug Sherk/Gregory Gin