NEW YORK, Feb. 14, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced the Therapeutic Goods Administration (TGA) division of the Australian government has approved the Delcath Hepatic CHEMOSAT® Delivery system for listing on the Australian Register of Therapeutic Goods (ARTG). The TGA's approval allows Delcath to market and sell the system in Australia.
"Regulatory approval in Australia represents another achievement for Delcath as we seek to expand the global addressable markets for our CHEMOSAT system," said Eamonn P. Hobbs, President and CEO of Delcath. "We believe chemosaturation therapy via our CHEMOSAT system will provide an important treatment alternative for liver cancer patients in the Australian market."
Delcath received CE Marking for CHEMOSAT in April 2011 in the European Union, allowing Delcath to market and sell the product in countries in the European Economic Area. In October 2011, Delcath completed the product notification process through its designated sponsor for the CHEMOSAT system with the Medicines and Medical Device Safety Authority in New Zealand.
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 Company's ability to successfully enter into a distribution agreement and commercialize the CHEMOSAT system in Australia and any corresponding revenue, 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 in any market, 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 Gin
Janine McCargoEVC Group
|SOURCE Delcath Systems, Inc.|
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