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Delcath Systems (DCTH) Modifies the Label Indication on Chemosaturation System NDA

December 5, 2012 5:34 PM EST
Delcath Systems, Inc. (NASDAQ: DCTH) announced today that after recent discussions with the U.S. Food & Drug Administration (FDA), management has elected to modify the label indication it is seeking in its New Drug Application (NDA) for its proprietary chemosaturation system with melphalan hydrochloride for injection.

Although the Company's Phase 3 trial demonstrated a very positive signal in patients with liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath has decided to focus the Company’s NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver, stated a press release.

This decision is primarily due to the fact that 90% of the patients enrolled in the Company’s Phase 3 trial had ocular melanoma metastases to the liver and the statistically significant efficacy data generated in the trial for this disease. Additionally, FDA-approved treatment options have evolved significantly for metastatic cutaneous melanoma over the past several years, while treatment options for unresectable metastatic ocular melanoma continue to be lacking. Given these facts, the Company believes that its data in ocular melanoma metastases in the liver, coupled with the large unmet need for treatments for this disease, presents the most compelling case for the Company's NDA. The Company hopes that a timely approval of its Chemosaturation system will represent an important step to bring benefits to those cancer patients afflicted with the disease.

"We are very appreciative of the FDA's interest in our NDA and the progress made to date towards our June 15th 2013 PDUFA goal date," said Eamonn P. Hobbs, President & CEO of Delcath Systems. "Assuming our NDA is approved, we believe our decision to focus the initial labeling of our proprietary chemosaturation system on ocular melanoma, where there is a significant unmet medical need, will have little impact on the Chemosaturation system’s revenue potential in the U.S., where physicians typically prescribe cancer treatment options based on clinical data and medical professional experience."

"We plan to initiate clinical studies in 2013 to study the use of our chemosaturation system in other tumor types that potentially represent significant commercial opportunities beyond the ocular metastatic melanoma market. Currently, we intend to pursue studies to support label expansion for the use of our system to treat hepatocellular carcinoma and neuroendrocrine cancer patients, and depending on feedback from the FDA could potentially enroll our first patients before the end of 2013."

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