Delcath Systems, Inc. Announces CE Marking for Hepatic CHEMOSAT® Delivery System for Use With Doxorubicin Injection
Published: Oct 22, 2012
CE Marking confirms that a medical device complies with the Essential Requirements of the Medical Device Directive, and that the device has been subjected to conformity assessment procedures. Application of the CE Mark provides Delcath with a regulatory pathway for countries in Asia that accept CE Marking as part of their national regulatory requirements. In China, these requirements include conducting a local clinical trial and approval by the China State Food and Drug Administration (SFDA). Delcath intends to seek approvals for the CHEMOSAT system with doxorubicin injection in key Asian markets such as China and South Korea. The Company does not intend to market CHEMOSAT with doxorubicin injection in the European Economic Area at this time.
"Doxorubicin is a drug widely used to treat HCC in Asia, which is where we see the market opportunity for our CHEMOSAT system with doxorubicin injection," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "According to GLOBOCAN, more than 550,000 new cases of HCC in Asia are diagnosed every year, and with median survival of less than 11 months for those patients with intermediate stage disease (Lovet, JM, et al; NEJM 2008), HCC is a prevalent disease in this region. Based upon prior discussions, several potential strategic partners in Asia have indicated that they believe that our CHEMOSAT system with doxorubicin may be well received by the medical community in the region. The availability of a CE Marked doxorubicin system provides us with a regulatory pathway for the product in Asia, and we believe it will help us advance partnership discussions in this market."
About Hepatocellular Carcinoma (HCC)
Hepatocelluar carcinoma (HCC) is the most common primary malignant liver tumor. According to GLOBOCAN 2008, the worldwide incidence of HCC is approximately 750,000 newly diagnosed cases each year, with the annual incidence in Asia over 550,000 and over 400,000 in China alone. In approximately 80% of cases, HCC develops in patients with underlying liver cirrhosis. The most important risk factors for the development of HCC include alcoholic cirrhosis, and hepatitis B and C infection. HCC is usually associated with no specific symptoms, so long as it remains asymptomatic and the diagnosis is made very late. In 80% of cases the tumor at diagnosis is already inoperable, and thus a potentially curative therapy is no longer accessible. Available treatments for HCC include tumor resection in patients with resectable disease, and liver transplantation in a small group of selected patients. Local ablative therapies with curative intent have also been options. Patients with unresectable HCC invariably have a poor prognosis.
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 3 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 2 trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Delcath Hepatic CHEMOSAT(R) Delivery System with melphalan hydrochloride for injection in April 2011 and for the second generation hemofiltration cartridge for CHEMOSAT with melphalan hydrochloride for injection in April 2012. 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 combination with melphalan in the United States. The Company's NDA has been accepted for review by the FDA. The Company is seeking approval for its proprietary chemosaturation system with melphalan hydrochloride as a treatment for patients with unresectable metastatic melanoma in the liver.
For more information, please visit the Company's website at www.delcath.com .
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: our ability to successfully enter into strategic partnership arrangements in key Asian markets and timing of the same, the initiation of clinical trials in key Asian markets with the CHEMOSAT system for doxorubicin and timing and results of the same, approval of the CHEMOSAT system with doxorubicin in key Asian markets, patient outcomes using the CHEMOSAT system with doxorubicin, the contents of the 74 Day FDA letter and our ability to address the same, timing of the PDUFA date, timing of completion of the FDA's review of our NDA, the extent to which the FDA may request additional information or data and our ability to provide the same in a timely manner, FDA approval of the Company's NDA for the treatment of metastatic melanoma to the liver, acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, adoption, use and resulting sales, if any, in the United States, patient outcomes using the Generation 2 system, 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 primary and metastatic disease in the liver, 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, 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