World News: 13:00 GMT Monday 11th February 2019. [Delcath Systems, Inc. via Globe Newswire via SPi World News]
NEW YORK, Feb. 11, 2019 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announces that the Company has received medical device approval for the CHEMOSAT Hepatic Delivery System (CHEMOSAT) from the national health authority in Brazil. The approval of CHEMOSAT as a Class 3 medical device was issued by the Agência Nacional de Vigilância Sanitária (ANVISA), and permits the marketing and utilization of CHEMOSAT under the same percutaneous intra-arterial administration of melphalan hydrochloride to the liver with subsequent extracorporeal filtration of blood indication, as in Europe.
To develop Brazilian market access for CHEMOSAT, Delcath intends to align with a local strategic partner. The Company is already in discussion with several potential candidates with the aim of securing a partnership for the Brazilian market in the first half of 2019, and the intent of commencing revenue generation from that partnership by the end of the year. The Company also intends to expand with partners more broadly across Latin America.
“According to the World Health Organization, liver and bile duct cancers account for over 10,000 deaths in Brazil annually,” said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. “With a population of approximately 200 million, we believe there is a significant unmet medical need in Brazil for CHEMOSAT in both primary and metastatic liver cancers.
“Obtaining approval from ANVISA also provides Delcath with a starting point from which the company can launch other sales channels in the Latin American region,” Dr. Simpson concluded.
Delcath Systems, Inc. is an interventional oncology Company focused on the treatment of primary and metastatic liver cancers. Our investigational product – Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) – is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. We have been enrolling a global Registration clinical trial for Patients with Hepatic Dominant Ocular Melanoma (OM) called The FOCUS Trial and have initiated a global Phase 3 clinical trial for intrahepatic cholangiocarcinoma (ICC) called The ALIGN Trial. Melphalan/HDS has not been approved by the U.S. Food & Drug Administration (FDA) for sale in the U.S. In Europe, our system is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT) and has been used at major medical centers to treat a wide range of cancers of the liver. Since January 2019 CHEMOSAT is marketed under an exclusive licensing agreement with medac, a privately held multi-national pharmaceutical company headquartered in Germany and specializing in the treatment and diagnosis of oncological, urological and autoimmune diseases.
Globe Newswire: 13:00 GMT Monday 11th February 2019
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