Delcath Systems, Inc. (NASDAQ: DCTH) with an Tánaiste and Minister for Foreign Affairs and Trade Eamon Gilmore TD officially opened today the Galway, Ireland, headquarters of Delcath Systems Limited (Delcath Limited), an Irish company under which Delcath will conduct its European operations. Delcath is the developer of the Hepatic CHEMOSAT® Delivery System, a device used in a new therapeutic approach for patients with cancers in the liver.
The CHEMOSAT system delivers concentrated chemotherapy to the liver with manageable systemic toxicity. As many as 56,000 patients in Europe with cancers in the liver could benefit from treatment with the CHEMOSAT system each year.
The opening of its headquarters follows the achievement of several European milestones for Delcath. The Company has established initial launch and training agreements with nine leading cancer treatment centers across Europe, and has recently received its first commercial orders for the CHEMOSAT system.
The Company also recently received CE Mark for the second generation hemofiltration cartridge of the CHEMOSAT system, which has demonstrated removal of chemotherapeutic agent (melphalan hydrochloride) of greater than 98 percent during drug infusion in an in vivo study. With the new hemofiltration cartridge, the CHEMOSAT system may help to improve the management of side effects on treated patients and potentially complement other systemic cancer therapies.
“Galway provides us with an excellent base from which we can continue our commercialization of the CHEMOSAT system in Europe” said Eamonn P. Hobbs, President and CEO of Delcath System, Inc. “This region is the European home for many international medical device and pharmaceutical companies, and we have been able to staff our headquarters with well-qualified, experienced personnel. Together with the assistance provided by IDA Ireland, the area was a natural choice.”
“I am very pleased to have been invited to open the new European headquarters for Delcath in Galway”, said Tánaiste Gilmore. “Delcath is a very welcome and important addition to the strong life sciences sector in Ireland. Delcath joins the growing number of companies who have recognised the depth of healthcare talent available in Ireland to support their plans for business expansion in Europe.”
In welcoming the official opening, IDA Ireland CEO Barry O’Leary said, “Ireland is a leading location for medical device companies with 17 of the top 25 global companies in this industry with operations here. The growth and success of Delcath further adds to Ireland’s reputation as a hub for the life sciences industry and is an important addition to the medical device cluster in the West region.” Delcath Systems Limited is an IDA Ireland supported client company. 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 Delcath Hepatic CHEMOSAT® delivery system in April 2011 and for the second generation hemofiltration cartridge for CHEMOSAT 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 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.
For full IDA Press Release