Delcath Systems (NSDQ:DCTH) won expanded CE Mark approval in the European Union for its ChemoSat organ-isolating cancer treatment system, landing indication for a new drug used to target liver tumors.
The E.U. regulatory approval allows Delcath to market ChemoSat for use with doxorubicin hydrochloride, an established chemotherapy agent commonly used to treat hepatocellular carcinoma, the most common primarily malignant liver tumor.
"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," president & CEO Eamonn Hobbs said in prepared remarks. "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."
Having the expanded CE Mark in hand may help the company establish new partnerships in Asia, where more than 550,000 new cases of HCC are diagnosed each year, Hobbs added. The median length of survival for a patient in the intermediate stage of HCC is less than 11 months, he said.
Delcath must still overcome regulatory hurdles specific to China in order to penetrate that market, including conducting local clinical trials in order to obtain approval by the China State Food & Drug Administration, according to a press release.
The New York-based device maker plans to pursue ChemoSat approvals in key Asian markets such as China and Korea, but "does not intend to market ChemoSat with doxorubicin injection in the European Economic Area at this time," according to the statement.
The win is more good news for Delcath, which last week announced that the FDA had accepted for review its 2nd new drug application, bringing the device maker 1 step closer to reaching the U.S. market.
Delcath’s ChemoSat uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ from the rest of the body’s bloodstream.
Earlier this year Delcath sold its 1st commercial unit of the ChemoSat system to the European Institute of Oncology, marking the company’s transition from a research & development stage company to a commercial enterprise.
The troubles began when the FDA refused the company’s new drug application over concerns that the information provided was insufficient for review. ChemoSat is regulated as a medical device in Europe, where it won CE Mark approval in April 2011, but as far as the FDA is concerned it is regulated as drug-device combination that also requires new drug labeling.
"The CE Mark that we have in Europe is a very important regulatory approval, because virtually every country in the world outside of the U.S. accepts the CE Mark as a predicate regulatory approval and provides reciprocal approval," Hobbs told MassDevice.com in an exclusive interview in June 2011. "We’ll be leveraging the CE Mark around the world to gain regulatory approval in all the emerging markets in relatively short order. We expect to have regulatory approval in countries in Asia, South America, Central America and Canada, the Middle East and Africa starting in 2012. We should have regulatory approval in virtually all the countries by the end of 2013."