The Food and Drug Administration Monday granted Delcath Systems
Inc. (DCTH) seven years of marketing exclusivity for its liver
cancer treatment doxorubicin.
The news sent shares jumping 30% premarket to $3.93.
The New York-based drug developer still needs to undertake
additional clinical study for the treatment, which is used in
combination with Delcath's Percutaneous Hepatic Perfusion
technology. It allows doctors to deliver higher doses of
anti-cancer drugs to the liver without exposing the entire body to
such high levels.
The orphan-drug declaration, beyond the market exclusivity, also
includes some free waivers and potential tax breaks. The FDA can
designate a medication as an orphan drug if the product is intended
to treat a rare disease or condition affecting fewer than 200,000
patients in the U.S. a year. About 20,000 cases of primary liver
cancer are diagnosed a year.
Delcath has posted a string of losses over the last year.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291;
joan.solsman@dowjones.com