Delcath Gets Special FDA Designation for Therapy
WASHINGTON, Oct. 1, 2013 (AP) — Shares of Delcath Systems Inc. jumped in afterhours trading Tuesday after the medical device and drugmaker said it received preferential regulatory status for its experimental treatment for liver cancer.
THE SPARK: The company said after market's close that the Food and Drug Administration granted "orphan drug" status to its melphalan chemotherapy for primary liver cancer. Drugs granted the designation, which is reserved for rare diseases and conditions, are entitled to seven years of competition-free marketing, as well as tax credits for research and development costs. The designation typically makes it easier for companies to recoup investments on drugs for small patient populations.
THE BIG PICTURE: Delcath is a specialty-drug and medical-device company focused on cancer treatments. It makes a catheter system that treats cancer by delivering high doses of chemotherapy drugs directly to the liver while controlling exposure to the rest of the body.
The FDA is reviewing several uses of the technology, including treatment of inoperable ocular melanoma, a cancer of the eye that can spread to the liver. The system is available in Europe for that use under the name Chemosat.
SHARE ACTION: Delcath Systems Inc. shares rose 9 cents, or 30 percent, to 40 cents in afterhours trading Tuesday.
Posted: October 2013