The Food and Drug Administration granted Metabasis Therapeutics Inc. orphan drug status for MB07133, a drug candidate for the treatment of primary liver cancer, the La Jolla-based company said Sept. 10.
If the drug gains approvals, the orphan status will give Metabasis seven-year market exclusivity. The company could also receive tax credits related to clinical trial expenses and exemption from the FDA prescription drug user fee.
“There is a critical need for effective therapies for primary liver cancer,” said Paul Laikind, president and chief executive officer of Metabasis, in a company statement. “Patients often die within months of diagnosis and at this time, they face this disease without any FDA-approved drug therapy or standard of care. The granting of orphan drug designation should enhance the value of MB07133 as a novel therapy for this fatal disease should it be approved.”
The company trades on Nasdaq as MBRX. In midday trading Sept. 10, company shares were up nearly 10 percent to $3.15.
, Heather Chambers