Gilead Sciences Inc. Gains Orphan Drug Status For Liver Treatment

Gilead Sciences Inc.

obtained orphan drug status on Monday for its simtuzumab as a treatment for a rare disorder related to the liver. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=458214 The designation, which concerns its potential as a treatment for primary sclerosing cholangitis, may provide Gilead increased patent protection and lower regulatory hurdles. The status is reserved for treatments of diseases that affect fewer than 200,000 people in the U.S., or for drugs that aren't expected to recover development costs. Liver transplant is the only current treatment for primary sclerosing cholangitis. Gilead is also attempting to develop simtuzamab as a treatment for liver Fibrosis and nonalcoholic steatohepatitis. Simtuzamab in September proved unsuccessful in a Phase II trial as a treatment for pancreatic cancer. Shares of the Foster City, Calif. company changed hands recently at $99.30, up $1.65.