Senhwa Biosciences Inc. of Taipei and San Diego received the orphan drug designation to CX-4945 for the treatment of cholangiocarcinoma.
CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, the company said.
Orphan drug designation is granted by the FDA to novel drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S. In the US, orphan drug status carries with it seven years of marketing exclusivity following FDA approval.
Under the agreement, Phylogica will receive a milestone payment of $2 million. Phylogica is eligible to receive research, development, and commercialization milestone payments totaling up to $142 million.
