The orphan drug designation provides eligibility for a seven-year period of market exclusivity in the US after product approval, an accelerated review process, grant funding, tax benefits, and an exemption from user fees.
Steve Kanzer, chairman and CEO of Pipex, said: “Provided that we elect to file an IND for oral tetrathiomolybdate (oral TTM) and pursue the further clinical development of oral TTM for IPF, this orphan drug designation provides additional exclusivity that supports our exclusively licensed issued US patent and pending international patents covering the use of oral TTM for IPF and other high value fibrotic indications.”