Irvine-based Spectrum Pharmaceuticals Inc. said Wednesday the Food and Drug Administration approved a mid-stage clinical trial for ozarelix, its drug candidate to treat enlarged prostate.
The trial is expected to involve 100 men who’ll receive ozarelix or a placebo on the first and 15th day of the trial, the company said. The men then would be tracked for six months.
Spectrum received a license from Aeterna Zentaris Inc. of Quebec City to develop and market ozarelix for North America and India in 2004.
Under the deal, Spectrum is set to get 50% of any upfront or milestone payments, royalties and profits from Japanese product sales.
Nippon Kayaku Co. has the Japanese rights for ozarelix’s potential cancer uses.
The move is part of a shift by Spectrum away from generic to brand name drugs. Its lead branded drug is Satraplatin, a prostate cancer treatment.
