Spectrum reacquires apaziquone rights from Allergan

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) reacquired from Allergan Inc. (NYSE:AGN) rights to develop and commercialize apaziquone in the U.S., EU and other territories. In exchange, Allergan is eligible for undisclosed, single-digit royalties. In 2008, Spectrum granted Allergan exclusive worldwide rights, excluding Asia, to develop and commercialize the compound, an analog of mitomycin C that is reduced by intracellular reductases into active DNA-damaging moieties. Spectrum and Allergan declined to disclose details (see BioCentury Extra, Oct. 29, 2008).

Last April, Spectrum said apaziquone missed the primary endpoint of a difference in the rate of tumor recurrence at two years vs. placebo in two Phase III trials when given following surgical resection of low-grade, non-muscle invasive bladder tumors. However, the company said that pooled data from both trials show that apaziquone did meet the endpoint (p=0.0174). Spectrum, which said it met with FDA to discuss the pooled data, plans to conduct an additional Phase III trial and submit an NDA for apaziquone to treat non-muscle invasive bladder cancer (NIMBC) as a single instillation following transurethral resection of bladder tumor (TURBT). The company did not disclose a time frame for the trial start or NDA submission. ...