Last week, Allergan Inc.
(AGN - Free Report
) said that the U.S. FDA has granted fast-track status to apaziquone, an antineoplastic agent which is being studied for the treatment of non-muscle invasive bladder cancer. Apaziquone is being developed by Allergan under a development and commercialization agreement with Spectrum Pharmaceuticals
(SPPI - Free Report
Fast-track designation is usually granted to drugs which are being developed for the treatment of serious diseases and which show the potential to address unmet medical needs. The designation helps accelerate the development and review process.
Non-muscle invasive bladder cancer is a form of cancer localized on the surface of the bladder that has not spread to the deeper muscle layer. The companies estimate that about 70% of all patients newly diagnosed with bladder cancer have non-muscle invasive bladder cancer. More than 1 million patients in the U.S. and Europe are estimated to be affected by the disease, which is treated predominantly by urologists.
Apaziquone is currently in two phase III clinical trials which are evaluating its safety and efficacy in the treatment of non-muscle invasive bladder cancer following surgery - enrollment should be complete by end of the year. If all goes well, apaziquone could hit the market in the 2013-2014 timeframe.
Allergan’s urology portfolio currently consists of Sanctura and Sanctura XR. Once approved, apaziquone should fit well within Allergan’s urology portfolio. Allergan and Spectrum will be co-promoting the product in the U.S. Allergan has exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world. Peak sales in Allergan’s territories could be in the range of $500 million.