Spectrum Pharmaceuticals Inc. has regained the marketing rights to its bladder cancer drug apaziquone and announced new progress in discussions of the drug with regulators.
Spectrum said it revised a deal with its partner Allergan Inc., and will have the right to market the drug in the U.S., Europe, and other regions. Allergan will get a royalty payment on sales of the drug if it is approved in those markets. Apaziquone, which the companies had developed under the name EOquin, is designed to treat non-muscle invasive bladder cancer after transurethral resection of the tumor.
The Henderson, Nev., company also said it met with the Food and Drug Administration in December to discuss results from clinical trials of apaziquone. It said the FDA is willing to review its application for marketing approval and that a panel of FDA advisers will probably conduct a hearing on the drug. Spectrum said it has agreed to conduct one more late-stage trial of apaziquone after it consults with the FDA about the design of that trial.
In April 2012, Spectrum said apaziquone had failed in two late-stage trials. The trials were designed to show that patients treated with the drug were less likely to have a tumor recurrence in the two years after their treatment. Spectrum said pooled data from the studies did show a statistically significant treatment effect, however.
Spectrum and Allergan agreed to collaborate on the drug in October 2008. Spectrum received an upfront payment of $41.5 million and Allergan agreed to pay up to $304 million in development, regulatory and sales milestones. Spectrum agreed to help market the drug in the U.S. in exchange for a share of the profits, and it was set to receive royalties on sales in Europe and Canada.
Spectrum said no new drugs have been approved to treat the illness in more than 20 years.
Date: January 31, 2013
Source: Associated Press