Matrix Terminates US AccuSite Program

Matrix Pharmaceutical has ceased development and marketing of AccuSite(fluoruoracil/epinephrine) Injectable Gel for the treatment of genital warts in the USA, it says. Instead, it will channel resources into clinical programs in head and neck cancer and will target other accessible tumors. Shares in the company dropped 32% ($2.31) on the news.

A second action letter received from the US Food and Drug Administration deems the product to be non-approvable for genital warts and focuses on the persistance, in some patients, of a swelling at the injection site.

Matrix said that it was disappointed with the agency's decision, especially as the product has been approved in the UK, and more recently in Ireland and the Netherlands (Marketletter September 15). It added that the FDA reviewers "evidently believe that genital warts is neither a disabling nor life-threatening condition and, consequently, that the potential benefits of treatment with AccuSite do not outweigh side effect concerns." The company feels that this conclusion will be difficult to overcome, and says it will not invest additional resources in the program.