Mold may lead to Sanofi cancer drug shortage

Problems with mold at a Sanofi ($SNY) plant that flooded last fall has forced the plant to close for remediation, setting the stage for a global shortage of the bladder cancer drug ImmuCyst.

Last month, Sanofi-Aventis Australia recalled four batches of tuberculosis vaccine BCG and suspended production of the vaccine at the same Toronto plant when Australian regulators found problems with sterility. Production on that line was stopped, creating a shortage of that drug. The same bacterium is used for the treatment of bladder cancer, according to a report from The Canadian Press.

A Sanofi spokeswoman tells the Canadian news service it doesn't expect BCG to be back on the market until the end of 2013. The Toronto facility is the only Sanofi plant that makes the drug and it is the only drug approved for use in Canada, leaving health authorities there scrambling to find alternate supplies. They now find themselves in the same situation with ImmuCyst.

When BCG was recalled, regulators allowed the French company to continue with production of ImmuCyst, trying to avoid a shortage, but now say mold has been found in the sterile production area, The Canadian Press reports. "After conducting a health risk assessment, Health Canada believes that the benefits of the ImmuCyst (bladder cancer) product continue to outweigh any risks," the agency tells The Canadian Press in a statement.

- read The Canadian Press report
- here is the Health Canada announcement