- Sanofi Pasteur will stop producing its version of the bladder-cancer drug treatment BCG, sold as TheraCys/ImmuCyst, in mid-2017, the company said in a statement Nov. 18.
- Sanofi hasn't supplied BCG in the U.S. since 2012; the company said it will continue to supply doses to Canada, France and the U.K., where the product is currently available, until the end of 2018.
- Despite taking significant steps to try to correct problems at its Toronto manufacturing plant, Sanofi's efforts "cannot guarantee the long-term continuity and reliable supply of the product," the company said in a statement. As a result, Sanofi won't relaunch the product in the U.S. BCG has been in short supply in the U.S. in recent years because of manufacturing-quality lapses.
"Sanofi Pasteur has undertaken significant steps to restore production of ImmuCyst/TheraCys and to explore solutions to maintain the long-term availability of the product, these efforts, however, cannot guarantee the long-term continuity and reliable supply of the product. As a result, the company has decided to discontinue the production of ImmuCyst/TheraCys, BCG Live attenuated, indicated for the treatment of non-muscle invasive bladder cancer," said the company in a statement to BioPharma Dive.
"Because a continuous supply of the product will not be available for patients, the product will not be re-launched in the U.S. Note that Sanofi Pasteur is not the only manufacturer of BCG-IT on a global basis. There are other BCG-IT products produced by other manufacturers located in the United States, Germany, Denmark, India, and Japan," the company added.
Sanofi Pasteur informed the U.S. Food and Drug Administration and also notified health agencies in Canada, France and the UK of its decision in order to allow them time to source BCG-IT products from alternative suppliers, the company said.
Merck, the other BCG supplier for the U.S., has increased production to try to fill the gap, noting that Merck’s own production problems at a North Carolina manufacturing plant tightened the BCG supply for the U.S. in 2014 and 2015. A Merck spokeswoman told the Wall Street Journal that Merck is able to meet the increased demand for BCG globally and will try to maintain the supply in light of Sanofi's decision.