The French vaccine firm – part of Sanofi – announced the discontinuation in a letter to urologists last week explaining that it has no plans to shift production to another facility after manufacturing stops in mid-2017.
TheraCys, BCG Live consists of an attenuated strain of Mycobacterium bovis.
As a cancer therapy Theracys is administered directly to the bladder via a catheter where it promotes macrophage and lymphocyte infiltration.
The precise mechanism of action is unknown although the anti-tumor activity appears to be T-lymphocyte-dependent.
A Sanofi Pasteur spokeswoman told us TheraCys production “was voluntarily suspended at the Toronto Site back in 2012 due to validation issues with one of the release tests and subsequent observations from Health Canada and the FDA.
“Remediation plans were put in place to address these observations. While the facility was re-licensed in 2014, the impact of these efforts resulted in reduced production capacity limiting our ability to sustainably supply all licensed markets.”
Sanofi will continue to supply doses of the drug to Canada, France, and the UK - where it is currently available -until the end of 2018.
The firm pointed out that it “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 US, Germany, Denmark, India, and Japan.”
Merck & Co is the only firm currently selling an equivalent BCG (Bacillus Calmette-Guerin)–based bladder cancer vaccine in the US.
In related news, the US Food and Drug Administration (FDA) recently issued guidelines on the development of bladder cancer.