Sanofi discontinuing bladder cancer drug TheraCys after years of production issues

Syringe
Sanofi Pasteur will stop production of bladder cancer vaccine TheraCys BCG Live attenuated at its plant in Canada in mid-2017.

After years of production problems and perpetual shortages, Sanofi Pasteur will stop production of bladder cancer vaccine TheraCys BCG Live attenuated, saying it has been unable to find another company to take the product on.

According to a letter obtained by Forbes contributor Benjamin Davies, Sanofi Pasteur said production at its plant in Canada will stop in mid-2017, so it has decided not to relaunch the product in the U.S.

In an emailed statement Sanofi confirmed it was discontinuing production in mid-2017, but said it expected to continue to supply doses to Canada, France and the U.K.—where the product is currently available—until the end of 2018. It noted that other BCG-IT products are produced by other manufacturers located in the United States, Germany, Denmark, India and Japan.

In the letter published by Forbes, the company said, “Sanofi Pasteur spent considerable time and effort on a formal process to find another company to manufacture and commercialize ImmuCyst/TheraCys worldwide. Several companies were identified and while a certain level of interest was initially expressed, ultimately no party would commit to take on this product."

“We regret any potential impact this decision may have on the needs of patients and their health care providers," the letter added.

Merck & Co. manufactures the only other BCG product available in the U.S. While it had some production interruptions in the past, it said in a statement today that it remains dedicated to its BCG product and expects to be able to pick up demand.

“In 2012, Merck became the only source of TICE BCG in many countries, including the U.S. Thanks to the hard work and dedication of our employees, Merck is now able to meet the increased demand for this medicine around the world. We recognize the importance of this therapy, and will continue to focus on maintaining supply of this medicine in light of the recent Sanofi announcement.”

Intermittent availability of the drugs has been of grave concern to patients with bladder cancer because the alternative to treatment with BCG can mean partial removal of the bladder or a radical cystectomy in which the bladder and most of the sexual organs are removed. Last year there were protests in South Africa by the Treatment Action Campaign, which charged Sanofi with putting "thousands of children's lives at risk by stopping production of BCG with no warning."

The shortages of Sanofi's bladder cancer drug date to 2012 when the FDA slammed the plant over sterility issues after it had been flooded and developed a mold problem. The FDA laid out 24 observations, saying, "there have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas" since August 2010.

In 2015 Sanofi indicated it was prepared to produce the product again, pending FDA approval of the plant, but challenges remained.