A Sanofi Pasteur facility that was sidelined for more than two years after the FDA discovered mold problems is again producing the bladder cancer drug ImmuCyst/TheraCys and Sanofi's BCG vaccine for tuberculosis, which disappeared from the market after Sanofi shut the plant to do upgrades.
The resupply was mentioned in an earnings report by Alliance Pharma, which has an agreement to distribute the product for Sanofi Pasteur in a number of markets. A Sanofi Pasteur spokeswoman confirmed on Monday that Health Canada gave the Toronto facility the go-ahead at the end of October and that production of ImmuCyst/TheraCys and BCG live attenuated product has resumed there. The company is still awaiting an inspection by the FDA. She said that product will progressively be made available starting in the second half of 2015.
"In June 2012, Sanofi Pasteur temporarily suspended production of all BCG products and began renovations to the BCG production building in Toronto and made certain improvements to its manufacturing process. These renovations and processes are completed," Nancy Simpson, director of communications for Sanofi Pasteur, said in an email. "Health Canada inspected the BCG facility and on Oct. 29, 2014 reinstated the Drug Establishment License for the fabrication of BCG products. … Sanofi Pasteur is in communications with the FDA and we expect that an inspection of the facility will be conducted as part of the regulatory process for return to market in the US."
The FDA issued a warning letter for the plant in June 2012 with two dozen observations. Among other problems, the FDA said at the time that there had been at least 58 documented instances of "non-conformances relating to the isolation of mold within the BCG aseptic processing areas" over a two-year period. The plant had previously flooded.
With the loss of the Sanofi products, the FDA turned to Merck ($MRK) to pick up the slack. Merck increased production of its Tice BCG bladder cancer product by more than 100% to help meet the demand. But it also had a manufacturing glitch that interrupted shipments for a while.
The closing of the BCG line was not the only problem at the Toronto plant. In 2013, production and distribution of Sanofi Pasteur's pertussis-containing vaccines, Pentacel, Adacel and Daptacel, to the U.S. was interrupted by what the company called an "anomaly" at the Toronto facility. The disruption whacked more than 7% off Sanofi's vaccine sales for the third quarter of that year and contributed to an earnings shortfall as well.
- here's the Alliance release