Sanofi to Stop Production of Bladder-Cancer Drug BCG
November 18 2016 - 11:23AM
Dow Jones News
By Peter Loftus
Sanofi SA plans to stop producing a bladder-cancer treatment
that was in short supply for several years, saying it hasn't been
able to restore full production at a Toronto manufacturing plant
that had contamination problems.
Sanofi said in a statement Friday it will cease production of
its version of the drug BCG, which it sells under the brands
TheraCys and ImmuCyst, in mid-2017. A spokeswoman said the company
has tried to fix problems at its Toronto plant, but its efforts
"cannot guarantee the long-term continuity and reliable supply of
the product."
BCG is one of dozens of drugs that has been in short supply in
the U.S. in recent years, many because of manufacturing-quality
lapses. Some 174 drugs were in short supply as of Sept. 30,
according to the University of Utah's Drug Information Service.
Sanofi hasn't supplied BCG for the U.S. market since 2012, when
it suspended production to fix manufacturing-quality problems
raised by U.S. and Canadian regulators. Sanofi had previously
planned to reintroduce the drug to the U.S. market, but now has
dropped those plans.
News on the production halt was reported by Forbes.com late
Thursday.
Merck & Co., the only other supplier for the U.S., has
boosted production to try to fill the gap. Merck's own production
problems at a North Carolina plant squeezed the BCG supply for the
U.S. in 2014 and 2015. But Merck has had a good supply for the past
year, said Erin Fox, director of the Utah Drug Information
Service.
The BCG shortage forced delays in treatment for many patients,
and some were switched to alternatives that doctors said were less
desirable. BCG, a liquid delivered into a patient's bladder, is
typically used to ward off relapses after procedures to remove
early-stage bladder tumors.
The BCG shortage followed a 2012 mold infestation that halted
production for more than two years at Sanofi's Toronto plant.
Sanofi renovated the plant and resumed production in 2014, but at a
reduced capacity, and now supplies BCG doses to Canada, France and
the U.K.
The company expects to be able to continue supplying doses in
Canada, France and the U.K. until the end of 2018. Sanofi said it
has notified health agencies in these countries to give them time
to find alternative suppliers. Manufacturers in Germany, Denmark,
India and Japan also make the product.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
November 18, 2016 11:08 ET (16:08 GMT)
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