Sanofi to Stop Production of Bladder-Cancer Drug BCG -- Update

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.

A Merck spokeswoman said the company is able to meet the increased demand for BCG around the world, and will try to maintain the supply in light of Sanofis decision.

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 [e-mail]

(END) Dow Jones Newswires

November 18, 2016 13:36 ET (18:36 GMT)

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