During its years as sole producer of a difficult-to-make cancer med in high demand, Merck & Co.’s limited capacity has hamstrung its efforts to get the drug into patients’ hands. Now, Merck is putting its money where its mouth is in a big boost to its production capacity.
Merck & Co. will build a new manufacturing facility in North Carolina to triple production of bladder cancer therapy TICE BCG, a freeze-dried medicine administered by catheter that has been plagued by supply issues for years, the drugmaker said Thursday.
The new plant at Merck’s existing Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, North Carolina, will create about 100 local jobs, the company said in a release.
With a timeline of roughly five to six years to build, the newest Merck plant will add to the existing supply of BCG over time, eventually tripling the drugmaker’s capacity. Merck became the sole producer of the drug worldwide after Sanofi unexpectedly dropped it in 2012, citing production issues.
BCG has long been an issue for manufacturers due to its complicated production process, which can take three months, Merck said. Meanwhile, demand for the drug continues to increase and puts an even larger strain on Merck’s supply chain.
“While this new facility will take a number of years to complete, we look forward to the day when we can meet the needs of all patients whose physicians have prescribed TICE BCG for them,” Julie Gerberding, M.D., Merck’s executive vice president and chief patient officer, said in a release.
In March 2019, Merck restricted shipments of BCG to countries around the world based on historical ordering averages for the drug. The drugmaker tied the decision to maxing out its manufacturing capacity.
As the lone supplier of the drug since 2012, the company said, Merck had doubled its capacity as of early 2019 and cut 40% off its manufacturing time. When Merck decided to limit its shipments, the drugmaker was producing 600,000 to 870,000 vials annually.
In January of that year, the company started “proportionally allocating the medicine across countries where the company is the sole or primary supplier, including the United States,” based on historical averages.
Manufacturing issues for BCG have hamstrung distribution for years, eventually leading French drugmaker Sanofi to quit the race altogether in 2012. Only in 2016 did Sanofi admit that it would no longer ship the drug.
Sanofi’s issues were tied to a devastating Australian inspection in 2012 that led to a recall of four batches of the drug and suspended production at the drugmaker’s Canadian plant.
Another inspection by the FDA at the same Canadian plant several months before had found the drugmaker battling mold in the plant after a flood. The FDA laid out 24 observations, saying the “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.