The pharma giant is currently the only manufacturer of the bladder cancer treatment for the U.S. and Europe.
After a national shortage reached critical levels in 2019, Merck is stepping up to the plate to ramp up its production of a potent, life-saving bladder cancer drug. Merck, known as MSD outside the U.S. and Canada, announced they will construct a new manufacturing facility to significantly expand its production capacity for TICE® BCG (BCG Live for Intravesical Use).
Since 2012, Merck has been the only manufacturer of BCG for patients in the U.S. and European markets. They fell into this position not by choice, but after competitor Sanofi unexpectedly suspended production due to manufacturing-quality problems discovered in an FDA inspection of their Toronto facility. The FDA found 58 mold infractions after a flood at the site. The lab was quickly shuttered and shortages began. Sanofi had intended to return to BCG manufacturing but announced in 2016 that all manufacturing efforts would be halted by mid-2017.
BCG is not a new drug. It was first used in humans in 1921 as a vaccine against tuberculosis. There are some rumblings that the TB vaccine may even help make you less unlikely to get seriously ill when infected with COVID, though that is yet to be proven and the ultimate goal is still a vaccine specifically aimed at coronavirus.
Merck’s form of BCG is a freeze-dried drug deposited directly into the bladder through a catheter typically after a tumor resection has occurred to help prevent recurrence. Patients benefiting most are those categorized with high-risk non-muscle invasive bladder cancer. It is used in early stages as it only affects cells inside the bladder and cannot impact cancer cells once they’ve spread beyond the lining.
The underlying issue in supply is that BCG is a complex biologic that takes about 3 months to make, due to the time it takes the bacteria it’s made from to grow. And with a relatively modest price per dose, it’s not a drug most manufacturers are competing to make.
Although Merck’s new North Carolina facility will take around five to six years to build, it is expected to eventually triple their capacity. The move, particularly knowing this is not a bread-winner for those producing BCG, reaffirms Merck’s commitment to getting patients the treatments they need.
“Our commitment to TICE BCG is at the core of Merck’s mission to save and improve lives,” said Dr. Julie Gerberding, executive vice president and chief patient officer, Merck. “As demand for this medicine has increased over the last several years, we recognized the need to do more. 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.”
The new facility will be part of their existing vaccine manufacturing campus in Durham, North Carolina. About 100 new jobs are expected to be created locally.
Until the facility is up and running, Merck will continue to ration out their current supply of TICE BCG based on historical demand within the US and other countries where they are the sole supplier. Meanwhile, the focus on maximizing current output will continue to try to get the drug to the patients who need it and have no other access to this life-saving treatment.
