From www.merck.com:
October 14, 2020 4:10 pm EDT
KENILWORTH, N.J., Oct. 14, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced it will construct a new manufacturing facility to significantly expand its production capacity for TICE® BCG (BCG Live For Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. Since Merck unexpectedly became the only manufacturer of BCG for patients in many countries around the world in 2012, increasing global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future. This investment reaffirms Merck’s longstanding commitment to producing this medicine for the patients who need it.
While this commitment is an important step in making sure that adequate supply of TICE BCG is available, completing construction of a manufacturing facility may take approximately 5 to 6 years. Once construction is complete, and following regulatory reviews and approvals, supplies of TICE BCG will gradually increase over time. This medicine has a lengthy and complex manufacturing process. Each batch takes more than 3 months to make, 30 days of which is waiting for the growth of bacteria used to make the medicine. Our company will work to complete this project and meet patient needs in as timely a manner as possible.
“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. I’d like to recognize and thank all of our manufacturing personnel who have continued to work tirelessly – nights, weekends and holidays — to produce TICE BCG at the highest levels we can using our current facilities.”
The new facility will be part of the existing Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, North Carolina. The facility is expected to create about 100 new jobs locally.
We recognize the impact that supply shortages can have on patients when they cannot receive the medicines they need. Until the new facility is licensed, we will continue to use a system to proportionally allocate TICE BCG based on historical demand within the U.S. and other countries where Merck is the sole supplier, in order to reduce disruption to patient care as much as possible. We continue to focus on maximizing the output and reliability of our current facility striving to provide supply of TICE BCG to patients.
