Merck to Build New Facility to Meet BCG Demand

Pipeline Report | <b>Pipeline Report: November 2020</b>

December 17, 2020 - Merck is set to build a new manufacturing facility to increase its production of TICE Bacillus Calmette–Guérin, tripling its current manufacturing capacity.

Merck is set to build a new manufacturing facility to increase its production of TICE Bacillus Calmette–Guérin (BCG), which is currently indicated for the treatment and prophylaxis of patients with carcinoma in situ of the urinary bladder and for the prevention of primary or recurrent stage Ta or T1 papillary tumors following transurethral resection, tripling its current manufacturing capacity.1,2

In 2012, Merck become the sole manufacturer of BCG for patients in many countries around the world, straining the company’s ability to meet global demand for the treatment. With this new facility, the company expects to meet the anticipated demand for TICE BCG for the foreseeable future.

“Our commitment to TICE BCG is at the core of Merck’s mission to save and improve lives,” Julie Gerberding, MD, MPH, executive vice president and chief patient officer of Merck, said in a press release. “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.”

It is anticipated that it could take 5 to 6 years to complete construction before the facility is fully operational, pending regulatory reviews and approvals. Notably, each batch of TICE BCG takes more than 3 months to make, 30 days of which is spent waiting for the growth of bacteria used to make the treatment. Given the complexity of manufacturing TICE BCG, changes in production are expected to be gradual rather than exponential but are promised to “meet patient needs in as timely a manner as possible,” according to Merck.

The new facility will serve as an extension 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.

Until the new facility is licensed, Merck will continue to employ a system to allocate TICE BCG according to historical demand within the United States and other countries dependent on the treatment to minimize disruption to patient care.

“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,” concluded Gerberding.

References

1. Merck announces plans to construct new facility in the United States to expand manufacturing capacity for TICE BCG. News release. October 14, 2020. Accessed November 30, 2020. https://bit.ly/3mKwUEc

2. Persistent BCG shortages lead to hard choices in bladder cancer. OncLive.com. Accessed December 1, 2020. https://bit.ly/2Vz3KM3