Merck to Construct New Facility in the United States to Expand Manufacturing Capacity for TICE® BCG
January 27, 2021 1:13 pm EST
KENILWORTH, N.J., Jan. 27, 2021 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Board of Directors has approved plans to construct a new manufacturing facility to significantly expand 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 the company’s 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. 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. The Durham plant is part of Merck’s global and U.S. manufacturing network. Merck has continued to invest in its global manufacturing network as part of its planned capital investments of more than $20 billion from 2019 through the end of 2023.
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.
For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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Patrick Ryan 973-275-7075
Peter Dannenbaum 908-740-1037