Merck Announces Plans to Construct New Facility in the United States to Expand Manufacturing Capacity for TICE® BCG

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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.

 

About Merck

For more than 125 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.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2019 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

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Pamela Eisele
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