Since 2012, when Merck unexpectedly became the sole manufacturer of TICE BCG in many countries around the world, increasing global demand has outpaced our current maximum manufacturing capabilities. While the company has many years of experience producing TICE BCG, this medicine has a lengthy and inherently complex manufacturing process.

Prior to 2012, additional manufacturers supplied the U.S. market with TICE BCG, with Merck providing 30-40% of overall U.S. supply. As other manufacturers exited the U.S. market in 2012, Merck became the sole supplier to the U.S. and increased production of TICE BCG to the full extent of Merck’s current manufacturing capacity. These efforts enabled Merck to double supply of TICE BCG to the U.S. market despite being the only manufacturer, in recognition of the medical need for this product.

Merck is working to complete this project and meet patient needs in as timely a manner as possible. While this commitment is an important step in making sure that adequate supply of TICE BCG is available, completing construction, inspection and regulatory approvals of a manufacturing facility may take approximately five to six years in total. Construction is well underway, and barring any unforeseen circumstances, the new facility is on track to the previously announced timeline and will be completed by late 2025 to late 2026. Supply will gradually increase over time following local market review and approvals.

Once this new facility is fully operational, we expect to triple our current manufacturing capacity of TICE BCG. We anticipate that this will meet the needs of physicians and their patients for the foreseeable future. The investment in this new manufacturing facility reaffirms Merck’s longstanding commitment to producing this medicine for patients.

In the U.S., Merck has been supplying TICE BCG consistently to our network of distributors and wholesalers since allocation began in 2019. Merck allocates available supply among its network of wholesalers and distributors based on historical purchasing. In turn, the wholesalers and distributors allocate their inventory of TICE BCG to their own customers, with guidance from Merck that the allocation should be based on each customer’s historical purchasing patterns. Merck does not directly determine the amount of supply to individual hospitals, hospital pharmacies or medical practices, and these customers cannot order product directly from Merck. This allocation process is designed to proportionally allocate TICE BCG to minimize disruption to patient care as much as possible.

Patients:
Patients should reach out to their physician, as they are in the best position to answer questions about the availability of the medicine in their practice, and can inquire about the quantity and timing of product availability with their supplier.

Health care professionals:
Health care professionals with questions regarding allocation should contact their wholesaler or distributor.