Update to supply issue regarding OncoTICE
We know how important it is to get medicines to the people who need them and providing those medicines is at the center of what we do
January 24, 2024
In 2012, MSD unexpectedly became the sole manufacturer of OncoTICE® in many countries around the world. Increasing global demand has outpaced our current maximum manufacturing capabilities. In recognition of the medical need for this product, MSD continues to operate at maximum production capacity. Due to the increasing global demand, MSD has been experiencing a supply shortage for OncoTICE.
In October 2020, we announced our plans to construct a new manufacturing facility in Durham, North Carolina, U.S., to significantly expand our production capacity for OncoTICE. This investment reaffirms our longstanding commitment to producing this medicine, and all our medicines, for patients who need them.
If patients have questions regarding OncoTICE, they should speak with their physicians. Additional information related to the shortage, current allocation practices, and our efforts to increase supply, including construction of a new manufacturing site, is below.
FAQs: supply & availability of OncoTICE
What is the cause of the shortages and backorders for OncoTICE?
Since 2012, when MSD unexpectedly became the sole manufacturer of OncoTICE 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 OncoTICE, this medicine has a lengthy and inherently complex manufacturing process.
Prior to 2012, additional manufacturers supplied the U.S. market with OncoTICE, with MSD providing 30-40% of overall U.S. supply. As other manufacturers exited the U.S. market in 2012, MSD became the sole supplier to the U.S. and increased production of OncoTICE to the full extent of MSD’s current manufacturing capacity. These efforts enabled MSD to double supply of OncoTICE to the U.S. market despite being the only manufacturer, in recognition of the medical need for this product.
Can you provide an update on the new facility?
MSD 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 OncoTICE 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, 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 OncoTICE. 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 MSD’s longstanding commitment to producing this medicine for patients.
Can you please describe how the allocation process works outside the U.S.?
MSD allocates available supply among markets based on historical demand patterns. This process is designed to proportionally allocate OncoTICE to minimize disruption to patient care as much as possible.
Where can I find more information about the availability of OncoTICE??
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.
