Merck / Durham Update: The Bladder Cancer Drug Made From A Live Bacterial Culture... Will Remain In Very Short Supply For At Least Three More Years.

We recently saw that Merck now projects the Durham facility/line for TICE won't be fully online for another four to five years yet. That's well beyond the 2020 extimate of late 2022. [Our February 2019 backgrounder, on TICE stock-outs, at this link.]

We had guessed, based on experience in the field, that Merck (in October 2020) was about 24 months from seeing new capacity come online -- as a full FDA start up site inspection would be required to get the new plant approved for manufacture. So it goes -- now the "on allocation" status isn't likely to end until some point in 2024 or 2025. Here's WMUR Channel 9 on it all:

. . .Since 2012, when Merck unexpectedly became the sole manufacturer of TICE BCG/OncoTICE in many countries around the world, increasing global demand has outpaced our current maximum manufacturing capabilities. In October 2020, Merck announced it will construct a new manufacturing facility to significantly expand production capacity for TICE® BCG/OncoTICE (BCG Live For Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. Once this new facility is fully operational, it will triple our current manufacturing. We expect that this will support the anticipated demand for TICE BCG/OncoTICE for the foreseeable future. This commitment reaffirms Merck’s longstanding dedication 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/OncoTICE is available, building a new manufacturing facility may take a total of approximately five to six years. This timeline includes construction itself, as well as inspection and regulatory approvals. As of today construction is well underway and plans remain on track to meet this timeline. Once construction is complete, and following regulatory reviews and approvals, supply will gradually increase over time.

This medicine has a lengthy and complex manufacturing process. Each batch takes more than three months to make, 30 days of which is waiting for the growth of a bacteria used to make the medicine. Because of its highly complex and specialized manufacturing and Quality Control testing processes, existing Merck facilities cannot be readily and timely retrofitted used to produce increased supply. . . .

Now you know. Onward, grinning -- ever. . . grinning -- out for a sunny bike ride by the lake.

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