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MERCK has announced that it will build a new manufacturing facility in North Caloriana, in the US for Onco-Tice strain of BCG for treatment for non-muscle-invasive bladder cancer. This new facility will triple the production of the BCG. With a timeline of roughly five to six years. Though Canada has escaped the catastrophic BCG shortage, I have been noticing the shortage has been impacting the treatment such as forcing early radical cystectomy for many Americans and giving the patients and their families anxiety for the last couple of years. Australia has been allowing importing other strains of BCG from other countries to deal with the shortage. In the US, the clinical trial for TOKYO-172 strain has been going to secure the second source of BCG and it should complete its Phase 3 clinical trial within a year or two. I would like to say to MERCK that it’s about time to build the new facility as MERCK has been making billions of profit over the last few years selling their immunotherapy drug Keytruda for advanced cancers for many cancers including bladder cancer. Nevertheless, it is great news for future bladder cancer patients who would need BCG treatment.
Hi Joe:
This is great news but I’m wondering why we can’t have our own manufacturing plant in Canada? It would provide for Canadian patients without having to depend on foreign imports and provide some much needed employment especially if it was built in an area like Alberta whose economy is in the tank and has been for several years even pre COVID.
Hi Marysue,
BCG manufacturing does not enough profit. There are no goodwill like patent. I have read somewhere that when WHO released the know how of BCG manufacturing, large pharmaceutical companies withdrew from the market. There are now 19 BCG production facilities in the world, though majority of them manufacture just BCG vaccine for Tuberculosis. Sanofi Pasteur had a facility in Toronto for production of intravesical BCG (ImmuCyst). But FDA issued a warning about molds in their BCG manufacturing process in 2012. In the end, Sanofi Pasteur tried to sell its business bus shut down the manufacturing facility because there were no buyers. That is when Merck ended up being the sole manufacturer of Intravesical BCG for North America and some other countries as you know. I have followed Merck since 2017 when BCG shortage started happening in Canada. Executives including the current CEO have stated that their BCG business does not meet their profit goal. Anyway, I do not think it makes a sense for any company for profit to be involved in BCG business even economically depressed Alberta. Another problem of Canada restarting BCG business is that we have to start culturing our own BCG strain by getting a seed from somewhere and we may end up with BCG Canada Strain. The problem is that BCG Canada strain is different from MERCK Onco-TICE strain BCG. This causes another more serious problem. All researches or clinical trials involving BCG has been based upon Merck Onco-TICE strain. How do we know the efficacy and side effects of the new BCG strain without its own clinical trial? A case in point is the efficacy of Merck Onco-TICE BCG for CIS is 50% after the initial 6 weeks induction therapy, but the efficacy goes up to 80% if 3 weeks maintenance is done. Will the same efficacy be expected from the new BCG strain? Maybe, but it needs another clinical trial. The company with the new BCG strain cannot afford the time and the investment. So, the announcement of a new manufacturing line not only should minimize the risk of the shortage but also avoids additional investment for clinical trials for the BCG with the new strain.
I do not expect this new Canadian company who was trying to market the Russian strain intravesical BCG, which is being manufactured by Serum Institute of India now has no incentive to spend money to market their BCG in Canada because of the recent announcement of the increase production by Merck.
Thanks Joe- I see you wrote this in 2020.
It is great news and we are now in 2026 with fall around the corner. I wonder how the facility is currently operating? Building up the stores of Merck onco-tice to have available would be wonderful.Hi Joe- just curious if there are supplying B.C. now with Merck?
A forum user says they were told the fridge has Merck onco tice in it( as of August 2026!) I recall that urologist we were on that video on BCG said there was no shortage of BCG ( late 2022) and he would not give his patients verity.
TanaHi Tana, I do not have information of exactly which hospital caters which BCG. I assume that both Merck Onco-Tice BCG and Verity- BCG are used in BC.
Initially the treatment protocol for Intravesical BCG by BC Cancer Agency was to use Merck Onco-BCG and when it was not available use Verity-BCG. But I recall that some health care unit did not like dealing with the process involved in switching BCG and opted for Verity-BCG totally. I think this situation changed the BC Cancer recommended treatment protocol and now the treatment protocol was modified in 2022 and now simply states “Brand selection based on product availability and physician’s discretion“. Below is the current BCG treatment protocol by BC Cancer Agency. Also “CIS was added” even if Health Canada’s
“www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Genitourinary/GUBCG_Protocol.pdf”
In a recent pod cast (Jan, 2026), the founder and chief medical officer of Verity Pharmaceutical said that the market share of BCG in Canada is 50: 50 between Merck Onco-Tice and Verity-BCG. In other words, a half of patients in Canada are being prescribed with Merck Onco-Tice and the other halves are being treated with Verity-BCG. Back in 2019, according to the BCC website, Merck had promised to supply 80-100% to Canada during Onco-Tice BCG shortage. This was before Verity-BCG. In this sense, there are not BCG shortage in Canada now.
What is happening with the construction of the Merck’s new BCG manufacturing facility?
The latest update on this matter I am aware of was the letter Merck sent in June 2025 to BCAN – the US equivalent bladder cancer patients advocate organization BCC.
“We believe that, barring any unforeseen circumstances, we are on track to complete the project [new manufacturing facility] on time and expect our plant to open by late 2026, following regulatory review and approval. Once operational, our facility is expected to triple our TICE BCG manufacturing capacity, which we anticipate will meet the needs of physicians and patients for the foreseeable future. This expansion represents a significant investment that reaffirms our long-standing commitment to delivering treatment for patients.”
Below is the related information available from Merck website as of May 30, 2025
“Once fully operational, the new facility will triple our current manufacturing capacity, with supply gradually increasing over time, and address global demand for TICE BCG. We’re investing more than $650 million in the new manufacturing facility, which is expected to be fully operational by late 2026 following inspection, regulatory review and approval.” It indicates regulatory review will be also completed by late 2026.
“This medicine has a lengthy and complex manufacturing process. Each batch takes more than three months to make, 30 days of which are spent waiting for the growth of a bacteria used to make the medicine.” So, I assume that at least a batch of BCG had been already produced in the new facility and the test result of the BCG which was manufactured by the new facility so FDA could review as a part of approval process.”
I am sure we will know from different media when Merck announces the completion of the new production facility and detail production plan and availability to patients in the US and Merck’s global customers including Canada.
Addressing the global shortage of TICE BCG – A new facility will triple our manufacturing capacity and address anticipated global demand for TICE BCG for the foreseeable future
“www.merck.com/stories/addressing-the-global-shortage-of-tice-bcg”
Hey- Thanks Joe-
That clears up my question. . This is good info to know.
Amazing the whole process it takes for a batch of onco-tice.
im glad its making a comeback. I would hope my hospital uses it. I am grateful for have had it as it seems to have done the trick so far so good : all clear.
Cheers ,
Tana
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