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A year ago, I became aware of Bladder Cancer Canada was trying to get Russian strain BCG approved for Canada to alleviate the MERCK TICE BCG shortage in Canada. I raise some concerns of this approach. Below is the list of my concerns.
Background
The currently licensed tuberculosis vaccine, attenuated Mycobacterium bovis strain Bacillus Calmette-Guérin (BCG), was originally derived from M. bovis. The strains used are all progenies of the original strain attenuated by Calmette and Guérin during 1909–1921. In the absence of lyophilisation or freezing and the production of seed-lots until the 1960 s, the propagation of BCG through continuous passage under different laboratory conditions resulted in the generation of daughter BCG strains with different morphological, biochemical and immunological characteristics. Some of these daughter strains have lost genomic regions that affect their antigenic content, potentially changing their protective efficacy. In other words, the efficacy of BCG of different strains can be different. In 2012, due to the discovery of mold in the Connaught strain BCG production line of Sanofi Canada, the production of Connaught strain BCG was halted and eventually the production facility was shut down due to the lack of the buyer. This is when the BCG shortage started and MERCK increased their production of TICE strain BCGs. The current shortage of TICE strain BCG by MERCK has been going over a year and BCC was informed by MERCK that the current BCG shortage will continue throughout 2020. To alleviate the problem, Bladder Cancer Canada has informed that it is working with Health Canada to allow the use of Russian strain BCG. That is where we are at now.
Below are concerns I have to Russian strain BCG for bladder cancer patients in Canada.
1. Russian strain BCG is not the same as TICE strain BCG, which should require clinical trials to determine especially its efficacy and safety. Our neighbour US had chosen Tokyo-172 strain as a possible supplement / replacement of TICE strain BCG of MERCK. They already started the phase III clinical trials at 150 locations in multiple states led by SWOG. The clinical trial ( NCT03091660 ) had started in Febrary, 2017 with the primary completion date Feb, 2022. The clinical trial involves about 1,000 patients. In Canada, we have not even started the clinical trial of the proposed Russian strain. If it is going to take 5 years for the clinical trial of Tokyo strain, then it seems that it would take and we should take similar length to prove the Russian strain BCG has equivalent efficacy and toxicity as the current TICE strain BCG.
2. Adoption of Russian strain BCG will alienate bladder cancer patients from benefiting the result of BCG related research in US. Up to now, most research done in US involving BCG for bladder cancer could be applied to bladder cancer patients in Canada because the patients in both countries have been using the same TICE strain BCG. If we use Russian strain BCG, we are no longer comparing apple to apple.
3. The reliability of the manufacturer. I do not know if we are going to have a manufacture here in Canada for Russian strain BCG or we are going to import from a foreign country who is currently manufacturing the Russian stain BCG. Even such big pharmaceutical company with $42B revenue company got into the production problem which caused the current shortage. Still, because of the big pocket of the company, it was able to ramp up the production to reduce the impact of the shortage. If I am not wrong a start up company called Veritypharm seems like the one who wants to market Russian strain BCG. I see many Canadian doctors on their scientific advisory board. The company was established in 2016 in Canada. How can we bet the lives of bladder cancer patients to unproven company? Also, their business model fits to such essential drug like BCG which needs to be provided at low cost. Their corporate presentation says “Verity Pharma – Canadian specialty Pharma focus in high demand medical products that relevant Rx Products and currently in short supply from the market. A low risk stable business focused on high profit product”. So their business model does not fit the essential drug like BCG. I do not know who has invested to Verity Pharm. But their business model for intravesical BCG must be to get the BCG from some country who sells the BCG cheap and sell to Health Canada at the equivalent of what Merck charges which is $150-$200 per vial according to a news in USA. Again, I reiterate that intravesical BCG is essential drug for Non muscle invasive bladder cancer patients in Canada. MERCK is not making money from selling intravesical BCG but they can support the cost of manufacturing because they can afford it because they make money from other drugs, e.g. Merck makes $8B a year from Keytruda, the immunotherapy drug which is used for advanced stage bladder cancer. We do not know Verity Pharm can survive in the future, which can put us in undesirable situation again.
So, I would strongly recommend BCC to review if Russian strain BCG is the right choice bladder cancer patients in Canada.
Joe
Link to the company website and corporate presentation of Verify Pharm.
Link to the published paper by Nature for the efficacy difference among different BCG strain.
https://www.nature.com/articles/srep15443
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