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Bladder Cancer Canada was advised by Sanofi Pasteur today that production of ImmuCyst BCG will cease at their manufacturing facility in Canada in mid-2017; but that they expect to continue to supply doses to Canada until the end of 2018. They have also informed us that this decision is not linked to any safety issues and that all of the doses of BCG which have been released meet all quality, safety and efficacy requirements.
Although the majority of the current Canadian BCG market is using OncoTICE BCG produced by Merck, BCC is concerned about the potential impact of having only one BCG supplier in Canada in the near future and will be taking steps in the coming weeks and months to address patient needs and concerns. More details will be shared on our website and via social media as they unfold.Hi Jack:
Did Sanofi Pasteur give any specific reason for discontinuing production? We can’t have a shortage like before, that would be crazy. I sure hope that BCC will be successful in finding a second supplier of BCG.
I had a lot of stressed out people in my support group with the last shortage.
Sanofi will be making a public statement tomorrow. When it is released I will post on the forum. Be assured that BCC is on top of this serious situation. At least this time we have 2 years in Canada to hopefully get the matter resolved.
JackThanks Jack. I agree. At least this time there is some notice. I’m looking forward to reading Sanofi’s statement. I hope they understand the impact that this decision has on people.
I hope that BCC will be successful in finding another supplier for BCG. Failing that, we have to press on to find another drug that works as well or better than BCG.
SANOFI PASTEUR STATEMENT ON DISCONTINUATION OF BCG
November 21, 2016 – Sanofi Pasteur has undertaken significant steps to restore production of ImmuCyst®/TheraCys® and to explore solutions to maintain the long-term availability of the product, these efforts, however, cannot guarantee the long-term continuity and reliable supply of the product. As a result, the company has decided to discontinue the production of ImmuCyst®/TheraCys®, BCG Live attenuated, indicated for the treatment of non-muscle invasive bladder cancer. Production will cease mid-2017; however we expect to continue to supply doses to Canada, France, and the UK – where the product is currently available -until the end of 2018.
Sanofi Pasteur’s decision to discontinue the production and supply of BCG-IT is not linked to safety issues. All the doses of ImmuCyst®/TheraCys® which have been released to the market meet all quality, safety and efficacy requirements. Sanofi Pasteur is communicating this decision to health agencies in Canada, France and the UK in order to allow them time to source BCG-IT products from alternative suppliers. We regret any potential impact this decision may have on the needs of patients and their health care providers.
…looks like a financial decision at the expense of NMIBC patients..
.. from Yahoo Finance.. “…manufacturing problems at Sanofi (NYSE:SNY), makers of BCG created a worldwide shortage when FDA found mold within the plant. Merck (NYSE:MRK), the only other producer of BCG had its own production problems. In an interview with Forbes, Dr. Joe Eid, Merck Oncology’s Head of Global Medical Affairs, stated batch production of BCG was challenging. Reportedly, it takes three months for a BCG batch to mature and there is no way to tell if the yield is good or bad during that time. These problems force urologists to find new ways to treat patients and will benefit Heat (Biologix)….”
I’m placing my hopes on advances in the field of immunotherapy for cancer in general and timely communication of these trials in Canada.
Kingston and the 1000 Islands
Hi Gerry:
I totally agree. That was the opinion expressed by several of my support group members here in Calgary when we had the shortage before.
I will be honest in saying (I know that people are aware of this) that a shortage of this drug when a suitable replacement hasn’t been found, puts a lot more people’s lives at risk and of course will up the costs to the health care system as more people may have to have a radical cystectomy, especially if they are T1 (Stage 1) and their doctor recommended BCG as an option. It will be very upsetting for people to learn that they have to opt for a big surgery because a certain drug isn’t available that could possibly have helped them avoid the surgery.
This has made me really upset. It is a bunch of political BS. I just hope some fine young mind makes an important discovery that will help.
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