Hi Sbills,
Thank you for getting the information. It sounds like patients living in the UAE will not experience a BCG shortage. That is great. I have been following the BCG shortage issue for almost 3 years.
I think having multiple sources is the only way to minimize the risk of shortage as the BCG manufacturing process is prone to have a problem as it deals with live bacteria.
BCG is BCG as different BCG manufacturers around the world imported their original seed from the Pasteur Institute in Paris, France. A case in point, when the BCG shortage had happened in 2012 because the company Sanofi Pasteur suspended the production of Connaught strain in their manufacturing facility in Canada, Merck had to ramp up their Tice strain BCG in a single production line in Durham, NC. Many European countries were using Connaught strain BCG and they faced the BCG shortage. So, the European Association of Urology (EAU) issued the guideline to deal with the shortage. The guideline stated "The published meta-analysis of prospective randomized trials did not suggest any difference in efficacy of the BCG strains (Pasteur, Frappier, Connaught, TICE, RIVM). In patients with Ta T1 tumors at high risk of progression or with CIS who are unfit to or unwilling to undergo a cystectomy, there is no scientifically proven alternative to BCG treatment. Thus every effort should be made to obtain an available BCG strain".
Personally, I do not understand why the FDA does not expertise the approval of the Phase III trial of Tokyo-172 BCG, which is running since 2016. I understand that near 800 patients have been on the trial already. The target was 969 patients. So, they should have enough clinical data for the Tokyo-172 strain BCG.
My concern is that the estimated primary completion date of the clinical trial is Feb 2022 and the estimated study completion date is 2025. The estimated completion date of MERCK's new production facility is 5-6 years away. It means we will actual shortage, which is happening now according to some postings in this forum, and risk of continuing shortage for next 3-5 years. This is a big concern.
Incidentally, MERCK sells a vial of freeze-dried 50 mg ONCO-TICE BCG for $150. It looks like CISPA sells its freeze-dried 40mg ONCO-BCG for RS 740, which is equivalent to US$10 according to a medical supply website.
www.medplusmart.com/product/ONCO-BCG-40MG-INJ-CIPLA/ONCO0022