November 18, 2016
By Mark Terry, BioSpace.com Breaking News Staff
In an email sent out to urologists, Sanofi Pasteur informed physicians and their patients that it has abandoned the manufacture of TheraCys, BCG Live. This product is the primary treatment used to combat and prevent bladder cancer recurrence.
Sanofi indicated that it had been working to maintain its long-term manufacturing operations, but that it will end its work at its Canada facility in mid-2017. As a result, it won’t be available for patients, and won’t be re-launched in the U.S.
“Sanofi Pasteur spent considerable time and effort on a formal process to find another company to manufacture and commercialize ImmunoCyst/TheraCys worldwide,” the email said. “Several companies were identified and while a certain level of interest was initially expressed, ultimately no party would commit to take on this product. Therefore, the company has decided to discontinue the production of ImmunoCyst/TheraCys, BCG Live attenuated, indicated for the treatment of non-muscle invasive bladder cancer.”
In 2011, the U.S. Food and Drug Administration (FDA) inspected Sanofi’s vaccine laboratory in Toronto. They identified 58 different mold contaminations. “Since Sanofi was not making a blue cheese version of a Stilton BCG—the drug was at severe risk of contamination,” writes Benjamin Davies, for Forbes. “The FDA quickly shut the lab down.”
The facility had been flooded at one point, which is likely responsible for the mold. But the facility had other problems. In 2013, the same facility was distribution pertussis-containing vaccines, Pentacel, Adacel and Daptacel, and was interrupted by an “anomaly.” That caused a drop of vaccine sales that year by more than 7 percent.
That left only Merck to manufacture the drug. But Merck wasn’t able to keep up with demand, and in 2012, shortages were reported. Then Merck also had “an unfortunate batch contamination” that halted supplies.
Merck’s own product is Tice BCG, and at the time, the company increased manufacturing output by more than 100 percent.
Davies writes, “Two years later and Sanofi has the BCG Toronto laboratory cleared to make the drug. Now they have decided to exit, most likely because the profit did not follow the fix.”
But this creates a very real problem for both urologists and patients, if Merck, likely to be the only manufacturer of the drug, isn’t able to keep up with demand. It’s possible, of course, that Merck will handle this fine, particularly since it will basically be operating without competition.
The FDA’s Safety and Innovation Act (FDASIA, Public Law 112-144) calls for drug companies to report in six months before an anticipated shortage. But that appears to be the only thing that happens, a notice goes up on the website.
Davies, who is an associate professor of Urology at the University of Pittsburgh, School of Medicine, goes on to write, “Nobody, particularly in this new off-kilter Trumpian political environment, wants to push new government interventions. In my view, that is exactly what needs to happen. Cancer drugs—and, for that matter, a host of other essential drugs of little profit—should be produced or supported by the government (perhaps with vaccine production as our guide). It is not an ideal solution, but if there is a constant truism in the omnipresent drug shortage debacle is that drug markets are not looking out for the citizens of this country; it’s time our government did.”
Although the biopharma industry doesn’t seem to mind when the government creates a paying market, it’s unlikely to be enthusiastic about increased government intervention, especially if price controls are part of the package. But time will tell.
