Biolyse Pharma under investigation
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60 jobs are on the line at Biolyse Pharma in St. Catharines after the company was temporarily shut down in mid April by Health Canada. The company insists it’s addressed every concern. And the company needs to ship out 35-hundred vials of its cancer fighting drug this week or it will lost its contracts and close down — permanently.
Health Canada inspectors began their investigation at Biolyse Pharma at the end of January, and advised the company what they saw as issues. Biolyse says those issues were being addressed. Then on April 11th, it received an email from Health Canada saying its licence was being suspended immediately ‘to prevent injury to the health of consumers arising from the compromised integrity of manufacturing, testing and documentation’ issues.
“We couldn’t believe it. We had started responding to all their concerns. We had most of them already addressed.”
President Bridget Kiecken says there were minor problems with the air flow system in the clean room — problems that were fixed.
She says in the decade Biolyse has been manufacturing Paclitaxel it’s never had a major infraction. And never been shut down.
Most of the staff has been laid off. The office is empty. May 1st, Biolyse met with Health Canada inspectors to give them proof of what they’ve done. Then Health Canada demanded even more tests. The shutdown continues.
The problem is Biolyse supplies 80 per cent of the cancer fighting drug Paclitaxel to Canadian hospitals. A drug used in breast, lung and ovarian cancers. One-thousand patients in Ontario use Paclitaxel every month.
Three-thousand vials are produced every two weeks. But Biolyse hasn’t been able to deliver these drugs since April.
“We’ve already told our buying groups that we don’t think we’ll be able to supply the product on time. Because they’re being held up.”
If Biolyse shuts down permanently, the company and its sixty employees aren’t the only losers here. So are Canadian taxpayers and cancer patients. Biolyse has
been able to slash the price of Paclitaxel from 30 thousand a course treatment down to 400 dollars.
The price is so low in part because a few years ago Biolyse waged a battle with pharmaceutical giant Bristol Myers Squibb to produce a generic version of the Paclitaxel. A battle Biolyse eventually won.
Princess Margaret Hospital has indicated it’s running low on the drug. It’ll have to get it from another supplier. While there is no shortage at this point, whatever is already in the system will cost more money. Health Canada did not return our phone calls today.
