Canada regulators stop production at Biolyse Pharma in Ontario

A single-product company in Ontario that makes a generic injectable cancer drug for the Canadian market has run afoul of health regulators. Health Canada suspended the license of Biolyse Pharma over "significant concerns with the manufacturing process."

The 130,000-square-foot plant in St. Catherines makes only paclitaxel, used to treat some lung and breast cancers. The April 11 posting by Health Canada was not specific about what it uncovered during a recent inspection, saying only that companies needed to meet good manufacturing practices. It said that use of the Biolyse product on the market would be allowed in the short term. "However, Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved," it said.

The company told the St. Catherines Standard that it disputes the agency's finding and that it believed the drug was safe. It said that it holds about 80% of the market for the drug used by hospitals and cancer centers in the country. According to the Standard, the company makes the drug from an extract of the Canadian yew bush and says that it has brought down the cost of a treatment course to $500 from more than $30,000.

Health Canada noted that patients can get the drug from another supplier licensed to sell it in Canada and that it did not expect any interruption in supply. The agency said it was working with Biolyse to resolve the issues as quickly as possible.

Rick Dykstra, a member of parliament from St. Catherines, said he had been helping the company deal with the 6 issues inspectors raised in their plant visit. The MP vowed there would be no political interference with what Health Canada needed done but that while these matters usually take months to resolve, he believed this can be taken care of within weeks.

According to the Standard the company last year received $2.9 million from the government to build a new 20,000-square-foot clean room, which would have made it possible to manufacture millions more doses per week. It had planned to add nearly 60 jobs.

The FDA has had its own issues with some Canadian manufacturing facilities. Canadian generics and over-the-counter drugmaker Apotex had products from plants in Toronto and Quebec banned from 2009 to 2011, after FDA inspectors found a number of problems. Sanofi ($SNY) continues to feel the effects of a production slowdown at a vaccine manufacturing plant in Toronto that the FDA tagged with a warning letter in 2012. And Indian drugmaker Jubilant Life Sciences said in March that the FDA had given it a clean bill of health on a facility in Montreal that was issued a warning letter in February 2013.

- here's the Health Canada notice
- read the St. Catherines Standard story