Health Canada : Cancer drug maker’s licence reinstated

Health Canada has reinstated the licence of Biolyse Pharma. the manufacturer of the key cancer medication paclitaxel, allowing the Ontario company to resume operations with “amended terms and conditions.”

In April, Health Canada said that it had withdrawn the license for Biolyse facility because of “significant concerns with the manufacturing process,” but did not spell those out. The company said today that it has since demonstrated to Health Canada that its production is in compliance with the agency’s standards, pointing out that the reinspection was conducted by a “new team of Health Canada inspectors.”

Biolyse claimed that it supplies about 80% of the demand for the cancer drug from the Canadian market, selling it at $50 a dose, a price it says saves the national health system millions of dollars a year compared to what it would pay other manufacturers. Biolyse President Brigitte Kiecken last month said the company was scrambling to convince regulators that it was doing what was wanted and had warned that it would soon go out of business if competitors swooped in and took away its customers.

Agencies/Canadajournal