Health Canada lets Biolyse restore production of paclitaxel

Biolyse President Brigitte Kiecken

Canada's Biolyse Pharma is back in business. The small company whose sole product is the sterile injectable cancer drug paclitaxel, said that Health Canada had reinstated its license after doing a follow-up inspection at its plant in St. Catherines, Ontario.

In April, Health Canada said that it had withdrawn the license for Biolyse facility because of "significant concerns with the manufacturing process," but did not spell those out.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.

The only competitor right now is Hospira ($HSP), which said it assured health officials that it could fill the demand for the product.

- here's the announcement