Cancer drug maker can resume operations after licence reinstated: Health Canada

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

The federal department pulled Biolyse’s establishment licence April 11 after identifying what it described as “significant concerns with the manufacturing process” during a January inspection. The nature of those concerns was not released at the time.

The 60-employee St. Catharines, Ont., company was forced to shutter its operations, all the while disputing Health Canada’s findings. Biolyse has maintained that it has always adhered to stringent industry safety standards.

The company said it supplies about 80 per cent of the Canadian market for paclitaxel, a drug commonly used to treat breast, ovarian and lung cancers.

On Thursday, a Health Canada spokesman confirmed that Biolyse’s licence has been reinstated, but “has been amended to add terms and conditions to reflect and monitor the commitments made by the company to resolve issues identified during Health Canada’s Good Manufacturing Practices inspection.”

Under the amended licence, Biolyse is prohibited from manufacturing products without installing new equipment, which must be fully inspected by Health Canada.

“Biolyse must comply with the conditions of its establishment licence before it can begin to manufacture paclitaxel for sale to the Canadian market,” the spokesman said by email.

The company said it was informed late Wednesday that its licence was being returned to active status, following a three-day inspection of its premises in late May.

In a release, the company said it has been “anxiously awaiting” the reinstatement of its licence so it can resume operations.

In the meantime, supplies of paclitaxel are available from another manufacturer that is licensed to produce the drug, Health Canada said.

Follow @SherylUbelacker on Twitter