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 on April 11 after identifying what it described as “significant concerns with the manufacturing process” during an inspection in January. The nature of those concerns was not released at the time.
The 60-employee company in St. Catharines, Ont., was forced to shutter its operations, but disputed Health Canada’s findings. Biolyse has maintained that it has always adhered to stringent industry safety standards.
Biolyse says it supplies about 80 per cent of the Canadian market for paclitaxel, a drug commonly used to treat breast, ovarian and lung cancers.
The company said it was informed late on Wednesday that its licence was being returned to active status after a three-day inspection of its premises in late May.
“We’re relieved, and it comes at a fraction of time between bankruptcy and success,” Biolyse president Brigitte Kiecken said on Thursday from St. Catharines.
“Since we couldn’t distribute, we couldn’t produce, we couldn’t do anything,” said Ms. Kiecken, adding that the company hopes to be up and running again in a month.
A Health Canada spokesman confirmed that Biolyse’s licence has been reinstated, but noted it “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 e-mail.
In the meantime, supplies of paclitaxel are available from another manufacturer that is licensed to produce the drug, Health Canada said.