Biolyse Faces Bankruptcy if Suspension Isn’t Lifted

Facing potential bankruptcy, Biolyse is hurriedly attempting to convince Health Canada to lift its license suspension for the injectable cancer drug paclitaxel at the same time its sole competitor Hospira has assured health officials that it can fill the demand.

Hospira has told Health Canada that its inventory of paclitaxel can supply the Canadian market for the rest of this year.

But Biolyse President Brigitte Kiecken told The Globe and Mail that the company is on the verge of losing contracts with the group-purchasing organizations that buy chemotherapy drugs for hospitals. She predicted those buyers will now turn to Hospira and force Biolyse to pick up the incremental cost, which could have dire consequences for her company.

"If they buy paclitaxel from the competition at a higher price a vial, we have to pay the difference," she said. "We sell it at $50. The company will be bankrupt before you know it."

Health Canada suspended Biolyse license due to "significant concerns with the manufacturing process." The agency did not lay out what it uncovered during a recent inspection of the company’s plant in St. Caterines, Canada, only saying that companies need to meet good manufacturing practices.

Health Canada will allow any Biolyse product on the market to be used 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 breast and lung cancer drug paclitaxel is Biolyse’s only product, and the company claims to have about 80 percent of the Canadian market share. — Kellen Owings

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