Canada's Biolyse Pharma is scrambling to convince regulators that its manufacturing standards meet their expectations before competitors eat its lunch. The company's president says if authorities don't soon lift the suspension Biolyse will go bankrupt as competitors grab its market share for the injectable cancer drug paclitaxel, its only product.
|Hospira CEO F. Michael Ball|
The sole competitor right now is Hospira ($HSP), which has assured health officials that it can fill the demand for the product created last week when Health Canada suspended the license of Biolyse over "significant concerns with the manufacturing process." Biolyse claims to have had about 80% of the market share in Canada, where it produces only the breast and lung cancer drug.
Hospira spokesman Daniel Rosenberg said in an email that his company is working closely with Health Canada to meet current needs. "Our first priority is to supply the market and help prevent shortages, and we believe our current inventory can cover the Canadian market through the remainder of 2014," Rosenberg said. "We've made significant investments over the last several years to help ensure continuity of product supply and prevent market disruptions." It is not the only situatioin the Lake Forest, IL-based company has benfitted from. Hospira CEO F. Michael Ball reported earlier this month that "off contract" sales of other products in short supply had boosted earnings in its last quarter.
Losing even some of its market share to Hospira, or others, will be a real problem for the Ontario-based Biolyse and its 60 employees, said President Brigitte Kiecken. "If they buy [paclitaxel] from the competition at [a higher price] a vial, we have to pay the difference," she told The Globe and Mail. "We sell it at $50. The company will be bankrupt before you know it."
In its April 11 posting Health Canada did not lay out what what it uncovered during a recent inspection at the 130,000 square foot plant in St. Caterines, only that companies needed to meet good manufacturing practices. It said that use of the Biolyse product on the market would be allowed in the short term. City officials have been trying to get governement officials to intervene, fearing the loss of local jobs.
St. Catherines mayor Brian McMullan told the newspaper he understood the health department's need to protect public safety but that the situation for the town was dire. "If your staff are going to force ... a company out of business, we think that deserves the minister's attention. We're saying there's got to be another way besides forcing this company out of business, given that they've got a long and proven track record."
- read The Globe and Mail story