J&J Puts A Cork In Eprex Problem: Teflon-Coated Stopper May Solve PRCA

Johnson & Johnson believes that the incidence of pure red cell aplasia seen with the overseas epoetin brand Eprex was most likely caused by leaching from rubber stoppers used in vials of the product.

J&J switched to teflon-coated corks for Eprex in early 2003, and the company believes that the decline in PRCA cases since is a sign that the source of the problem has been identified.

An apparent increased incidence in PRCA associated with Eprex compared to other EPO brands had a significant impact on sales of the drug in Europe in 2002 and 2003 (¹ (Also see "J&J Eprex Sales Stabilize As Aplasia Cases Decline; Patient Registry Planned" - Pink Sheet, 21 Jul, 2003.), p. 28).

J&J Exec VP Joseph Scodari described the "likely reason" for the problem during the recent Wharton Health Care Business Conference in Philadelphia.

"On advice of regulators concerned about BSE," J&J made a decision to change the formulation to remove human albumin used as a stabilizer and replace it with the synthetic stabilizer polysorbate 80, Scodari said.

"Five years later," the company saw a spike in PRCA cases, he said. "The likely reason...was the fact that polysorbate 80 was leaching plasticizers from rubber stoppers for the vials."

Scodari discussed the PRCA episode in response to a question about J&J's position on generic biologics. He pointed to the episode as evidence that "biologic products don't behave in the same way as chemical small molecules."

J&J's competitors in the EPO market have made a similar argument based on the Eprex issue (² (Also see "Roche View On Biogenerics: “They Will Come,” But Process Won’t Be Simple" - Pink Sheet, 4 Aug, 2003.), p. 25).

J&J supports the "availability of biosimilar therapies," Scodari said. "We believe as a matter of corporate position that the marketplace should allow for competitors to enter."

However, "we probably are going to need to do some clinical trials to show those products are safe."