CENTOCOR HIT BY CENTOXIN WITHDRAWAL

Centocor has been devastated by the announcement last Tuesday that its flagship monoclonal antibody product, Centoxin (HA-1A), had to be taken off the market in Europe following reports of serious safety concerns revealed in a clinical trial of the product. The product is being sold and investigated as a potential therapy for hospital patients with septic shock syndrome caused by Gram-negative bacteremia.

The clinical trial in the USA was suspended after an interim analysis of the data indicated an excess mortality among certain categories of patients. As a result, the price of the company's shares in the USA plunged by 63% in over-the-counter trading on the news.

Previously, the Food and Drug Administration had requested additional data on the drug after an initial application was rejected on the grounds of unproven efficacy. The company was unable to show a statistically significant reduction in deaths among a broad group of patients; only in those with Gram-negative bacteremia was the drug effective. Safety was not then in question. The FDA therefore requested an additional study to demonstrate efficacy in the latter subgroup of patients.