Centocor R&D To Support Profitability in 1995?

Seemingly having put aside the problems with its one-time lead product Centoxin (HA-1A), Centocor now has a pipeline which is nearing fruition and may support its goal of becoming profitable in 1995.

Flagship of the pipeline is now the monoclonal antibody-based drug CentoRx/Reo-Pro (c7E3), which has been recommended for approval by the US Food and Drug Administration's Cardiovascular and Renal Drugs advisory committee (Marketletter June 20) for the treatment of high-risk angioplasty. The company's manufacturing facilities in Leiden, the Netherlands have now been inspected by the FDA in anticipation of the approval of the drug. Centocor says it is currently working with ReoPro marketing partner Eli Lilly on labeling and promotional materials. Product License Applications have also been filed in Canada and several European countries.

Turning to other indications for the drug, Centocor notes that the Phase III CAPTURE trial has now enrolled 350 patients with unstable angina across Europe, and is on target to have recruited 700 by the end of the year. The total number of patients needed for statistical viability is around 1,400. The trial design includes weight-adjusted heparin in refractory unstable angina patients proceeding to angioplasty.