Remicade increases mortality in CHF trial

Following evaluation of the preliminary results of an ongoing Phase IIclinical trial, Centocor has said that further development of its tumor-necrosis factor blocker Remicade (infliximab) in the treatment of patients with advanced congestive heart failure has been placed on hold. The results of the trial demonstrated no improvement in patients' clinical status and, moreover, showed a higher incidence of mortality and hospitalization for worsening heart failure in Remicade-treated patients, especially those treated in the higher dose group.

This trial evaluated three infusions - 5mg/kg or 10mg/ kg Remicade or placebo - over six weeks in patients with New York Heart Association Class III-IV CHF. These patients are severely compromised in their ability to perform physical exercise. Overall, seven of 101 patients treated with Remicade died, compared to no deaths among the 49 patients on placebo, according to a "Dear Doctor" letter sent by the firm to disseminate the new findings.

The news is a disappointment for Centocor, as some analysts had suggested that a CHF indication had the potential to double the sales of TNF blockers therapies such as Remicade. Centocor's drug is currently approved for rheumatoid arthritis and Crohn's disease and achieved sales of $209 million in the third quarter of this year (Marketletter October 22), while predictions of turnover for the full-year were in the $750 million range.