Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

CENTOCOR SCRAPS SECOND PHASE III CENTOXIN TRIAL, which had been halted in January due to excess deaths in Centoxin-treated patients without gram-negative bacteremia. Centocor is now "evaluating clinical parameters, such as organ failure, and diagnostic tests that measure endotoxemia to better identify... patients [who could benefit from Centoxin] and improve the timing of HA-1A administration," President and CEO David Holveck said March 15. "We believe the trial was flawed in that it failed to identify patients who can benefit from an anti-endotoxin monoclonal antibody like HA-1A," Holveck noted. Centocor plans to meet with FDA and European regulatory officials to discuss issues including a further trial in adults if a test to identify target patients can be found and the feasibility of reinitiating Centoxin sales in Europe. The firm halted European sales of the product in January when the trial was suspended ("The Pink Sheet" Jan. 25, T&G-2). In addition, Centocor has restarted a trial of the drug in patients under 19 years old with fulminant meningococcemia, a gram-negative infection. Centocor had been awaiting an analysis by Bio-Pharm Clinical Services of results from all patients who had enrolled before making a final decision on Centoxin. The final analysis indicated that in patients without gram- negative bacteremia, 14-day mortality was 41% in the Centoxin arm and 38% in the placebo arm, a difference which was not statistically significant. An interim analysis, which did not include patients enrolled close to the suspension date of the trial, also had shown no statistical difference in the mortality rates of the two patient categories, Centocor added.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts